Trial Outcomes & Findings for A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes (NCT NCT06010004)

Last Updated: 2026-06-30

Results Overview

A TEAE was defined as any adverse event that began on or after the first dose of study drug or began before the first dose of study drug and worsened on or after the first dose of study drug.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

401 participants

Primary outcome timeframe

Baseline to Week 54

Results posted on

2026-06-30

Participant Flow

Participant milestones

Participant milestones
Measure	3 mg Orforglipron Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.	12 mg Orforglipron Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.	36 mg Orforglipron Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.
Overall Study STARTED	132	135	134
Overall Study Received at Least One Dose of Study Drug	132	135	134
Overall Study COMPLETED	125	128	125
Overall Study NOT COMPLETED	7	7	9

Reasons for withdrawal

Reasons for withdrawal
Measure	3 mg Orforglipron Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.	12 mg Orforglipron Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.	36 mg Orforglipron Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.
Overall Study Adverse Event	2	6	3
Overall Study Death	0	0	1
Overall Study Lost to Follow-up	1	0	0
Overall Study Withdrawal by Subject	4	1	5

Baseline Characteristics

A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	3 mg Orforglipron n=132 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.	12 mg Orforglipron n=135 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.	36 mg Orforglipron n=134 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.	Total n=401 Participants Total of all reporting groups
Age, Continuous	59.9 years STANDARD_DEVIATION 10.3 • n=20 Participants	58.5 years STANDARD_DEVIATION 11.0 • n=20 Participants	57.5 years STANDARD_DEVIATION 10.7 • n=40 Participants	58.6 years STANDARD_DEVIATION 10.7 • n=6 Participants
Sex: Female, Male Female	39 Participants n=20 Participants	38 Participants n=20 Participants	41 Participants n=40 Participants	118 Participants n=6 Participants
Sex: Female, Male Male	93 Participants n=20 Participants	97 Participants n=20 Participants	93 Participants n=40 Participants	283 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	132 Participants n=20 Participants	135 Participants n=20 Participants	134 Participants n=40 Participants	401 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Asian	132 Participants n=20 Participants	135 Participants n=20 Participants	134 Participants n=40 Participants	401 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants
Race (NIH/OMB) White	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants
Region of Enrollment Japan	132 Participants n=20 Participants	135 Participants n=20 Participants	134 Participants n=40 Participants	401 Participants n=6 Participants

PRIMARY outcome

Timeframe: Baseline to Week 54

Population: All participants who were randomized and received at least one dose of the study drug.

A TEAE was defined as any adverse event that began on or after the first dose of study drug or began before the first dose of study drug and worsened on or after the first dose of study drug.

Outcome measures

Outcome measures
Measure	12 mg Orforglipron n=135 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.	3 mg Orforglipron n=132 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.	36 mg Orforglipron n=134 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	114 Participants	107 Participants	118 Participants

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: All participants who were randomized and had non-missing HbA1c values at baseline and week 52.

HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.

Outcome measures

Outcome measures
Measure	12 mg Orforglipron n=128 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.	3 mg Orforglipron n=125 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.	36 mg Orforglipron n=125 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.
Change From Baseline in Hemoglobin A1c (HbA1c)	-1.97 percentage of HbA1c Standard Error 0.075	-1.71 percentage of HbA1c Standard Error 0.072	-2.13 percentage of HbA1c Standard Error 0.073

SECONDARY outcome

Timeframe: Week 52

Population: All participants who were randomized and had non-missing HbA1c values at baseline and week 52.

HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.

Outcome measures

Outcome measures
Measure	12 mg Orforglipron n=128 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.	3 mg Orforglipron n=125 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.	36 mg Orforglipron n=125 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.
Percentage of Participants Who Achieved HbA1c <7.0%	86.11 percentage of participants Standard Error 2.86	82.73 percentage of participants Standard Error 3.25	90.82 percentage of participants Standard Error 2.52

SECONDARY outcome

Timeframe: Week 52

Population: All participants who were randomized and had non-missing HbA1c values at baseline and week 52.

Outcome measures

Outcome measures
Measure	12 mg Orforglipron n=128 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.	3 mg Orforglipron n=125 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.	36 mg Orforglipron n=125 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.
Percentage of Participants Who Achieved HbA1c ≤6.5%	76.23 percentage of participants Standard Error 3.57	62.64 percentage of participants Standard Error 4.11	84.56 percentage of participants Standard Error 3.27

SECONDARY outcome

Timeframe: Week 52

Population: All participants who were randomized and had non-missing HbA1c values at baseline and week 52.

Outcome measures

Outcome measures
Measure	12 mg Orforglipron n=128 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.	3 mg Orforglipron n=125 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.	36 mg Orforglipron n=125 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.
Percentage of Participants Who Achieved HbA1c <5.7%	21.92 percentage of participants Standard Error 3.54	7.70 percentage of participants Standard Error 2.20	30.51 percentage of participants Standard Error 3.86

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: All participants who were randomized and had non-missing fasting serum glucose values at baseline and week 52.

Outcome measures

Outcome measures
Measure	12 mg Orforglipron n=128 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.	3 mg Orforglipron n=125 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.	36 mg Orforglipron n=124 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.
Change From Baseline in Fasting Serum Glucose	-55.1 milligrams per deciliter (mg/dL) Standard Error 2.86	-51.7 milligrams per deciliter (mg/dL) Standard Error 1.40	-64.5 milligrams per deciliter (mg/dL) Standard Error 1.37

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: All participants who were randomized and had non-missing body weight values at baseline and week 52.

Outcome measures

Outcome measures
Measure	12 mg Orforglipron n=127 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.	3 mg Orforglipron n=125 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.	36 mg Orforglipron n=125 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.
Change From Baseline in Body Weight	-5.08 kilogram (kg) Standard Error 0.474	-1.81 kilogram (kg) Standard Error 0.307	-6.75 kilogram (kg) Standard Error 0.509

SECONDARY outcome

Timeframe: Week 52

Population: All participants who were randomized and had non-missing body weight values at baseline and week 52.

The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.

Outcome measures

Outcome measures
Measure	12 mg Orforglipron n=127 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.	3 mg Orforglipron n=125 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.	36 mg Orforglipron n=125 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.
Percentage of Participants Who Achieved Weight Loss of ≥5% From Baseline	49.52 percentage of participants Standard Error 4.40	27.00 percentage of participants Standard Error 3.90	65.14 percentage of participants Standard Error 4.24

SECONDARY outcome

Timeframe: Week 52

Population: All participants who were randomized and had non-missing body weight values at baseline and week 52.

Outcome measures

Outcome measures
Measure	12 mg Orforglipron n=127 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.	3 mg Orforglipron n=125 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.	36 mg Orforglipron n=125 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.
Percentage of Participants Who Achieved Weight Loss of ≥10% From Baseline	24.68 percentage of participants Standard Error 3.78	10.11 percentage of participants Standard Error 2.66	37.91 percentage of participants Standard Error 4.30

SECONDARY outcome

Timeframe: Week 52

Population: All participants who were randomized and had non-missing body weight values at baseline and week 52.

Outcome measures

Outcome measures
Measure	12 mg Orforglipron n=127 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.	3 mg Orforglipron n=125 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.	36 mg Orforglipron n=125 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.
Percentage of Participants Who Achieved Weight Loss of ≥15% From Baseline	13.96 percentage of participants Standard Error 3.07	2.79 percentage of participants Standard Error 1.46	20.94 percentage of participants Standard Error 3.66

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: All participants who were randomized and had non-missing waist circumference values at baseline and week 52.

Outcome measures

Outcome measures
Measure	12 mg Orforglipron n=120 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.	3 mg Orforglipron n=120 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.	36 mg Orforglipron n=110 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.
Change From Baseline in Waist Circumference	-4.6 centimeter (cm) Standard Error 0.49	-2.4 centimeter (cm) Standard Error 0.43	-6.5 centimeter (cm) Standard Error 0.54

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: All participants who were randomized and had non-missing BMI values at baseline and week 52.

Outcome measures

Outcome measures
Measure	12 mg Orforglipron n=120 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.	3 mg Orforglipron n=120 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.	36 mg Orforglipron n=110 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.
Change From Baseline in Body Mass Index (BMI)	-1.9 kilogram per square meter (kg/m^2) Standard Error 0.17	-0.7 kilogram per square meter (kg/m^2) Standard Error 0.12	-2.5 kilogram per square meter (kg/m^2) Standard Error 0.19

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: All participants who were randomized and had non-missing 7-Point SMBG values at baseline and week 52.

SMBG is measured using a glucometer. The SMBG profiles will consist of the following 7-point measurements obtained on a single day: * before 3 main meals, * approximately 2 hours after 3 main meals, and * at bedtime Daily average glucose was calculated as the mean of 7 time point specific averages obtained from up to 2 non-consecutive SMBG profiles within week 52.

Outcome measures

Outcome measures
Measure	12 mg Orforglipron n=126 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.	3 mg Orforglipron n=122 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.	36 mg Orforglipron n=123 Participants Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.
Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)	-73.14 mg/dL Standard Deviation 41.064	-66.32 mg/dL Standard Deviation 40.622	-82.27 mg/dL Standard Deviation 39.367

Adverse Events

3 mg Orforglipron

Serious events: 4 serious events

Other events: 106 other events

Deaths: 0 deaths

12 mg Orforglipron

Serious events: 3 serious events

Other events: 114 other events

Deaths: 0 deaths

36 mg Orforglipron

Serious events: 6 serious events

Other events: 118 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	3 mg Orforglipron n=132 participants at risk Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.	12 mg Orforglipron n=135 participants at risk Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.	36 mg Orforglipron n=134 participants at risk Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.
Cardiac disorders Atrial fibrillation	0.00% 0/132 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.74% 1/135 • Number of events 1 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.00% 0/134 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.
Cardiac disorders Cardiac failure	0.00% 0/132 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.74% 1/135 • Number of events 1 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.00% 0/134 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.
Hepatobiliary disorders Cholecystocholangitis	0.00% 0/132 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.00% 0/135 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.75% 1/134 • Number of events 1 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.
Infections and infestations Enterocolitis bacterial	0.00% 0/132 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.00% 0/135 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.75% 1/134 • Number of events 1 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.
Infections and infestations Periodontitis	0.76% 1/132 • Number of events 1 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.00% 0/135 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.00% 0/134 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/132 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.00% 0/135 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.75% 1/134 • Number of events 1 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/132 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.74% 1/135 • Number of events 1 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.00% 0/134 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.
Metabolism and nutrition disorders Dehydration	0.00% 0/132 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.00% 0/135 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.75% 1/134 • Number of events 1 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.76% 1/132 • Number of events 1 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.00% 0/135 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.00% 0/134 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.76% 1/132 • Number of events 1 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.00% 0/135 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.00% 0/134 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.76% 1/132 • Number of events 1 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.00% 0/135 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.00% 0/134 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/93 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.00% 0/97 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	1.1% 1/93 • Number of events 1 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.
Psychiatric disorders Persistent depressive disorder	0.00% 0/132 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.00% 0/135 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.75% 1/134 • Number of events 1 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.
Vascular disorders Aortic stenosis	0.76% 1/132 • Number of events 1 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.00% 0/135 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.	0.00% 0/134 • Baseline to Week 54 * All participants who were randomized and received at least one dose of the study drug. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. * All the adverse events were recorded as per the planned treatment regimen.

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60