Trial Outcomes & Findings for A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Mellitus (NCT NCT03131687)
NCT ID: NCT03131687
Last Updated: 2019-08-20
Results Overview
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.This was a Bayesian dose response analysis of HbA1c (%) change from baseline. At baseline: Mean (SD = Standard Deviation) of baseline HbA1c (%). After baseline: Posterior Mean (SD = Posterior Standard Deviation) of HbA1c (%) change from baseline. The Least Squares Mean is Posterior mean.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
318 participants
Primary outcome timeframe
Baseline, Week 26
Results posted on
2019-08-20
Participant Flow
Participant milestones
| Measure |
Placebo
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
|
1 mg Tirzepatide
1 milligrams (mg) tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
5 mg Tirzepatide
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
53
|
55
|
52
|
53
|
54
|
|
Overall Study
Received at Least One Dose of Study Drug
|
51
|
52
|
55
|
51
|
53
|
54
|
|
Overall Study
COMPLETED
|
45
|
44
|
52
|
48
|
45
|
49
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
3
|
4
|
8
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
|
1 mg Tirzepatide
1 milligrams (mg) tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
5 mg Tirzepatide
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
1
|
2
|
2
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
3
|
1
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
0
|
1
|
4
|
2
|
|
Overall Study
Participant Started New Diabetic Drug
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Principle Investigator Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Inadvertent Enrollment
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo
n=51 Participants
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
|
1 mg Tirzepatide
n=52 Participants
1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
5 mg Tirzepatide
n=55 Participants
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
n=51 Participants
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide
n=53 Participants
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
n=54 Participants
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
Total
n=316 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 8.85 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 8.85 • n=7 Participants
|
57.9 years
STANDARD_DEVIATION 8.22 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 9.92 • n=4 Participants
|
56.0 years
STANDARD_DEVIATION 7.58 • n=21 Participants
|
58.7 years
STANDARD_DEVIATION 7.81 • n=10 Participants
|
57.2 years
STANDARD_DEVIATION 8.54 • n=115 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
148 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
168 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
142 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
139 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
35 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=115 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
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
44 Participants
n=10 Participants
|
253 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Region of Enrollment
Puerto Rico
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
43 Participants
n=10 Participants
|
234 Participants
n=115 Participants
|
|
Region of Enrollment
Poland
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
31 Participants
n=115 Participants
|
|
Region of Enrollment
Slovakia
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
35 Participants
n=115 Participants
|
|
Hemoglobin A1C (HbA1c) at Baseline
|
8.04 Percentage of HbA1c
STANDARD_DEVIATION 0.861 • n=5 Participants
|
8.21 Percentage of HbA1c
STANDARD_DEVIATION 0.905 • n=7 Participants
|
8.17 Percentage of HbA1c
STANDARD_DEVIATION 0.961 • n=5 Participants
|
8.15 Percentage of HbA1c
STANDARD_DEVIATION 1.072 • n=4 Participants
|
8.13 Percentage of HbA1c
STANDARD_DEVIATION 1.061 • n=21 Participants
|
8.13 Percentage of HbA1c
STANDARD_DEVIATION 0.954 • n=10 Participants
|
8.14 Percentage of HbA1c
STANDARD_DEVIATION 0.966 • n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants who received at least one dose of study drug and had a baseline and postbaseline excluding data after rescue drug initiation.
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.This was a Bayesian dose response analysis of HbA1c (%) change from baseline. At baseline: Mean (SD = Standard Deviation) of baseline HbA1c (%). After baseline: Posterior Mean (SD = Posterior Standard Deviation) of HbA1c (%) change from baseline. The Least Squares Mean is Posterior mean.
Outcome measures
| Measure |
Placebo
n=44 Participants
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
|
1 mg Tirzepatide
n=45 Participants
1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
5 mg Tirzepatide
n=52 Participants
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
n=47 Participants
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide
n=44 Participants
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
n=49 Participants
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
|---|---|---|---|---|---|---|
|
Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c) Bayesian Dose Response
|
-0.06 Percentage of HbA1c
Standard Deviation 0.14
|
-1.06 Percentage of HbA1c
Standard Deviation 0.11
|
-1.73 Percentage of HbA1c
Standard Deviation 0.08
|
-1.89 Percentage of HbA1c
Standard Deviation 0.08
|
-1.94 Percentage of HbA1c
Standard Deviation 0.09
|
-1.21 Percentage of HbA1c
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least one dose of study drug and had a baseline and postbaseline value excluding data after rescue drug initiation.
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. This was a Bayesian dose response analysis of HbA1c (%) change from baseline. At baseline: Mean (SD = Standard Deviation) of baseline HbA1c (%). After baseline: Posterior Mean (SD = Posterior Standard Deviation) of HbA1c (%) change from baseline. The Least Squares Mean is Posterior mean.
Outcome measures
| Measure |
Placebo
n=48 Participants
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
|
1 mg Tirzepatide
n=45 Participants
1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
5 mg Tirzepatide
n=52 Participants
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
n=48 Participants
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide
n=48 Participants
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
n=51 Participants
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
|---|---|---|---|---|---|---|
|
Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) Bayesian Dose Response
|
-0.05 Percentage of HbA1c
Standard Deviation 0.13
|
-0.94 Percentage of HbA1c
Standard Deviation 0.10
|
-1.54 Percentage of HbA1c
Standard Deviation 0.07
|
-1.68 Percentage of HbA1c
Standard Deviation 0.08
|
-1.72 Percentage of HbA1c
Standard Deviation 0.08
|
-1.08 Percentage of HbA1c
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants who received at least one dose of study drug who had a baseline and postbaseline value excluding data after study drug discontinuation or rescue drug initiation.
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: Baseline + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment\*Time.
Outcome measures
| Measure |
Placebo
n=41 Participants
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
|
1 mg Tirzepatide
n=44 Participants
1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
5 mg Tirzepatide
n=47 Participants
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
n=43 Participants
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide
n=35 Participants
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
n=47 Participants
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
|---|---|---|---|---|---|---|
|
Change From Baseline to Week 26 in HbA1c
|
0.1 Percentage of HbA1c
Standard Error 0.16
|
-0.7 Percentage of HbA1c
Standard Error 0.16
|
-1.6 Percentage of HbA1c
Standard Error 0.15
|
-2.0 Percentage of HbA1c
Standard Error 0.16
|
-2.4 Percentage of HbA1c
Standard Error 0.17
|
-1.1 Percentage of HbA1c
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: randomized participants who received at least one dose of study drug who had a baseline and postbaseline value excluding data after study drug discontinuation or rescue drug initiation.
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: Baseline + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment\*Time.
Outcome measures
| Measure |
Placebo
n=44 Participants
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
|
1 mg Tirzepatide
n=44 Participants
1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
5 mg Tirzepatide
n=49 Participants
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
n=47 Participants
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide
n=36 Participants
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
n=49 Participants
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
|---|---|---|---|---|---|---|
|
Change From Baseline to Week 12 in HbA1c
|
-0.1 Percentage of HbA1c
Standard Error 0.13
|
-0.9 Percentage of HbA1c
Standard Error 0.13
|
-1.7 Percentage of HbA1c
Standard Error 0.13
|
-2.0 Percentage of HbA1c
Standard Error 0.13
|
-2.1 Percentage of HbA1c
Standard Error 0.15
|
-1.2 Percentage of HbA1c
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants who received at least one dose of study drug and had a baseline and postbaseline value excluding data after study drug discontinuation or rescue drug initiation.
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with independent variables: Baseline + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment\*Time.
Outcome measures
| Measure |
Placebo
n=41 Participants
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
|
1 mg Tirzepatide
n=44 Participants
1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
5 mg Tirzepatide
n=48 Participants
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
n=44 Participants
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide
n=35 Participants
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
n=47 Participants
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight
|
-0.4 Kilograms (Kg)
Standard Error 0.81
|
-0.9 Kilograms (Kg)
Standard Error 0.80
|
-4.8 Kilograms (Kg)
Standard Error 0.77
|
-8.7 Kilograms (Kg)
Standard Error 0.80
|
-11.3 Kilograms (Kg)
Standard Error 0.88
|
-2.7 Kilograms (Kg)
Standard Error 0.78
|
SECONDARY outcome
Timeframe: Week 26Population: All randomized participants who received at least one dose of study drug.
Percentage of participants with 5% or greater body weight loss from baseline last observation carried forward (LOCF) analyses using Logistic regression model with Baseline value + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin + Treatment as factors.
Outcome measures
| Measure |
Placebo
n=51 Participants
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
|
1 mg Tirzepatide
n=52 Participants
1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
5 mg Tirzepatide
n=55 Participants
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
n=51 Participants
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide
n=53 Participants
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
n=54 Participants
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With 5% or Greater Body Weight Loss From Baseline
|
0 percentage of participants
|
13.5 percentage of participants
|
47.3 percentage of participants
|
70.6 percentage of participants
|
62.3 percentage of participants
|
22.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: All randomized participants who received at least one dose of study drug.
Percentage of participants with 10% or greater body weight loss from baseline LOCF analyses using Logistic regression model with Baseline value + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin + Treatment as factors.
Outcome measures
| Measure |
Placebo
n=51 Participants
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
|
1 mg Tirzepatide
n=52 Participants
1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
5 mg Tirzepatide
n=55 Participants
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
n=51 Participants
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide
n=53 Participants
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
n=54 Participants
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With 10% or Greater Body Weight Loss From Baseline
|
0 percentage of participants
|
5.8 percentage of participants
|
16.4 percentage of participants
|
39.2 percentage of participants
|
37.7 percentage of participants
|
9.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: All randomized participants who received at least one dose of study drug excluding data after study drug discontinuation or rescue drug initiation.
Percentage of participants with HbA1c ≤6.5% at Week 26 using a logistic regression model for endpoint used last observation carried forward (LOCF) method including baseline value, baseline BMI Group, baseline Metformin and treatment as factors.
Outcome measures
| Measure |
Placebo
n=51 Participants
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
|
1 mg Tirzepatide
n=52 Participants
1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
5 mg Tirzepatide
n=55 Participants
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
n=50 Participants
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide
n=53 Participants
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
n=54 Participants
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reaching the HbA1c Target of ≤6.5%
|
2.0 percentage of participants
|
15.4 percentage of participants
|
63.6 percentage of participants
|
82.0 percentage of participants
|
58.5 percentage of participants
|
38.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: All randomized participants who received at least one dose of study drug excluding data after study drug discontinuation or rescue drug initiation.
Percentage of participants with HbA1c \<7.0% at Week 26 using a logistic regression model for endpoint used last observation carried forward (LOCF) method including baseline value, baseline BMI Group, baseline Metformin and treatment as factors.
Outcome measures
| Measure |
Placebo
n=51 Participants
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
|
1 mg Tirzepatide
n=52 Participants
1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
5 mg Tirzepatide
n=55 Participants
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
n=50 Participants
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide
n=53 Participants
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
n=54 Participants
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reaching the HbA1c Target of <7.0%
|
11.8 percentage of participants
|
32.7 percentage of participants
|
69.1 percentage of participants
|
90.0 percentage of participants
|
77.4 percentage of participants
|
51.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants who received at least one dose of study drug who had a baseline and postbaseline value excluding data after study drug discontinuation or rescue drug initiation.
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment\*Time.
Outcome measures
| Measure |
Placebo
n=40 Participants
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
|
1 mg Tirzepatide
n=44 Participants
1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
5 mg Tirzepatide
n=48 Participants
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
n=44 Participants
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide
n=35 Participants
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
n=46 Participants
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose
|
15.5 milligrams per deciliter (mg/dL)
Standard Error 6.66
|
-6.8 milligrams per deciliter (mg/dL)
Standard Error 6.43
|
-40.7 milligrams per deciliter (mg/dL)
Standard Error 6.23
|
-60.7 milligrams per deciliter (mg/dL)
Standard Error 6.36
|
-57.5 milligrams per deciliter (mg/dL)
Standard Error 7.10
|
-21.2 milligrams per deciliter (mg/dL)
Standard Error 6.40
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants who received at least one dose of study drug and had a baseline and postbaseline value.
LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag,Treatment, time, treatment\*time.
Outcome measures
| Measure |
Placebo
n=45 Participants
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
|
1 mg Tirzepatide
n=46 Participants
1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
5 mg Tirzepatide
n=53 Participants
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
n=48 Participants
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide
n=46 Participants
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
n=51 Participants
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
|
0.0 Millimoles Per Litre (mmol/L)
Standard Error 0.03
|
-0.0 Millimoles Per Litre (mmol/L)
Standard Error 0.03
|
0.0 Millimoles Per Litre (mmol/L)
Standard Error 0.03
|
0.0 Millimoles Per Litre (mmol/L)
Standard Error 0.03
|
0.1 Millimoles Per Litre (mmol/L)
Standard Error 0.03
|
0.0 Millimoles Per Litre (mmol/L)
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants who received at least one dose of study drug and had a baseline and postbaseline value.
LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment\*Time.
Outcome measures
| Measure |
Placebo
n=45 Participants
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
|
1 mg Tirzepatide
n=46 Participants
1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
5 mg Tirzepatide
n=53 Participants
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
n=48 Participants
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide
n=46 Participants
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
n=51 Participants
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Total Cholesterol
|
0.3 Millimoles Per Litre (mmol/L)
Standard Error 0.13
|
0.2 Millimoles Per Litre (mmol/L)
Standard Error 0.13
|
-0.1 Millimoles Per Litre (mmol/L)
Standard Error 0.12
|
-0.3 Millimoles Per Litre (mmol/L)
Standard Error 0.12
|
-0.3 Millimoles Per Litre (mmol/L)
Standard Error 0.13
|
-0.2 Millimoles Per Litre (mmol/L)
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants who received at least one dose of study drug and had a baseline and postbaseline value.
LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment\*Time.
Outcome measures
| Measure |
Placebo
n=45 Participants
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
|
1 mg Tirzepatide
n=46 Participants
1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
5 mg Tirzepatide
n=53 Participants
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
n=48 Participants
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide
n=46 Participants
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
n=51 Participants
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Triglycerides
|
0.3 Millimoles Per Litre (mmol/L)
Standard Error 0.16
|
-0.0 Millimoles Per Litre (mmol/L)
Standard Error 0.16
|
-0.5 Millimoles Per Litre (mmol/L)
Standard Error 0.15
|
-0.7 Millimoles Per Litre (mmol/L)
Standard Error 0.15
|
-0.8 Millimoles Per Litre (mmol/L)
Standard Error 0.16
|
-0.3 Millimoles Per Litre (mmol/L)
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants who received at least one dose of study drug and had a baseline and postbaseline value.
LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment\*Time.
Outcome measures
| Measure |
Placebo
n=42 Participants
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
|
1 mg Tirzepatide
n=45 Participants
1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
5 mg Tirzepatide
n=52 Participants
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
n=48 Participants
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide
n=45 Participants
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
n=50 Participants
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
|
0.2 Millimoles Per Litre (mmol/L)
Standard Error 0.12
|
0.2 Millimoles Per Litre (mmol/L)
Standard Error 0.11
|
0.0 Millimoles Per Litre (mmol/L)
Standard Error 0.11
|
-0.0 Millimoles Per Litre (mmol/L)
Standard Error 0.11
|
-0.1 Millimoles Per Litre (mmol/L)
Standard Error 0.12
|
-0.1 Millimoles Per Litre (mmol/L)
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants who received at least one dose of study drug and had a baseline and postbaseline value.
LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment\*Time.
Outcome measures
| Measure |
Placebo
n=42 Participants
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
|
1 mg Tirzepatide
n=44 Participants
1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
5 mg Tirzepatide
n=47 Participants
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
n=44 Participants
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide
n=35 Participants
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
n=47 Participants
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Waist Circumference
|
-1.3 centimeters (cm)
Standard Error 0.91
|
-2.1 centimeters (cm)
Standard Error 0.89
|
-5.1 centimeters (cm)
Standard Error 0.86
|
-7.4 centimeters (cm)
Standard Error 0.88
|
-10.2 centimeters (cm)
Standard Error 1.00
|
-2.5 centimeters (cm)
Standard Error 0.87
|
SECONDARY outcome
Timeframe: Baseline through Week 30Population: All randomized participants who received at least one dose of study drug.
Number of Participants With Anti-Drug Antibodies.
Outcome measures
| Measure |
Placebo
n=51 Participants
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
|
1 mg Tirzepatide
n=52 Participants
1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
5 mg Tirzepatide
n=55 Participants
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
n=51 Participants
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide
n=53 Participants
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
n=54 Participants
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Anti-Drug Antibodies
|
0 Participants
|
16 Participants
|
19 Participants
|
24 Participants
|
26 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose: Week 1,8,12 and 26; Postdose: Week 1,2,4 and 12Population: All randomized participants who received at least one dose of Tirzepatide study drug excluding post rescue data.
Pharmacokinetics (PK): Model Predicted Concentration at Steady State (Css) of Tirzepatide
Outcome measures
| Measure |
Placebo
n=52 Participants
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
|
1 mg Tirzepatide
n=55 Participants
1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
5 mg Tirzepatide
n=51 Participants
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
n=53 Participants
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Model Predicted Concentration at Steady State (Css) of Tirzepatide
|
78.6 Nanograms Per Millilitre (ng/mL)
Geometric Coefficient of Variation 29
|
394 Nanograms Per Millilitre (ng/mL)
Geometric Coefficient of Variation 29
|
787 Nanograms Per Millilitre (ng/mL)
Geometric Coefficient of Variation 29
|
1180 Nanograms Per Millilitre (ng/mL)
Geometric Coefficient of Variation 29
|
—
|
—
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
1 mg Tirzepatide
Serious events: 2 serious events
Other events: 17 other events
Deaths: 1 deaths
5 mg Tirzepatide
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
10 mg Tirzepatide
Serious events: 3 serious events
Other events: 32 other events
Deaths: 0 deaths
15 mg Tirzepatide + Placebo
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
1.5 mg Dulaglutide
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=51 participants at risk
Tirzepatide placebo and dulaglutide placebo administered (SC) once weekly.
|
1 mg Tirzepatide
n=52 participants at risk
1 mg tirzepatide and placebo given SC once weekly.
|
5 mg Tirzepatide
n=55 participants at risk
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
n=51 participants at risk
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide + Placebo
n=53 participants at risk
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
n=54 participants at risk
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/55 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/53 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/54 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/55 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/53 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Torsade de pointes
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/55 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/53 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/55 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/53 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/55 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/53 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/55 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/51 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/53 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.8%
1/55 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/53 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/55 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/53 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/54 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/55 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/51 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/53 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/55 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/53 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
3.9%
2/51 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/55 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/53 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/55 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/53 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/55 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/53 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/55 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/53 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/54 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
2.0%
1/51 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/55 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/53 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage iv
|
2.0%
1/51 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/55 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/53 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cluster headache
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/55 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/53 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/54 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/55 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/53 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/55 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/53 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/55 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/51 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/53 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/55 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/53 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=51 participants at risk
Tirzepatide placebo and dulaglutide placebo administered (SC) once weekly.
|
1 mg Tirzepatide
n=52 participants at risk
1 mg tirzepatide and placebo given SC once weekly.
|
5 mg Tirzepatide
n=55 participants at risk
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
10 mg Tirzepatide
n=51 participants at risk
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
15 mg Tirzepatide + Placebo
n=53 participants at risk
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
|
1.5 mg Dulaglutide
n=54 participants at risk
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.9%
2/51 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.8%
1/55 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/51 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
7.5%
4/53 • Number of events 7 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.0%
1/51 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.6%
2/55 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
9.8%
5/51 • Number of events 5 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
7.5%
4/53 • Number of events 4 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
5.6%
3/54 • Number of events 3 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
1/51 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.8%
1/55 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
5.7%
3/53 • Number of events 3 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/54 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.6%
2/55 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
11.8%
6/51 • Number of events 6 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.8%
2/53 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
5.6%
3/54 • Number of events 3 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.9%
2/51 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
13.5%
7/52 • Number of events 13 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
23.6%
13/55 • Number of events 17 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
23.5%
12/51 • Number of events 13 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
32.1%
17/53 • Number of events 23 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
16.7%
9/54 • Number of events 12 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.8%
1/55 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
11.8%
6/51 • Number of events 7 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.8%
2/53 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.7%
2/54 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
3/51 • Number of events 3 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
20.0%
11/55 • Number of events 17 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
21.6%
11/51 • Number of events 13 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
39.6%
21/53 • Number of events 29 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
29.6%
16/54 • Number of events 22 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/51 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
7.3%
4/55 • Number of events 8 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
15.7%
8/51 • Number of events 9 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
26.4%
14/53 • Number of events 20 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
9.3%
5/54 • Number of events 6 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
5.9%
3/51 • Number of events 4 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.8%
1/55 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
5.9%
3/51 • Number of events 3 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/53 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.7%
2/54 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
2.0%
1/51 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.6%
2/55 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
7.8%
4/51 • Number of events 4 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/53 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.7%
2/54 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
2/51 • Number of events 3 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
5.5%
3/55 • Number of events 3 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.9%
2/51 • Number of events 5 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
5.7%
3/53 • Number of events 6 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
11.1%
6/54 • Number of events 6 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
3/51 • Number of events 3 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
5.5%
3/55 • Number of events 3 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.9%
2/51 • Number of events 3 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/53 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
7.4%
4/54 • Number of events 5 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.6%
2/55 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/51 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
7.5%
4/53 • Number of events 4 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.9%
2/51 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
5.5%
3/55 • Number of events 3 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/53 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/54 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Amylase increased
|
2.0%
1/51 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.6%
2/55 • Number of events 3 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
7.8%
4/51 • Number of events 7 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/53 • Number of events 3 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Lipase increased
|
2.0%
1/51 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
5.5%
3/55 • Number of events 3 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
7.8%
4/51 • Number of events 7 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.8%
2/53 • Number of events 3 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/54 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.6%
2/55 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
9.8%
5/51 • Number of events 5 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.8%
2/53 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.0%
1/51 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
20.0%
11/55 • Number of events 12 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
25.5%
13/51 • Number of events 14 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
18.9%
10/53 • Number of events 13 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
5.6%
3/54 • Number of events 3 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
3.9%
2/51 • Number of events 3 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 4 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.6%
2/55 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.9%
2/51 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
9.4%
5/53 • Number of events 5 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/54 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
3.9%
2/51 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
3.6%
2/55 • Number of events 2 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/51 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
9.4%
5/53 • Number of events 5 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/54 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/51 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.8%
1/55 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
5.7%
3/53 • Number of events 3 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/54 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
2.0%
1/51 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/55 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/51 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
1.9%
1/53 • Number of events 1 • Up To 34 Weeks
All randomized participants who received at least one dose of study drug.
|
5.6%
3/54 • Number of events 3 • Up To 34 Weeks
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