Trial Outcomes & Findings for A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus (T2DM) (NCT NCT03951753)
NCT ID: NCT03951753
Last Updated: 2023-03-20
Results Overview
cDI is defined as the product of the M-value derived from the hyperinsulinemic euglycemic clamp over the last 30 minutes and total insulin secretion (ISR AUC0-120min) derived from the insulin secretion rate based on C-peptide using the using the deconvolution technique divided by the total glucose AUC0-120min from the hyperglycemic clamp portion of the study. Least squares (LS) mean was determined by analysis of covariance (ANCOVA) model for endpoint measures: log(Actual Measurement/Baseline) = log(Baseline) + Treatment (Type III sum of squares).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
117 participants
Primary outcome timeframe
Baseline, Week 28
Results posted on
2023-03-20
Participant Flow
Participant milestones
| Measure |
Tirzepatide 15 mg
Participants received 15 milligram (mg) Tirzepatide administered subcutaneously (SC) once weekly for 28 weeks.
|
Semaglutide 1 mg
Participants received 1 mg Semaglutide administered SC once weekly for 28 weeks.
|
Placebo
Participants received Placebo administered SC once weekly for 28 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
45
|
44
|
28
|
|
Overall Study
COMPLETED
|
41
|
43
|
24
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
4
|
Reasons for withdrawal
| Measure |
Tirzepatide 15 mg
Participants received 15 milligram (mg) Tirzepatide administered subcutaneously (SC) once weekly for 28 weeks.
|
Semaglutide 1 mg
Participants received 1 mg Semaglutide administered SC once weekly for 28 weeks.
|
Placebo
Participants received Placebo administered SC once weekly for 28 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus (T2DM)
Baseline characteristics by cohort
| Measure |
Tirzepatide 15 mg
n=45 Participants
Participants received 15 mg Tirzepatide administered SC once weekly for 28 weeks.
|
Semaglutide 1 mg
n=44 Participants
Participants received 1 mg Semaglutide administered SC once weekly for 28 weeks.
|
Placebo
n=28 Participants
Participants received Placebo administered SC once weekly for 28 weeks.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
63.7 years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
60.4 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
61.9 years
STANDARD_DEVIATION 6.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
45 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
|
HbA1c (%)
|
7.83 percentage
STANDARD_DEVIATION 0.72 • n=5 Participants
|
7.70 percentage
STANDARD_DEVIATION 0.60 • n=7 Participants
|
7.90 percentage
STANDARD_DEVIATION 0.51 • n=5 Participants
|
7.80 percentage
STANDARD_DEVIATION 0.63 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 28Population: All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
cDI is defined as the product of the M-value derived from the hyperinsulinemic euglycemic clamp over the last 30 minutes and total insulin secretion (ISR AUC0-120min) derived from the insulin secretion rate based on C-peptide using the using the deconvolution technique divided by the total glucose AUC0-120min from the hyperglycemic clamp portion of the study. Least squares (LS) mean was determined by analysis of covariance (ANCOVA) model for endpoint measures: log(Actual Measurement/Baseline) = log(Baseline) + Treatment (Type III sum of squares).
Outcome measures
| Measure |
Tirzepatide 15 mg
n=39 Participants
Participants received 15 mg Tirzepatide administered SC once weekly for 28 weeks.
|
Semaglutide 1 mg
n=39 Participants
Participants received 1 mg Semaglutide administered SC once weekly for 28 weeks.
|
Placebo
n=24 Participants
Participants received Placebo administered SC once weekly for 28 weeks.
|
|---|---|---|---|
|
Change From Baseline in Total Clamp Disposition Index (cDI)
|
1.9 pmol*m-2*L*min-2*kg-1
Standard Error 0.16
|
1.1 pmol*m-2*L*min-2*kg-1
Standard Error 0.10
|
0.0 pmol*m-2*L*min-2*kg-1
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
Fasting glucose is a test to determine sugar levels in blood sample after an overnight fast. Fasting glucose was measured prior to standardized mixed-meal tolerance tests (sMMTT). LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Treatment (Type III sum of squares).
Outcome measures
| Measure |
Tirzepatide 15 mg
n=41 Participants
Participants received 15 mg Tirzepatide administered SC once weekly for 28 weeks.
|
Semaglutide 1 mg
n=43 Participants
Participants received 1 mg Semaglutide administered SC once weekly for 28 weeks.
|
Placebo
n=24 Participants
Participants received Placebo administered SC once weekly for 28 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Glucose
|
-51.4 milligrams per decilitre (mg/dL)
Standard Error 2.30
|
-42.4 milligrams per decilitre (mg/dL)
Standard Error 2.22
|
-4.3 milligrams per decilitre (mg/dL)
Standard Error 2.98
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
Total AUC from time zero to 240 minutes after start of the meal \[AUC0-240min\]) during sMMTT was evaluated. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Treatment (Type III sum of squares) and ANOVA model for baseline measures: Variable = Treatment (Type III sum of squares).
Outcome measures
| Measure |
Tirzepatide 15 mg
n=41 Participants
Participants received 15 mg Tirzepatide administered SC once weekly for 28 weeks.
|
Semaglutide 1 mg
n=43 Participants
Participants received 1 mg Semaglutide administered SC once weekly for 28 weeks.
|
Placebo
n=24 Participants
Participants received Placebo administered SC once weekly for 28 weeks.
|
|---|---|---|---|
|
Change From Baseline in Postmeal Glucose
|
-17414.0 Milligrams per decilitre*minute
Standard Error 726.02
|
14236.9 Milligrams per decilitre*minute
Standard Error 709.53
|
459.2 Milligrams per decilitre*minute
Standard Error 947.50
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by mixed model repeated measures; (MMRM) model for post-baseline measures: Variable = Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
Tirzepatide 15 mg
n=41 Participants
Participants received 15 mg Tirzepatide administered SC once weekly for 28 weeks.
|
Semaglutide 1 mg
n=43 Participants
Participants received 1 mg Semaglutide administered SC once weekly for 28 weeks.
|
Placebo
n=24 Participants
Participants received Placebo administered SC once weekly for 28 weeks.
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c)
|
2.05 % of HbA1c
Standard Error 0.079
|
-1.64 % of HbA1c
Standard Error 0.078
|
0.29 % of HbA1c
Standard Error 0.101
|
SECONDARY outcome
Timeframe: Baseline and Week 28Population: All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
Total Insulin Secretion Rate During the 120-Minute Hyperglycemic Clamp (ISR0-120min) will be determined from C-peptide concentrations using the deconvolution technique. LS mean was determined by ANCOVA model for endpoint measures: log(Actual Measurement/Baseline) = log(Baseline) + Treatment (Type III sum of squares).
Outcome measures
| Measure |
Tirzepatide 15 mg
n=41 Participants
Participants received 15 mg Tirzepatide administered SC once weekly for 28 weeks.
|
Semaglutide 1 mg
n=43 Participants
Participants received 1 mg Semaglutide administered SC once weekly for 28 weeks.
|
Placebo
n=24 Participants
Participants received Placebo administered SC once weekly for 28 weeks.
|
|---|---|---|---|
|
Change From Baseline in Total Insulin Secretion Rate During the 120-Minute Hyperglycemic Clamp (ISR0-120min)
|
388.6 pmol/min/m^2
Standard Error 20.17
|
286.6 pmol/min/m^2
Standard Error 15.82
|
7.4 pmol/min/m^2
Standard Error 7.15
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
Hyperinsulinemic euglycemic clamp M-value is calculated from glucose infusion rate (GIR) over the last 30 minutes, corresponding to steady-state (+150 to +180 minutes), corrected for urine loss and space. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Treatment (Type III sum of squares).
Outcome measures
| Measure |
Tirzepatide 15 mg
n=41 Participants
Participants received 15 mg Tirzepatide administered SC once weekly for 28 weeks.
|
Semaglutide 1 mg
n=39 Participants
Participants received 1 mg Semaglutide administered SC once weekly for 28 weeks.
|
Placebo
n=24 Participants
Participants received Placebo administered SC once weekly for 28 weeks.
|
|---|---|---|---|
|
Change From Baseline in Hyperinsulinemic Euglycemic Clamp M-value
|
19.2 umol/min/kg [body weight]
Standard Error 1.93
|
10.7 umol/min/kg [body weight]
Standard Error 1.99
|
-0.6 umol/min/kg [body weight]
Standard Error 2.53
|
SECONDARY outcome
Timeframe: Baseline and Week 28Population: All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
Glucagon concentration was measured prior to sMMTT. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Treatment (Type III sum of squares).
Outcome measures
| Measure |
Tirzepatide 15 mg
n=40 Participants
Participants received 15 mg Tirzepatide administered SC once weekly for 28 weeks.
|
Semaglutide 1 mg
n=40 Participants
Participants received 1 mg Semaglutide administered SC once weekly for 28 weeks.
|
Placebo
n=22 Participants
Participants received Placebo administered SC once weekly for 28 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glucagon Concentration at Fasting
|
-3.6 picomoles per litre (pmol/L)
Standard Error 0.55
|
-2.8 picomoles per litre (pmol/L)
Standard Error 0.55
|
0.8 picomoles per litre (pmol/L)
Standard Error 0.75
|
SECONDARY outcome
Timeframe: Baseline and Week 28Population: All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
Total AUC from time zero to 240 minutes after start of the meal \[AUC0-240min\]) during sMMTT. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Treatment (Type III sum of squares).
Outcome measures
| Measure |
Tirzepatide 15 mg
n=40 Participants
Participants received 15 mg Tirzepatide administered SC once weekly for 28 weeks.
|
Semaglutide 1 mg
n=39 Participants
Participants received 1 mg Semaglutide administered SC once weekly for 28 weeks.
|
Placebo
n=22 Participants
Participants received Placebo administered SC once weekly for 28 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glucagon Concentration at Postmeal
|
-843.6 (pmol/L)*min
Standard Error 86.26
|
-502.0 (pmol/L)*min
Standard Error 87.33
|
-205.9 (pmol/L)*min
Standard Error 116.31
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
Ad libitum meal served buffet-style. Food intake was recorded during a 45 minute period. The sum of the caloric breakdown (carbohydrates, protein, and fats) was calculated from the respective nutritional information of the food items. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
Tirzepatide 15 mg
n=41 Participants
Participants received 15 mg Tirzepatide administered SC once weekly for 28 weeks.
|
Semaglutide 1 mg
n=43 Participants
Participants received 1 mg Semaglutide administered SC once weekly for 28 weeks.
|
Placebo
n=24 Participants
Participants received Placebo administered SC once weekly for 28 weeks.
|
|---|---|---|---|
|
Change From Baseline in Food Intake During Ad Libitum Meal
|
-348.4 kilocalorie (kcal)
Standard Error 34.59
|
-284.1 kilocalorie (kcal)
Standard Error 33.94
|
-38.6 kilocalorie (kcal)
Standard Error 45.17
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Semaglutide 1 mg
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Tirzepatide 15 mg
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=28 participants at risk
Participants received Placebo administered SC once weekly for 28 weeks.
|
Semaglutide 1 mg
n=44 participants at risk
Participants received 1 mg Semaglutide administered SC once weekly for 28 weeks.
|
Tirzepatide 15 mg
n=45 participants at risk
Participants received 15 mg Tirzepatide administered SC once weekly for 28 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
3.6%
1/28 • Number of events 1 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
0.00%
0/44 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
0.00%
0/45 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
Gastrointestinal disorders
Subacute pancreatitis
|
3.6%
1/28 • Number of events 1 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
0.00%
0/44 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
0.00%
0/45 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/28 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
0.00%
0/44 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
2.2%
1/45 • Number of events 1 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
Other adverse events
| Measure |
Placebo
n=28 participants at risk
Participants received Placebo administered SC once weekly for 28 weeks.
|
Semaglutide 1 mg
n=44 participants at risk
Participants received 1 mg Semaglutide administered SC once weekly for 28 weeks.
|
Tirzepatide 15 mg
n=45 participants at risk
Participants received 15 mg Tirzepatide administered SC once weekly for 28 weeks.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
3.6%
1/28 • Number of events 1 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
2.3%
1/44 • Number of events 1 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
8.9%
4/45 • Number of events 4 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.6%
1/28 • Number of events 1 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
11.4%
5/44 • Number of events 5 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
11.1%
5/45 • Number of events 5 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/28 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
4.5%
2/44 • Number of events 3 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
11.1%
5/45 • Number of events 5 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.7%
3/28 • Number of events 3 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
9.1%
4/44 • Number of events 6 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
11.1%
5/45 • Number of events 5 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/28 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
18.2%
8/44 • Number of events 10 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
13.3%
6/45 • Number of events 6 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.4%
6/28 • Number of events 8 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
29.5%
13/44 • Number of events 17 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
20.0%
9/45 • Number of events 10 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
2/28 • Number of events 3 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
31.8%
14/44 • Number of events 23 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
6.7%
3/45 • Number of events 3 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/28 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
18.2%
8/44 • Number of events 8 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
17.8%
8/45 • Number of events 9 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
7/28 • Number of events 8 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
29.5%
13/44 • Number of events 22 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
24.4%
11/45 • Number of events 22 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28 • Number of events 1 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
11.4%
5/44 • Number of events 10 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
6.7%
3/45 • Number of events 3 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
General disorders
Asthenia
|
0.00%
0/28 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
6.8%
3/44 • Number of events 3 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
6.7%
3/45 • Number of events 3 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
General disorders
Early satiety
|
21.4%
6/28 • Number of events 6 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
27.3%
12/44 • Number of events 12 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
35.6%
16/45 • Number of events 16 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
General disorders
Fatigue
|
7.1%
2/28 • Number of events 2 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
22.7%
10/44 • Number of events 11 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
11.1%
5/45 • Number of events 6 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
General disorders
Injection site haematoma
|
42.9%
12/28 • Number of events 20 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
27.3%
12/44 • Number of events 21 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
26.7%
12/45 • Number of events 21 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
General disorders
Injection site pain
|
7.1%
2/28 • Number of events 4 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
6.8%
3/44 • Number of events 3 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
2.2%
1/45 • Number of events 1 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
Infections and infestations
Nasopharyngitis
|
10.7%
3/28 • Number of events 3 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
18.2%
8/44 • Number of events 14 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
15.6%
7/45 • Number of events 8 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
Investigations
Lipase increased
|
7.1%
2/28 • Number of events 2 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
4.5%
2/44 • Number of events 2 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
11.1%
5/45 • Number of events 7 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/28 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
0.00%
0/44 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
6.7%
3/45 • Number of events 3 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
7/28 • Number of events 7 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
70.5%
31/44 • Number of events 34 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
60.0%
27/45 • Number of events 29 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
2/28 • Number of events 2 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
4.5%
2/44 • Number of events 2 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
6.7%
3/45 • Number of events 3 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/28 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
4.5%
2/44 • Number of events 2 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
6.7%
3/45 • Number of events 4 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
|
Nervous system disorders
Headache
|
17.9%
5/28 • Number of events 5 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
15.9%
7/44 • Number of events 11 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
8.9%
4/45 • Number of events 5 • Up to Week 32
All randomly assigned participants who received at least 1 dose of study drug and have evaluable data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place