Trial Outcomes & Findings for A Study for Patients With Type 2 Diabetes Mellitus (NCT NCT00804986)

NCT ID: NCT00804986

Last Updated: 2011-07-14

Results Overview

LSMean adjusted for baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

247 participants

Primary outcome timeframe

baseline, 12 weeks

Results posted on

2011-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	0.5 mg LY2428757 Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	2.0 mg LY2428757 Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	6.2 mg LY2428757 Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	12.0 mg LY2428757 Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	17.6 mg LY2428757 Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	Placebo Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Overall Study STARTED	36	43	42	42	43	41
Overall Study COMPLETED	35	35	40	34	34	31
Overall Study NOT COMPLETED	1	8	2	8	9	10

Reasons for withdrawal

Reasons for withdrawal
Measure	0.5 mg LY2428757 Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	2.0 mg LY2428757 Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	6.2 mg LY2428757 Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	12.0 mg LY2428757 Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	17.6 mg LY2428757 Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	Placebo Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Overall Study Adverse Event	0	1	2	1	3	0
Overall Study Lack of Efficacy	0	0	0	1	0	3
Overall Study Lost to Follow-up	0	0	0	1	1	3
Overall Study Protocol Violation	0	1	0	1	0	0
Overall Study Withdrawal by Subject	0	3	0	3	5	3
Overall Study Inclusion/Exclusion criteria not met	0	2	0	1	0	1
Overall Study Sponsor Decision	0	1	0	0	0	0
Overall Study Physician Decision	1	0	0	0	0	0

Baseline Characteristics

A Study for Patients With Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.5 mg LY2428757 n=36 Participants Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	2.0 mg LY2428757 n=43 Participants Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	6.2 mg LY2428757 n=42 Participants Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	12.0 mg LY2428757 n=42 Participants Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	17.6 mg LY2428757 n=43 Participants Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	Placebo n=41 Participants Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	Total n=247 Participants Total of all reporting groups
Age Continuous	54.5 years STANDARD_DEVIATION 8.06 • n=39 Participants	54.6 years STANDARD_DEVIATION 8.33 • n=41 Participants	56.4 years STANDARD_DEVIATION 8.07 • n=35 Participants	55.2 years STANDARD_DEVIATION 9.78 • n=31 Participants	54.0 years STANDARD_DEVIATION 9.45 • n=146 Participants	56.3 years STANDARD_DEVIATION 9.88 • n=19 Participants	55.2 years STANDARD_DEVIATION 8.93 • n=147 Participants
Sex: Female, Male Female	15 Participants n=39 Participants	20 Participants n=41 Participants	24 Participants n=35 Participants	18 Participants n=31 Participants	22 Participants n=146 Participants	24 Participants n=19 Participants	123 Participants n=147 Participants
Sex: Female, Male Male	21 Participants n=39 Participants	23 Participants n=41 Participants	18 Participants n=35 Participants	24 Participants n=31 Participants	21 Participants n=146 Participants	17 Participants n=19 Participants	124 Participants n=147 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 participants n=39 Participants	4 participants n=41 Participants	1 participants n=35 Participants	4 participants n=31 Participants	1 participants n=146 Participants	3 participants n=19 Participants	15 participants n=147 Participants
Race/Ethnicity, Customized Asian	1 participants n=39 Participants	1 participants n=41 Participants	3 participants n=35 Participants	1 participants n=31 Participants	0 participants n=146 Participants	1 participants n=19 Participants	7 participants n=147 Participants
Race/Ethnicity, Customized Black or African American	9 participants n=39 Participants	6 participants n=41 Participants	8 participants n=35 Participants	6 participants n=31 Participants	10 participants n=146 Participants	8 participants n=19 Participants	47 participants n=147 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	0 participants n=39 Participants	1 participants n=41 Participants	1 participants n=35 Participants	1 participants n=31 Participants	0 participants n=146 Participants	0 participants n=19 Participants	3 participants n=147 Participants
Race/Ethnicity, Customized White	24 participants n=39 Participants	31 participants n=41 Participants	29 participants n=35 Participants	30 participants n=31 Participants	32 participants n=146 Participants	28 participants n=19 Participants	174 participants n=147 Participants
Race/Ethnicity, Customized Multiple Race	0 participants n=39 Participants	0 participants n=41 Participants	0 participants n=35 Participants	0 participants n=31 Participants	0 participants n=146 Participants	1 participants n=19 Participants	1 participants n=147 Participants
Region of Enrollment United States	11 participants n=39 Participants	17 participants n=41 Participants	12 participants n=35 Participants	18 participants n=31 Participants	16 participants n=146 Participants	19 participants n=19 Participants	93 participants n=147 Participants
Region of Enrollment Mexico	2 participants n=39 Participants	4 participants n=41 Participants	1 participants n=35 Participants	4 participants n=31 Participants	2 participants n=146 Participants	4 participants n=19 Participants	17 participants n=147 Participants
Region of Enrollment Spain	0 participants n=39 Participants	0 participants n=41 Participants	1 participants n=35 Participants	1 participants n=31 Participants	2 participants n=146 Participants	0 participants n=19 Participants	4 participants n=147 Participants
Region of Enrollment Ukraine	4 participants n=39 Participants	4 participants n=41 Participants	9 participants n=35 Participants	5 participants n=31 Participants	7 participants n=146 Participants	5 participants n=19 Participants	34 participants n=147 Participants
Region of Enrollment Romania	4 participants n=39 Participants	5 participants n=41 Participants	6 participants n=35 Participants	5 participants n=31 Participants	3 participants n=146 Participants	1 participants n=19 Participants	24 participants n=147 Participants
Region of Enrollment Austria	4 participants n=39 Participants	2 participants n=41 Participants	0 participants n=35 Participants	1 participants n=31 Participants	0 participants n=146 Participants	0 participants n=19 Participants	7 participants n=147 Participants
Region of Enrollment South Africa	10 participants n=39 Participants	8 participants n=41 Participants	10 participants n=35 Participants	6 participants n=31 Participants	8 participants n=146 Participants	7 participants n=19 Participants	49 participants n=147 Participants
Region of Enrollment Germany	1 participants n=39 Participants	2 participants n=41 Participants	3 participants n=35 Participants	2 participants n=31 Participants	5 participants n=146 Participants	4 participants n=19 Participants	17 participants n=147 Participants
Region of Enrollment United Kingdom	0 participants n=39 Participants	1 participants n=41 Participants	0 participants n=35 Participants	0 participants n=31 Participants	0 participants n=146 Participants	1 participants n=19 Participants	2 participants n=147 Participants

PRIMARY outcome

Timeframe: baseline, 12 weeks

Population: Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.

LSMean adjusted for baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	0.5 mg LY2428757 n=34 Participants Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	2.0 mg LY2428757 n=34 Participants Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	6.2 mg LY2428757 n=39 Participants Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	12.0 mg LY2428757 n=32 Participants Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	17.6 mg LY2428757 n=35 Participants Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	Placebo n=32 Participants Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Change in Hemoglobin A1C (HbA1c) From Baseline to Week 12 Endpoint	-0.60 percentage of glycosylated hemoglobin Interval -0.87 to -0.34	-0.80 percentage of glycosylated hemoglobin Interval -1.05 to -0.55	-1.24 percentage of glycosylated hemoglobin Interval -1.49 to -1.0	-1.41 percentage of glycosylated hemoglobin Interval -1.67 to -1.15	-1.37 percentage of glycosylated hemoglobin Interval -1.62 to -1.11	-0.13 percentage of glycosylated hemoglobin Interval -0.39 to 0.13

SECONDARY outcome

Timeframe: baseline, 12 weeks

Population: Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.

The VAS scales for appetite (hunger) and satiety (how full) were recorded on a scale with range of possible scores from 0 to 100 represented in millimeters on a 10 centimeter line. For appetite, participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - not at all hungry and 10 - extremely hungry). For satiety, participant chooses where they think their satiety lies on a 10 centimeter line between two anchors (0 - not at all full and 10 - extremely full). LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	0.5 mg LY2428757 n=34 Participants Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	2.0 mg LY2428757 n=34 Participants Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	6.2 mg LY2428757 n=38 Participants Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	12.0 mg LY2428757 n=34 Participants Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	17.6 mg LY2428757 n=35 Participants Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	Placebo n=34 Participants Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Change in Visual Analogue Scales (VAS) For Appetite and Satiety From Baseline to Week 12 Endpoint Hunger	-2.28 millimeters (mm) Standard Error 3.05	-0.85 millimeters (mm) Standard Error 3.03	-3.76 millimeters (mm) Standard Error 2.88	-0.92 millimeters (mm) Standard Error 3.04	-1.37 millimeters (mm) Standard Error 3.00	-4.22 millimeters (mm) Standard Error 3.05
Change in Visual Analogue Scales (VAS) For Appetite and Satiety From Baseline to Week 12 Endpoint How Full	13.32 millimeters (mm) Standard Error 3.53	3.04 millimeters (mm) Standard Error 3.48	5.98 millimeters (mm) Standard Error 3.33	2.38 millimeters (mm) Standard Error 3.50	4.41 millimeters (mm) Standard Error 3.44	10.43 millimeters (mm) Standard Error 3.49

SECONDARY outcome

Timeframe: baseline through 16 weeks

Population: All randomized participants

Blood samples were collected from all randomized participants to test for the development of antibodies binding to LY2428757. If a participant developed a positive anti-LY2428757 antibody titer, appropriate medical management was to be utilized at the discretion of the sponsor and investigator, if deemed necessary.

Outcome measures

Outcome measures
Measure	0.5 mg LY2428757 n=36 Participants Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	2.0 mg LY2428757 n=43 Participants Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	6.2 mg LY2428757 n=42 Participants Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	12.0 mg LY2428757 n=42 Participants Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	17.6 mg LY2428757 n=43 Participants Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	Placebo n=41 Participants Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Number of Participants With Detectable Antibodies To LY2428757 At Any Time During The Study	1 participants	2 participants	1 participants	3 participants	2 participants	1 participants

SECONDARY outcome

Timeframe: 4 weeks, 6 weeks, 8 weeks, 10 weeks

Population: All randomized participants

Average concentration (Cavg) is calculated as the AUC0-168 (area under the plasma concentration vs. time curve during one dosing interval of 168 hours) divided by 168 hours. The numbers presented reflect the average LY2428757 drug concentration circulating in the body over 168 hours (one dosing interval).

Outcome measures

Outcome measures
Measure	0.5 mg LY2428757 n=34 Participants Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	2.0 mg LY2428757 n=34 Participants Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	6.2 mg LY2428757 n=39 Participants Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	12.0 mg LY2428757 n=32 Participants Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	17.6 mg LY2428757 n=35 Participants Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	Placebo n=32 Participants Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Total Average Concentration (Cavg) of LY2428757	29.5 nanograms per milliliter (ng/mL)	118 nanograms per milliliter (ng/mL)	453 nanograms per milliliter (ng/mL)	877 nanograms per milliliter (ng/mL)	1290 nanograms per milliliter (ng/mL)	0 nanograms per milliliter (ng/mL)

SECONDARY outcome

Timeframe: baseline, 12 weeks

Population: Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.

Self-monitored glucose levels measured at 7 timepoints during the day. Timepoints include: fasting pre-breakfast, 2 hours post breakfast, prior to lunch, 2 hours post lunch, prior to dinner, 2 hours post dinner, and prior to bed. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	0.5 mg LY2428757 n=30 Participants Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	2.0 mg LY2428757 n=29 Participants Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	6.2 mg LY2428757 n=36 Participants Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	12.0 mg LY2428757 n=30 Participants Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	17.6 mg LY2428757 n=31 Participants Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	Placebo n=29 Participants Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Change in 7-Point Self-Monitored Glucose From Baseline to Week 12 Endpoint Prior to Bed (n=27, 23, 33, 25, 29, 25)	-12.33 milligrams per deciliter (mg/dL) Interval -26.37 to 1.7	-24.08 milligrams per deciliter (mg/dL) Interval -38.94 to -9.23	-26.48 milligrams per deciliter (mg/dL) Interval -39.23 to -13.72	-29.05 milligrams per deciliter (mg/dL) Interval -43.33 to -14.78	-41.48 milligrams per deciliter (mg/dL) Interval -54.74 to -28.21	11.69 milligrams per deciliter (mg/dL) Interval -2.82 to 26.19
Change in 7-Point Self-Monitored Glucose From Baseline to Week 12 Endpoint Fasting	-2.14 milligrams per deciliter (mg/dL) Interval -11.15 to 6.87	-17.08 milligrams per deciliter (mg/dL) Interval -26.06 to -8.11	-30.13 milligrams per deciliter (mg/dL) Interval -38.41 to -21.84	-28.05 milligrams per deciliter (mg/dL) Interval -36.85 to -19.26	-32.85 milligrams per deciliter (mg/dL) Interval -41.51 to -24.2	2.39 milligrams per deciliter (mg/dL) Interval -6.67 to 11.46
Change in 7-Point Self-Monitored Glucose From Baseline to Week 12 Endpoint 2 Hours Post Breakfast (n=29, 28, 34,28 30,29)	-7.85 milligrams per deciliter (mg/dL) Interval -23.22 to 7.51	-32.25 milligrams per deciliter (mg/dL) Interval -47.54 to -16.97	-45.02 milligrams per deciliter (mg/dL) Interval -59.29 to -30.74	-45.58 milligrams per deciliter (mg/dL) Interval -60.9 to -30.26	-53.91 milligrams per deciliter (mg/dL) Interval -68.67 to -39.15	-2.53 milligrams per deciliter (mg/dL) Interval -17.77 to 12.71
Change in 7-Point Self-Monitored Glucose From Baseline to Week 12 Endpoint Prior to Lunch (n=29, 27, 34, 28, 29, 28)	-6.22 milligrams per deciliter (mg/dL) Interval -19.31 to 6.87	-7.92 milligrams per deciliter (mg/dL) Interval -21.17 to 5.33	-25.42 milligrams per deciliter (mg/dL) Interval -37.59 to -13.26	-22.09 milligrams per deciliter (mg/dL) Interval -35.2 to -8.98	-26.37 milligrams per deciliter (mg/dL) Interval -39.16 to -13.58	13.98 milligrams per deciliter (mg/dL) Interval 0.75 to 27.21
Change in 7-Point Self-Monitored Glucose From Baseline to Week 12 Endpoint 2 Hours Post Lunch (n=28, 27, 35, 28, 30, 29)	-17.71 milligrams per deciliter (mg/dL) Interval -31.16 to -4.26	-23.79 milligrams per deciliter (mg/dL) Interval -37.28 to -10.29	-44.43 milligrams per deciliter (mg/dL) Interval -56.57 to -32.29	-35.97 milligrams per deciliter (mg/dL) Interval -49.25 to -22.69	-54.77 milligrams per deciliter (mg/dL) Interval -67.64 to -41.9	-11.30 milligrams per deciliter (mg/dL) Interval -24.5 to 1.9
Change in 7-Point Self-Monitored Glucose From Baseline to Week 12 Endpoint Prior to Dinner (n=29, 27, 35, 28, 29, 29)	-24.25 milligrams per deciliter (mg/dL) Interval -36.63 to -11.86	-33.82 milligrams per deciliter (mg/dL) Interval -46.46 to -21.17	-38.10 milligrams per deciliter (mg/dL) Interval -49.37 to -26.83	-39.90 milligrams per deciliter (mg/dL) Interval -52.36 to -27.43	-45.82 milligrams per deciliter (mg/dL) Interval -58.04 to -33.59	0.45 milligrams per deciliter (mg/dL) Interval -11.87 to 12.76
Change in 7-Point Self-Monitored Glucose From Baseline to Week 12 Endpoint 2 Hours Post Dinner (n=29, 28, 35, 29, 29, 29)	-13.35 milligrams per deciliter (mg/dL) Interval -27.58 to 0.89	-22.63 milligrams per deciliter (mg/dL) Interval -37.07 to -8.2	-36.70 milligrams per deciliter (mg/dL) Interval -49.7 to -23.7	-31.10 milligrams per deciliter (mg/dL) Interval -45.23 to -16.97	-51.41 milligrams per deciliter (mg/dL) Interval -65.48 to -37.33	-1.51 milligrams per deciliter (mg/dL) Interval -15.69 to 12.68

SECONDARY outcome

Timeframe: baseline, 12 weeks

Population: Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.

An oral glucose tolerance test (OGTT) was used to assess changes in glucose tolerance. The area under the plasma glucose concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for glucose represents the area that is under the curve of glucose values when they are plotted over time. Larger AUC values represent a greater average glucose value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	0.5 mg LY2428757 n=30 Participants Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	2.0 mg LY2428757 n=28 Participants Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	6.2 mg LY2428757 n=35 Participants Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	12.0 mg LY2428757 n=27 Participants Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	17.6 mg LY2428757 n=32 Participants Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	Placebo n=29 Participants Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Change in Total Glucose Area Under the Curve (AUC) From Baseline to Week 12 Endpoint	-1370.49 milligrams per minute per deciliter Interval -3304.81 to 563.83	-1709.67 milligrams per minute per deciliter Interval -3710.31 to 290.96	-5786.59 milligrams per minute per deciliter Interval -7581.0 to -3992.17	-6354.83 milligrams per minute per deciliter Interval -8398.99 to -4310.66	-8025.33 milligrams per minute per deciliter Interval -9897.49 to -6153.17	-238.64 milligrams per minute per deciliter Interval -2204.37 to 1727.09

SECONDARY outcome

Timeframe: baseline, 12 weeks

Population: Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.

An oral glucose tolerance test (OGTT) was used to assess changes in insulin secretory response. The area under the insulin concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for insulin represents the area that is under the curve of insulin values when they are plotted over time. Larger AUC values represent a greater average insulin value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	0.5 mg LY2428757 n=23 Participants Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	2.0 mg LY2428757 n=23 Participants Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	6.2 mg LY2428757 n=32 Participants Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	12.0 mg LY2428757 n=23 Participants Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	17.6 mg LY2428757 n=27 Participants Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	Placebo n=27 Participants Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Change in Insulin Total Area Under the Curve (AUC) From Baseline to Week 12 Endpoint	3111.25 picomole per minute per liter Interval -4046.98 to 10269.49	3984.37 picomole per minute per liter Interval -3119.75 to 11088.5	12521.89 picomole per minute per liter Interval 6225.8 to 18817.99	14179.28 picomole per minute per liter Interval 6829.94 to 21528.62	8778.23 picomole per minute per liter Interval 2213.32 to 15343.14	3540.52 picomole per minute per liter Interval -3092.57 to 10173.62

SECONDARY outcome

Timeframe: baseline, 12 weeks

Population: Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.

An oral glucose tolerance test (OGTT) was used to assess changes in insulin secretory response. The area under the C-peptide concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for C-peptide represents the area that is under the curve of C-peptide values when they are plotted over time. Larger AUC values represent a greater average C-peptide value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	0.5 mg LY2428757 n=29 Participants Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	2.0 mg LY2428757 n=27 Participants Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	6.2 mg LY2428757 n=33 Participants Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	12.0 mg LY2428757 n=27 Participants Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	17.6 mg LY2428757 n=30 Participants Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	Placebo n=30 Participants Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Change in C-peptide Area Under the Curve (AUC) From Baseline to Week 12 Endpoint	-683.72 picomole per minute per liter Interval -27307.99 to 25940.55	31434.85 picomole per minute per liter Interval 4250.94 to 58618.75	49370.53 picomole per minute per liter Interval 24438.17 to 74302.88	46280.14 picomole per minute per liter Interval 18616.52 to 73943.75	22012.58 picomole per minute per liter Interval -3998.13 to 48023.29	8714.30 picomole per minute per liter Interval -17322.91 to 34751.5

SECONDARY outcome

Timeframe: baseline, 12 weeks

Population: Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement. The last post-baseline measurement was carried forward if the value at week 12 was missing.

Fasting lipids were measured after overnight fasting of at least 8 hours. Lipids analyzed include triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and total-cholesterol. LSMean adjusted for baseline and treatment.

Outcome measures

Outcome measures
Measure	0.5 mg LY2428757 n=35 Participants Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	2.0 mg LY2428757 n=40 Participants Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	6.2 mg LY2428757 n=40 Participants Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	12.0 mg LY2428757 n=37 Participants Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	17.6 mg LY2428757 n=41 Participants Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	Placebo n=37 Participants Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Change in Fasting Lipids From Baseline to Week 12 Endpoint Triglycerides (n=35, 40, 40, 37, 41, 37)	-0.15 millimole per liter (mmol/L) Standard Error 0.139	0.08 millimole per liter (mmol/L) Standard Error 0.130	-0.35 millimole per liter (mmol/L) Standard Error 0.130	-0.31 millimole per liter (mmol/L) Standard Error 0.135	-0.31 millimole per liter (mmol/L) Standard Error 0.128	-0.22 millimole per liter (mmol/L) Standard Error 0.135
Change in Fasting Lipids From Baseline to Week 12 Endpoint HDL (n=35, 38, 39, 31, 39, 34)	0.02 millimole per liter (mmol/L) Standard Error 0.034	-0.03 millimole per liter (mmol/L) Standard Error 0.032	-0.03 millimole per liter (mmol/L) Standard Error 0.032	-0.03 millimole per liter (mmol/L) Standard Error 0.036	0.02 millimole per liter (mmol/L) Standard Error 0.032	0.01 millimole per liter (mmol/L) Standard Error 0.034
Change in Fasting Lipids From Baseline to Week 12 Endpoint LDL (n=35, 37, 39, 31, 39, 34)	0.0 millimole per liter (mmol/L) Standard Error 0.09	-0.1 millimole per liter (mmol/L) Standard Error 0.09	-0.1 millimole per liter (mmol/L) Standard Error 0.09	0.0 millimole per liter (mmol/L) Standard Error 0.10	-0.1 millimole per liter (mmol/L) Standard Error 0.09	0.1 millimole per liter (mmol/L) Standard Error 0.09
Change in Fasting Lipids From Baseline to Week 12 Endpoint Total cholesterol (n=35, 38, 39, 31, 39, 34)	-0.10 millimole per liter (mmol/L) Standard Error 0.104	-0.01 millimole per liter (mmol/L) Standard Error 0.100	-0.30 millimole per liter (mmol/L) Standard Error 0.098	-0.10 millimole per liter (mmol/L) Standard Error 0.112	-0.25 millimole per liter (mmol/L) Standard Error 0.099	0.02 millimole per liter (mmol/L) Standard Error 0.105

SECONDARY outcome

Timeframe: baseline, 12 weeks

Population: Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.

LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	0.5 mg LY2428757 n=35 Participants Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	2.0 mg LY2428757 n=36 Participants Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	6.2 mg LY2428757 n=40 Participants Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	12.0 mg LY2428757 n=36 Participants Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	17.6 mg LY2428757 n=35 Participants Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	Placebo n=34 Participants Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Change in Fasting Weight From Baseline to Week 12 Endpoint	-0.75 kilograms (kg) Interval -1.63 to 0.13	-0.85 kilograms (kg) Interval -1.69 to -0.01	-2.12 kilograms (kg) Interval -2.94 to -1.3	-1.03 kilograms (kg) Interval -1.88 to -0.18	-2.60 kilograms (kg) Interval -3.46 to -1.75	-0.59 kilograms (kg) Interval -1.46 to 0.28

SECONDARY outcome

Timeframe: baseline, 12 weeks

Population: Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement, last observation carried forward (LOCF) up to visit 9 (week 12)

Impact of Weight on Quality of Life (IWQoL) - Lite Version consists of 31 items from 5 subscales: physical functioning, self-esteem, sexual life, public distress, and work as well as a total score. Individual item scoring ranges from 0 (never true) to 4 (always true) with total score range from 0 to 124. Higher scores on the subscales and total score correspond with lower levels of functioning or greater negative effect. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.

Outcome measures

Outcome measures
Measure	0.5 mg LY2428757 n=35 Participants Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	2.0 mg LY2428757 n=39 Participants Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	6.2 mg LY2428757 n=40 Participants Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	12.0 mg LY2428757 n=38 Participants Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	17.6 mg LY2428757 n=40 Participants Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	Placebo n=37 Participants Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Change in Impact of Weight on Quality of Life - Lite (IWQoL-Lite) Average Score From Baseline to Week 12 Endpoint	0.2 units on a scale Standard Error 0.22	-0.1 units on a scale Standard Error 0.20	0.3 units on a scale Standard Error 0.21	0.2 units on a scale Standard Error 0.21	0.1 units on a scale Standard Error 0.21	0.2 units on a scale Standard Error 0.21

SECONDARY outcome

Timeframe: baseline, 12 weeks

Population: Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement, last observation carried forward (LOCF) up to visit 9 (week 12)

DSC-R assesses the presence and perceived burden of diabetes-related symptoms using the following subscales: hypoglycemic, hyperglycemic, psychological, cardiovascular, neurological, ophthalmological. Participants evaluate symptoms based on a 5-point Likert-type scale, ranging from 1=not at all troublesome to 5=extremely troublesome. Higher scores indicated greater severity of symptoms within a domain, or poorer perceived health, respectively. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.

Outcome measures

Outcome measures
Measure	0.5 mg LY2428757 n=35 Participants Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	2.0 mg LY2428757 n=39 Participants Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	6.2 mg LY2428757 n=40 Participants Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	12.0 mg LY2428757 n=37 Participants Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	17.6 mg LY2428757 n=40 Participants Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	Placebo n=38 Participants Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Change in Diabetes Symptom Checklist-Revised (DSC-R) Average Score From Baseline to Week 12 Endpoint	-0.3 units on a scale Standard Error 0.30	-0.1 units on a scale Standard Error 0.28	-0.9 units on a scale Standard Error 0.28	-0.4 units on a scale Standard Error 0.29	-0.3 units on a scale Standard Error 0.29	-0.7 units on a scale Standard Error 0.28

SECONDARY outcome

Timeframe: baseline, 12 weeks

Population: Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement, last observation carried forward (LOCF) up to visit 9 (week 12)

Participant chooses where they think their current health state lies on a 10 centimeter line between two anchors (0 - worst imaginable health state and 10 - best imaginable health state). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line. A higher score is associated with better health state. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.

Outcome measures

Outcome measures
Measure	0.5 mg LY2428757 n=35 Participants Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	2.0 mg LY2428757 n=39 Participants Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	6.2 mg LY2428757 n=40 Participants Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	12.0 mg LY2428757 n=38 Participants Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	17.6 mg LY2428757 n=40 Participants Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	Placebo n=37 Participants Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Change in European Quality of Life (EuroQol)- Visual Analog Scale From Baseline to Week 12 Endpoint	6.9 millimeters Standard Error 2.59	6.2 millimeters Standard Error 2.33	6.0 millimeters Standard Error 2.41	6.0 millimeters Standard Error 2.46	7.1 millimeters Standard Error 2.47	2.7 millimeters Standard Error 2.48

SECONDARY outcome

Timeframe: Baseline, 12 Weeks

The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each participant, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.

Outcome measures

Outcome measures
Measure	0.5 mg LY2428757 n=36 Participants Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	2.0 mg LY2428757 n=42 Participants Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	6.2 mg LY2428757 n=42 Participants Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	12.0 mg LY2428757 n=39 Participants Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	17.6 mg LY2428757 n=42 Participants Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	Placebo n=40 Participants Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint Mobility-Baseline	88.9 percentage of participants	73.8 percentage of participants	76.2 percentage of participants	84.6 percentage of participants	81.0 percentage of participants	75.0 percentage of participants
Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint Mobility-Endpoint	94.3 percentage of participants	77.8 percentage of participants	90.0 percentage of participants	77.8 percentage of participants	88.6 percentage of participants	85.3 percentage of participants
Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint Self Care-Baseline	97.2 percentage of participants	97.6 percentage of participants	90.5 percentage of participants	94.9 percentage of participants	95.2 percentage of participants	97.5 percentage of participants
Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint Self Care- Endpoint	94.3 percentage of participants	97.2 percentage of participants	100.0 percentage of participants	94.4 percentage of participants	100.0 percentage of participants	97.1 percentage of participants
Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint Usual Activities- Baseline	80.6 percentage of participants	81.0 percentage of participants	83.3 percentage of participants	87.2 percentage of participants	81.0 percentage of participants	75.0 percentage of participants
Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint Usual Activities- Endpoint	91.4 percentage of participants	88.9 percentage of participants	90.0 percentage of participants	91.7 percentage of participants	97.1 percentage of participants	88.2 percentage of participants
Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint Pain/Discomfort- Baseline	61.1 percentage of participants	59.5 percentage of participants	54.8 percentage of participants	59.0 percentage of participants	54.8 percentage of participants	52.5 percentage of participants
Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint Pain/Discomfort- Endpoint	60.0 percentage of participants	52.8 percentage of participants	70.0 percentage of participants	63.9 percentage of participants	71.4 percentage of participants	61.8 percentage of participants
Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint Anxiety/Depression- Baseline	66.7 percentage of participants	64.3 percentage of participants	73.8 percentage of participants	74.4 percentage of participants	66.7 percentage of participants	70.0 percentage of participants
Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint Anxiety/Depression- Endpoint	68.6 percentage of participants	69.4 percentage of participants	87.5 percentage of participants	77.8 percentage of participants	74.3 percentage of participants	70.6 percentage of participants

Adverse Events

0.5 mg LY2428757

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

2.0 mg LY2428757

Serious events: 4 serious events

Other events: 25 other events

Deaths: 0 deaths

6.2 mg LY2428757

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

12.0 mg LY2428757

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

17.6 mg LY2428757

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	0.5 mg LY2428757 n=36 participants at risk Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	2.0 mg LY2428757 n=42 participants at risk Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	6.2 mg LY2428757 n=42 participants at risk Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	12.0 mg LY2428757 n=41 participants at risk Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	17.6 mg LY2428757 n=43 participants at risk Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	Placebo n=40 participants at risk Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Cardiac disorders Acute myocardial infarction	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Cardiac disorders Atrial fibrillation	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Crohn's disease	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Infections and infestations Urinary tract infection	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Metabolism and nutrition disorders Hypoglycaemia	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.

Other adverse events

Other adverse events
Measure	0.5 mg LY2428757 n=36 participants at risk Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	2.0 mg LY2428757 n=42 participants at risk Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	6.2 mg LY2428757 n=42 participants at risk Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	12.0 mg LY2428757 n=41 participants at risk Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	17.6 mg LY2428757 n=43 participants at risk Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.	Placebo n=40 participants at risk Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Blood and lymphatic system disorders Anaemia	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Cardiac disorders Angina pectoris	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Cardiac disorders Atrial fibrillation	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Cardiac disorders Atrioventricular block first degree	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Cardiac disorders Myocardial ischaemia	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Cardiac disorders Ventricular extrasystoles	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Ear and labyrinth disorders Ear pain	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Ear and labyrinth disorders Tympanic membrane disorder	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
Ear and labyrinth disorders Vertigo	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	4.9% 2/41 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Eye disorders Conjunctivitis	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Eye disorders Conjunctivitis allergic	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Eye disorders Vision blurred	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	5.0% 2/40 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.
Eye disorders Visual acuity reduced	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Eye disorders Visual disturbance	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Abdominal distension	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	4.7% 2/43 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Abdominal pain	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	4.8% 2/42 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	4.7% 2/43 • Number of events 3 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Abdominal rigidity	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	4.9% 2/41 • Number of events 3 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Constipation	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	4.8% 2/42 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	4.9% 2/41 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	11.6% 5/43 • Number of events 7 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Crohn's disease	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Diarrhoea	8.3% 3/36 • Number of events 3 The safety population includes all randomized participants who received at least one administration of study medication.	7.1% 3/42 • Number of events 3 The safety population includes all randomized participants who received at least one administration of study medication.	9.5% 4/42 • Number of events 7 The safety population includes all randomized participants who received at least one administration of study medication.	17.1% 7/41 • Number of events 9 The safety population includes all randomized participants who received at least one administration of study medication.	7.0% 3/43 • Number of events 4 The safety population includes all randomized participants who received at least one administration of study medication.	7.5% 3/40 • Number of events 6 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Dry mouth	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Dyspepsia	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	7.1% 3/42 • Number of events 5 The safety population includes all randomized participants who received at least one administration of study medication.	7.3% 3/41 • Number of events 5 The safety population includes all randomized participants who received at least one administration of study medication.	14.0% 6/43 • Number of events 9 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Eructation	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	4.9% 2/41 • Number of events 3 The safety population includes all randomized participants who received at least one administration of study medication.	4.7% 2/43 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Flatulence	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Food poisoning	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Gastritis	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	4.7% 2/43 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Nausea	2.8% 1/36 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	14.3% 6/42 • Number of events 6 The safety population includes all randomized participants who received at least one administration of study medication.	21.4% 9/42 • Number of events 21 The safety population includes all randomized participants who received at least one administration of study medication.	31.7% 13/41 • Number of events 18 The safety population includes all randomized participants who received at least one administration of study medication.	37.2% 16/43 • Number of events 29 The safety population includes all randomized participants who received at least one administration of study medication.	15.0% 6/40 • Number of events 6 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Toothache	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Gastrointestinal disorders Vomiting	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	9.8% 4/41 • Number of events 4 The safety population includes all randomized participants who received at least one administration of study medication.	16.3% 7/43 • Number of events 12 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
General disorders Asthenia	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.
General disorders Chest pain	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
General disorders Cyst rupture	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
General disorders Early satiety	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
General disorders Fatigue	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	4.7% 2/43 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
General disorders Injection site bruising	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 3 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
General disorders Injection site haematoma	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
General disorders Injection site irritation	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 3 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
General disorders Injection site pain	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	5.0% 2/40 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.
General disorders Injection site pruritus	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
General disorders Injection site reaction	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
General disorders Local swelling	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
General disorders Malaise	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
General disorders Oedema peripheral	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
General disorders Pyrexia	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
General disorders Thirst	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
General disorders Vessel puncture site haematoma	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Immune system disorders Seasonal allergy	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
Infections and infestations Bronchitis	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
Infections and infestations Cellulitis	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Infections and infestations Diverticulitis	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Infections and infestations Ear infection	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Infections and infestations Gastroenteritis	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Infections and infestations Herpes zoster	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
Infections and infestations Influenza	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Infections and infestations Nasopharyngitis	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	4.8% 2/42 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	4.9% 2/41 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Infections and infestations Oral herpes	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Infections and infestations Pharyngitis	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Infections and infestations Pharyngotonsillitis	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Infections and infestations Rash pustular	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
Infections and infestations Respiratory tract infection viral	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	4.8% 2/42 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Infections and infestations Rhinitis	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Infections and infestations Sinusitis	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Infections and infestations Tonsillitis	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Infections and infestations Upper respiratory tract infection	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Infections and infestations Urinary tract infection	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	4.8% 2/42 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
Injury, poisoning and procedural complications Contusion	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
Injury, poisoning and procedural complications Limb injury	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Injury, poisoning and procedural complications Skin laceration	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Injury, poisoning and procedural complications Wound	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Investigations Alanine aminotransferase increased	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
Investigations Aspartate aminotransferase increased	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
Investigations Blood calcitonin increased	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Investigations Blood calcium increased	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Investigations Blood creatine phosphokinase increased	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
Investigations Blood creatinine increased	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Investigations Blood glucose increased	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Investigations Blood pressure increased	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Investigations Blood triglycerides increased	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Investigations Blood urine present	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Investigations Electrocardiogram qt prolonged	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
Investigations Gamma-glutamyltransferase increased	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Investigations Haematocrit decreased	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Investigations Haemoglobin decreased	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Investigations Lipase increased	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	4.7% 2/43 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Investigations Protein urine	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Metabolism and nutrition disorders Anorexia	2.8% 1/36 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	4.8% 2/42 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	7.5% 3/40 • Number of events 3 The safety population includes all randomized participants who received at least one administration of study medication.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	4.8% 2/42 • Number of events 3 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	4.7% 2/43 • Number of events 4 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Metabolism and nutrition disorders Hypertriglyceridaemia	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	4.9% 2/41 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 2/36 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	4.8% 2/42 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	7.1% 3/42 • Number of events 3 The safety population includes all randomized participants who received at least one administration of study medication.	4.8% 2/42 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Musculoskeletal and connective tissue disorders Joint swelling	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Musculoskeletal and connective tissue disorders Muscle spasms	5.6% 2/36 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	4.7% 2/43 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	4.8% 2/42 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Musculoskeletal and connective tissue disorders Tenosynovitis	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Nervous system disorders Burning sensation	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Nervous system disorders Dizziness	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	4.8% 2/42 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	4.9% 2/41 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	4.7% 2/43 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	5.0% 2/40 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.
Nervous system disorders Dysgeusia	2.8% 1/36 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Nervous system disorders Headache	5.6% 2/36 • Number of events 3 The safety population includes all randomized participants who received at least one administration of study medication.	7.1% 3/42 • Number of events 5 The safety population includes all randomized participants who received at least one administration of study medication.	4.8% 2/42 • Number of events 3 The safety population includes all randomized participants who received at least one administration of study medication.	12.2% 5/41 • Number of events 5 The safety population includes all randomized participants who received at least one administration of study medication.	9.3% 4/43 • Number of events 4 The safety population includes all randomized participants who received at least one administration of study medication.	5.0% 2/40 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.
Nervous system disorders Hypoaesthesia	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Nervous system disorders Lethargy	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Nervous system disorders Neuritis	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Nervous system disorders Paraesthesia	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Nervous system disorders Polyneuropathy	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
Nervous system disorders Sciatica	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Nervous system disorders Somnolence	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
Nervous system disorders Syncope	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Nervous system disorders Syncope vasovagal	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Nervous system disorders Tremor	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	4.8% 2/42 • Number of events 4 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Psychiatric disorders Depression	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
Psychiatric disorders Insomnia	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Renal and urinary disorders Dysuria	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Renal and urinary disorders Haematuria	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Renal and urinary disorders Nocturia	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Renal and urinary disorders Renal pain	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	2.5% 1/40 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.
Reproductive system and breast disorders Pelvic pain	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Reproductive system and breast disorders Uterine cyst	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	5.0% 2/40 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.
Respiratory, thoracic and mediastinal disorders Cough	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	5.0% 2/40 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Skin and subcutaneous tissue disorders Dandruff	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Skin and subcutaneous tissue disorders Dermatitis contact	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Skin and subcutaneous tissue disorders Dermatosis	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Skin and subcutaneous tissue disorders Ingrowing nail	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Skin and subcutaneous tissue disorders Pruritus	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Skin and subcutaneous tissue disorders Rash	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Vascular disorders Circulatory collapse	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/41 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Vascular disorders Haematoma	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Vascular disorders Hot flush	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Vascular disorders Hypertension	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	11.9% 5/42 • Number of events 6 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	4.9% 2/41 • Number of events 2 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Vascular disorders Hypotension	0.00% 0/36 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	2.4% 1/42 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/43 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.
Vascular disorders Orthostatic hypotension	2.8% 1/36 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/42 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/41 The safety population includes all randomized participants who received at least one administration of study medication.	2.3% 1/43 • Number of events 1 The safety population includes all randomized participants who received at least one administration of study medication.	0.00% 0/40 The safety population includes all randomized participants who received at least one administration of study medication.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60