Trial Outcomes & Findings for A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes (NCT NCT03322631)
NCT ID: NCT03322631
Last Updated: 2023-03-23
Results Overview
Safety was assessed from time of consent through end of study (up to 85 days). Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Baseline through Day 85
Results posted on
2023-03-23
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo administered into the SC tissue of the abdominal wall.
|
2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)
Participants received tirzepatide with titration regimen starting from 2.5 mg (milligrams) for Days 1 and 8 followed by 5 mg for Days 15 and 22, and 10 mg for Days 29, 36, 43, and 50 administered into the subcutaneous (SC) tissue of the abdominal wall.
|
5 mg/10 mg/15 mg Tirzepatide (Cohort 2)
Participants received tirzepatide with titration regimen starting from 5 mg for Days 1 and 8 followed by 10 mg for Days 15, 22, 29, and 36, and 15 mg for Days 43 and 50 administered into the SC tissue of the abdominal wall.
|
5 mg Tirzepatide (Cohort 3)
Participants received 5 mg tirzepatide administered into the SC tissue of the abdominal wall.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
12
|
16
|
11
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
9
|
12
|
16
|
11
|
|
Overall Study
COMPLETED
|
9
|
11
|
15
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo administered into the SC tissue of the abdominal wall.
|
2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)
Participants received tirzepatide with titration regimen starting from 2.5 mg (milligrams) for Days 1 and 8 followed by 5 mg for Days 15 and 22, and 10 mg for Days 29, 36, 43, and 50 administered into the subcutaneous (SC) tissue of the abdominal wall.
|
5 mg/10 mg/15 mg Tirzepatide (Cohort 2)
Participants received tirzepatide with titration regimen starting from 5 mg for Days 1 and 8 followed by 10 mg for Days 15, 22, 29, and 36, and 15 mg for Days 43 and 50 administered into the SC tissue of the abdominal wall.
|
5 mg Tirzepatide (Cohort 3)
Participants received 5 mg tirzepatide administered into the SC tissue of the abdominal wall.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo
n=9 Participants
Participants received placebo administered into the subcutaneous (SC) tissue of the abdominal wall.
|
2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)
n=12 Participants
Participants received tirzepatide with titration regimen starting from 2.5 mg (milligrams) for Days 1 and 8 followed by 5 mg for Days 15 and 22, and 10 mg for Days 29, 36, 43, and 50 administered into the SC tissue of the abdominal wall.
|
5 mg/10 mg/15 mg Tirzepatide (Cohort 2)
n=16 Participants
Participants received tirzepatide with titration regimen starting from 5 mg for Days 1 and 8 followed by 10 mg for Days 15, 22, 29, and 36, and 15 mg for Days 43 and 50 administered into the SC tissue of the abdominal wall.
|
5 mg Tirzepatide (Cohort 3)
n=11 Participants
Participants received 5 mg tirzepatide administered into the SC tissue of the abdominal wall.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57.4 Years
STANDARD_DEVIATION 11.6 • n=99 Participants
|
56.9 Years
STANDARD_DEVIATION 9.5 • n=107 Participants
|
57.7 Years
STANDARD_DEVIATION 8.0 • n=206 Participants
|
57.5 Years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
57.4 Years
STANDARD_DEVIATION 8.8 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
47 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
48 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
48 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
Japan
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
48 Participants
n=31 Participants
|
|
Body Mass Index (BMI)
|
22.58 kg/m²
STANDARD_DEVIATION 2.09 • n=99 Participants
|
25.49 kg/m²
STANDARD_DEVIATION 2.75 • n=107 Participants
|
26.10 kg/m²
STANDARD_DEVIATION 3.11 • n=206 Participants
|
26.68 kg/m²
STANDARD_DEVIATION 3.29 • n=7 Participants
|
25.42 kg/m²
STANDARD_DEVIATION 3.16 • n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 85Population: All randomized participants who received at least one dose of study drug.
Safety was assessed from time of consent through end of study (up to 85 days). Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants received placebo administered into the SC tissue of the abdominal wall.
|
2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)
n=12 Participants
Participants received tirzepatide with titration regimen starting from 2.5 mg (milligrams) for Days 1 and 8 followed by 5 mg for Days 15 and 22, and 10 mg for Days 29, 36, 43, and 50 administered into the subcutaneous (SC) tissue of the abdominal wall.
|
5 mg/10 mg/15 mg Tirzepatide (Cohort 2)
n=16 Participants
Participants received tirzepatide with titration regimen starting from 5 mg for Days 1 and 8 followed by 10 mg for Days 15, 22, 29, and 36, and 15 mg for Days 43 and 50 administered into the SC tissue of the abdominal wall.
|
5 mg Tirzepatide (Cohort 3)
n=11 Participants
Participants received 5 mg tirzepatide administered into the SC tissue of the abdominal wall.
|
|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administrationPopulation: All randomized participants who received at least one dose of study drug and have evaluable PK data.
Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of Tirzepatide in plasma.
Outcome measures
| Measure |
Placebo
n=11 Participants
Participants received placebo administered into the SC tissue of the abdominal wall.
|
2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)
n=12 Participants
Participants received tirzepatide with titration regimen starting from 2.5 mg (milligrams) for Days 1 and 8 followed by 5 mg for Days 15 and 22, and 10 mg for Days 29, 36, 43, and 50 administered into the subcutaneous (SC) tissue of the abdominal wall.
|
5 mg/10 mg/15 mg Tirzepatide (Cohort 2)
n=11 Participants
Participants received tirzepatide with titration regimen starting from 5 mg for Days 1 and 8 followed by 10 mg for Days 15, 22, 29, and 36, and 15 mg for Days 43 and 50 administered into the SC tissue of the abdominal wall.
|
5 mg Tirzepatide (Cohort 3)
Participants received 5 mg tirzepatide administered into the SC tissue of the abdominal wall.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Tirzepatide
Day 1
|
215 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 18
|
442 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 23
|
364 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 20
|
—
|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Tirzepatide
Day 50
|
1520 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 15
|
2270 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 17
|
838 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 22
|
—
|
SECONDARY outcome
Timeframe: Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administrationPopulation: All randomized participants who received at least one dose of study drug and have evaluable PK data.
Area under the concentration versus time curve from time zero to tau (τ) of Tirzepatide (AUC\[0- τ\]), where tau is dosing interval of (0-168 hours).
Outcome measures
| Measure |
Placebo
n=11 Participants
Participants received placebo administered into the SC tissue of the abdominal wall.
|
2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)
n=12 Participants
Participants received tirzepatide with titration regimen starting from 2.5 mg (milligrams) for Days 1 and 8 followed by 5 mg for Days 15 and 22, and 10 mg for Days 29, 36, 43, and 50 administered into the subcutaneous (SC) tissue of the abdominal wall.
|
5 mg/10 mg/15 mg Tirzepatide (Cohort 2)
n=11 Participants
Participants received tirzepatide with titration regimen starting from 5 mg for Days 1 and 8 followed by 10 mg for Days 15, 22, 29, and 36, and 15 mg for Days 43 and 50 administered into the SC tissue of the abdominal wall.
|
5 mg Tirzepatide (Cohort 3)
Participants received 5 mg tirzepatide administered into the SC tissue of the abdominal wall.
|
|---|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide
Day 1
|
26100 nanograms * hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 27
|
54400 nanograms * hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 16
|
48800 nanograms * hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 16
|
—
|
|
PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide
Day 50
|
192000 nanograms * hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 16
|
285000 nanograms * hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 15
|
104000 nanograms * hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 19
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: All randomized participants who received at least one dose of drug and have evaluable PK data.
Change from baseline to 8 weeks in Fasting Plasma Glucose was measured to investigate the PD effect of Tirzepatide after multiple SC doses administered to Japanese patients with T2DM
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants received placebo administered into the SC tissue of the abdominal wall.
|
2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)
n=11 Participants
Participants received tirzepatide with titration regimen starting from 2.5 mg (milligrams) for Days 1 and 8 followed by 5 mg for Days 15 and 22, and 10 mg for Days 29, 36, 43, and 50 administered into the subcutaneous (SC) tissue of the abdominal wall.
|
5 mg/10 mg/15 mg Tirzepatide (Cohort 2)
n=15 Participants
Participants received tirzepatide with titration regimen starting from 5 mg for Days 1 and 8 followed by 10 mg for Days 15, 22, 29, and 36, and 15 mg for Days 43 and 50 administered into the SC tissue of the abdominal wall.
|
5 mg Tirzepatide (Cohort 3)
n=11 Participants
Participants received 5 mg tirzepatide administered into the SC tissue of the abdominal wall.
|
|---|---|---|---|---|
|
Pharmacodynamics (PD): Change From Baseline to 8 Weeks in Fasting Plasma Glucose
|
-4.0 milligram per deciliter (mg/dL)
Standard Deviation 23.7
|
-77.5 milligram per deciliter (mg/dL)
Standard Deviation 24.2
|
-72.6 milligram per deciliter (mg/dL)
Standard Deviation 30.9
|
-51.7 milligram per deciliter (mg/dL)
Standard Deviation 28.9
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
5 mg/10 mg/15 mg Tirzepatide (Cohort 2)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
5 mg Tirzepatide (Cohort 3)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=9 participants at risk
Participants received placebo administered into the SC tissue of the abdominal wall.
|
2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)
n=12 participants at risk
Participants received tirzepatide with titration regimen starting from 2.5 mg (milligrams) for Days 1 and 8 followed by 5 mg for Days 15 and 22, and 10 mg for Days 29, 36, 43, and 50 administered into the subcutaneous (SC) tissue of the abdominal wall.
|
5 mg/10 mg/15 mg Tirzepatide (Cohort 2)
n=16 participants at risk
Participants received tirzepatide with titration regimen starting from 5 mg for Days 1 and 8 followed by 10 mg for Days 15, 22, 29, and 36, and 15 mg for Days 43 and 50 administered into the SC tissue of the abdominal wall.
|
5 mg Tirzepatide (Cohort 3)
n=11 participants at risk
Participants received 5 mg tirzepatide administered into the SC tissue of the abdominal wall.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/9 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
6.2%
1/16 • Number of events 1 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/9 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
16.7%
2/12 • Number of events 2 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
25.0%
4/16 • Number of events 4 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • Number of events 4 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
8.3%
1/12 • Number of events 1 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/16 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
27.3%
3/11 • Number of events 9 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
66.7%
8/12 • Number of events 11 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
50.0%
8/16 • Number of events 9 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
25.0%
3/12 • Number of events 3 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
31.2%
5/16 • Number of events 7 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
25.0%
3/12 • Number of events 3 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/16 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
12.5%
2/16 • Number of events 2 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
9.1%
1/11 • Number of events 4 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
8.3%
1/12 • Number of events 3 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
12.5%
2/16 • Number of events 3 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
9.1%
1/11 • Number of events 8 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
|
General disorders
Asthenia
|
0.00%
0/9 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
6.2%
1/16 • Number of events 1 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
|
General disorders
Malaise
|
0.00%
0/9 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/16 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
9.1%
1/11 • Number of events 4 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
|
Infections and infestations
Bronchitis
|
0.00%
0/9 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
8.3%
1/12 • Number of events 1 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/16 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/9 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
6.2%
1/16 • Number of events 1 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/9 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
8.3%
1/12 • Number of events 1 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
6.2%
1/16 • Number of events 1 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
9.1%
1/11 • Number of events 1 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
|
Investigations
Amylase increased
|
0.00%
0/9 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
8.3%
1/12 • Number of events 1 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/16 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/9 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
6.2%
1/16 • Number of events 1 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
|
Investigations
Blood triglycerides increased
|
22.2%
2/9 • Number of events 3 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
6.2%
1/16 • Number of events 1 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
|
Investigations
Lipase increased
|
0.00%
0/9 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
8.3%
1/12 • Number of events 1 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
12.5%
2/16 • Number of events 4 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
|
Investigations
Weight decreased
|
0.00%
0/9 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
6.2%
1/16 • Number of events 1 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
|
Investigations
White blood cell count increased
|
0.00%
0/9 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
6.2%
1/16 • Number of events 1 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
9.1%
1/11 • Number of events 1 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/9 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
50.0%
6/12 • Number of events 6 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
62.5%
10/16 • Number of events 10 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
45.5%
5/11 • Number of events 6 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
6.2%
1/16 • Number of events 1 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
25.0%
3/12 • Number of events 3 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
6.2%
1/16 • Number of events 1 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 85 days
All randomized participants who received at least one dose of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60