Trial Outcomes & Findings for A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN) (NCT NCT05024032)
NCT ID: NCT05024032
Last Updated: 2024-01-19
Results Overview
Mean Percent Change from Baseline in Body Weight. Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with Baseline + Sex + Presence of Comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
210 participants
Primary outcome timeframe
Baseline, Week 52
Results posted on
2024-01-19
Participant Flow
Participant milestones
| Measure |
10 Milligrams (mg) Tirzepatide
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered subcutaneously (SC) once weekly (QW).
|
15 mg Tirzepatide
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Overall Study
STARTED
|
70
|
71
|
69
|
|
Overall Study
Received At Least One Dose
|
70
|
71
|
69
|
|
Overall Study
COMPLETED
|
69
|
67
|
65
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
4
|
Reasons for withdrawal
| Measure |
10 Milligrams (mg) Tirzepatide
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered subcutaneously (SC) once weekly (QW).
|
15 mg Tirzepatide
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
4
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Protocol Deviation
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)
Baseline characteristics by cohort
| Measure |
10 mg Tirzepatide
n=70 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=71 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=69 Participants
Participants received matching placebo SC QW.
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.70 years
STANDARD_DEVIATION 7.24 • n=99 Participants
|
35.80 years
STANDARD_DEVIATION 9.33 • n=107 Participants
|
37.80 years
STANDARD_DEVIATION 10.24 • n=206 Participants
|
36.10 years
STANDARD_DEVIATION 9.07 • n=7 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
103 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
107 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
70 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
210 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
China
|
70 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
210 Participants
n=7 Participants
|
|
Body Weight
|
92.2 kilograms (kg)
STANDARD_DEVIATION 16.2 • n=99 Participants
|
91.3 kilograms (kg)
STANDARD_DEVIATION 16.2 • n=107 Participants
|
92.0 kilograms (kg)
STANDARD_DEVIATION 15.8 • n=206 Participants
|
91.8 kilograms (kg)
STANDARD_DEVIATION 16.0 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: All participants who received at least one dose of study drug and had evaluable body weight data.
Mean Percent Change from Baseline in Body Weight. Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with Baseline + Sex + Presence of Comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=70 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=68 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=68 Participants
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Mean Percent Change From Baseline in Body Weight
|
-14.4 Percent change
Standard Error 0.98
|
-19.9 Percent change
Standard Error 1.01
|
-2.4 Percent change
Standard Error 1.00
|
PRIMARY outcome
Timeframe: Week 52Population: All participants who received at least one dose of study drug and had evaluable body weight data.
Percentage of Participants who Achieve ≥5% Body Weight Reduction. A logistic regression model was used for this analysis.
Outcome measures
| Measure |
10 mg Tirzepatide
n=70 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=68 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=68 Participants
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
|
91.43 Percentage of participants
|
92.65 Percentage of participants
|
29.41 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 20Population: All participants who received at least one dose of study drug and had evaluable body weight data.
Mean Change from Baseline in Body Weight. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=70 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=68 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=68 Participants
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Mean Change From Baseline in Body Weight
|
-9.0 kilograms (kg)
Standard Error 0.59
|
-11.1 kilograms (kg)
Standard Error 0.61
|
-1.8 kilograms (kg)
Standard Error 0.60
|
SECONDARY outcome
Timeframe: Week 52Population: All participants who received at least one dose of study drug and had evaluable body weight data.
Percentage of Participants who Achieve ≥10% Body Weight Reduction. A logistic regression model was used for this analysis.
Outcome measures
| Measure |
10 mg Tirzepatide
n=70 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=68 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=68 Participants
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
|
70.0 Percentage of participants
|
83.82 Percentage of participants
|
14.71 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: All participants who received at least one dose of study drug and evaluable body weight data.
Percentage of Participants who Achieve ≥15% Body Weight Reduction. A logistic regression model was used for this analysis.
Outcome measures
| Measure |
10 mg Tirzepatide
n=70 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=68 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=68 Participants
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
|
48.57 Percentage of participants
|
72.06 Percentage of participants
|
2.94 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All participants who received at least one dose of study drug and had evaluable waist circumference data.
Mean Change from Baseline in Waist Circumference. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=70 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=68 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=68 Participants
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Mean Change From Baseline in Waist Circumference
|
-11.9 centimeters (cm)
Standard Error 0.83
|
-16.4 centimeters (cm)
Standard Error 0.85
|
-2.7 centimeters (cm)
Standard Error 0.84
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All participants who received at least one dose of study drug and had evaluable body weight data.
Mean Change from Baseline in Absolute Body Weight. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=70 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=68 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=68 Participants
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Mean Change From Baseline in Absolute Body Weight
|
-13.1 kilograms (kg)
Standard Error 0.93
|
-18.1 kilograms (kg)
Standard Error 0.95
|
-2.1 kilograms (kg)
Standard Error 0.94
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All participants who received at least one dose of study drug and had evaluable BMI data.
Mean Change from Baseline in BMI. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=70 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=68 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=68 Participants
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Mean Change From Baseline in Body Mass Index (BMI)
|
-4.7 kilograms per metres squared (kg/m^2)
Standard Error 0.29
|
-6.4 kilograms per metres squared (kg/m^2)
Standard Error 0.30
|
-0.8 kilograms per metres squared (kg/m^2)
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: all participants who received at least one dose of study drug and had evaluable HbA1c data.
Mean Change from Baseline in HbA1c. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=69 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=66 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=67 Participants
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Mean Change From Baseline in Hemoglobin A1c (HbA1c)
|
-0.34 Percentage of HbA1c
Standard Error 0.032
|
-0.35 Percentage of HbA1c
Standard Error 0.033
|
0.03 Percentage of HbA1c
Standard Error 0.033
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All participants who received at least one dose of study drug and had evaluable fasting glucose data.
Mean Change from Baseline in FSG. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=69 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=66 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=67 Participants
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Mean Change From Baseline in Fasting Glucose (FSG)
|
-0.25 millimoles per liter (mmol/L)
Standard Error 0.050
|
-0.33 millimoles per liter (mmol/L)
Standard Error 0.052
|
0.22 millimoles per liter (mmol/L)
Standard Error 0.051
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All participants who received at least one dose of study drug and had evaluable SF-36v2 data.
The SF-36v2 acute form, 1-week recall assesses participants' health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Information from these 8 domains is further aggregated into 2 health component summary scores: Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths. Scoring of each domain and both summary scores are norm based and presented in the form of T scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores. LS mean was determined using analysis of covariance (ANCOVA) model using Baseline + Sex + Presence of comorbidities + Treatment (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=62 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=58 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=58 Participants
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Mean Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
|
2.0 Score on a scale
Standard Error 0.40
|
1.9 Score on a scale
Standard Error 0.42
|
0.8 Score on a scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All participants who received at least one dose of study drug and had evaluable IWQOL-Lite-CT data.
The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related HRQoL: Physical (7 items) and Psychosocial (13 items). A 5-item subset of the Physical domain - the Physical Function composite - is also supported. Items in the Physical Function composite describe physical impacts related to general and specific physical activities. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. LS mean was determined using ANCOVA model with Baseline + Sex + Presence of comorbidities + Treatment (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=62 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=58 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=58 Participants
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Mean Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
|
11.2 Score on a scale
Standard Error 1.44
|
12.0 Score on a scale
Standard Error 1.48
|
3.5 Score on a scale
Standard Error 1.48
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All participants who received at least one dose of study drug and had evaluable blood pressure data.
LS mean was determined using MMRM model with Variable = Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=119 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=58 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Mean Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg)
|
-6.1 millimeters of Mercury (mmHg)
Standard Error 0.62
|
-1.3 millimeters of Mercury (mmHg)
Standard Error 0.88
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All participants who received at least one dose of study drug and had evaluable blood pressure data.
LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=119 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=58 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Mean Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg)
|
-9.6 millimeters of Mercury (mmHg)
Standard Error 0.87
|
-3.5 millimeters of Mercury (mmHg)
Standard Error 1.24
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
LS mean was determined using MMRM model using log (Actual measurement/Baseline) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=123 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=61 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Mean Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
|
-0.37 millimoles per liter (mmol/L)
Standard Error 0.055
|
-0.06 millimoles per liter (mmol/L)
Standard Error 0.085
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=123 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=61 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Mean Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
|
0.12 millimoles per liter (mmol/L)
Standard Error 0.017
|
0.03 millimoles per liter (mmol/L)
Standard Error 0.023
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=123 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=61 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Mean Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
|
-0.17 millimoles per liter (mmol/L)
Standard Error 0.056
|
-0.11 millimoles per liter (mmol/L)
Standard Error 0.081
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=123 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=61 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Mean Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
|
-0.28 millimoles per liter (mmol/L)
Standard Error 0.019
|
-0.03 millimoles per liter (mmol/L)
Standard Error 0.042
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=123 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=61 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Mean Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg)
|
-0.63 millimoles per liter (mmol/L)
Standard Error 0.045
|
-0.05 millimoles per liter (mmol/L)
Standard Error 0.099
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=123 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=61 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Mean Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 10 mg and 15 mg)
|
-0.16 millimoles per liter (mmol/L)
Standard Error 0.013
|
-0.10 millimoles per liter (mmol/L)
Standard Error 0.023
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All participants who received at least one dose of study drug and had evaluable fasting insulin data.
LS mean was determined using MMRM model with log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=135 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=66 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Mean Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 10 mg and 15 mg)
|
-6.5 milliunits per liter (mU/L)
Standard Error 0.42
|
-0.2 milliunits per liter (mU/L)
Standard Error 1.09
|
—
|
Adverse Events
10 mg Tirzepatide
Serious events: 3 serious events
Other events: 61 other events
Deaths: 0 deaths
15 mg Tirzepatide
Serious events: 8 serious events
Other events: 56 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
10 mg Tirzepatide
n=70 participants at risk
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=71 participants at risk
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=69 participants at risk
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
1.4%
1/70 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/71 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/69 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/70 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
1.4%
1/71 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/69 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/70 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/71 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
1.4%
1/69 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/70 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
1.4%
1/71 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/69 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Infections and infestations
Covid-19
|
0.00%
0/70 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/71 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
1.4%
1/69 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/35 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/36 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
2.8%
1/36 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/70 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/71 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
1.4%
1/69 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/70 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
1.4%
1/71 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/69 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.4%
1/70 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/71 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/69 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/70 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
1.4%
1/71 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/69 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/70 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
1.4%
1/71 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/69 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/70 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/71 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
1.4%
1/69 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.00%
0/70 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
1.4%
1/71 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/69 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/70 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
1.4%
1/71 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/69 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/70 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/71 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
1.4%
1/69 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/70 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
1.4%
1/71 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/69 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Reproductive system and breast disorders
Uterine polyp
|
2.9%
1/35 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/35 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/33 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.00%
0/70 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
1.4%
1/71 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/69 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/35 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/35 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
3.0%
1/33 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Surgical and medical procedures
Medical device removal
|
0.00%
0/70 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/71 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
1.4%
1/69 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
Other adverse events
| Measure |
10 mg Tirzepatide
n=70 participants at risk
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=71 participants at risk
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=69 participants at risk
Participants received matching placebo SC QW.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
18.6%
13/70 • Number of events 62 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
12.7%
9/71 • Number of events 40 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
1.4%
1/69 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
4/70 • Number of events 4 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
7.0%
5/71 • Number of events 5 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
2.9%
2/69 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
5/70 • Number of events 10 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
2.8%
2/71 • Number of events 5 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/69 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
28/70 • Number of events 121 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
40.8%
29/71 • Number of events 109 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
8.7%
6/69 • Number of events 11 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Flatulence
|
8.6%
6/70 • Number of events 13 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
8.5%
6/71 • Number of events 13 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/69 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Nausea
|
30.0%
21/70 • Number of events 57 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
32.4%
23/71 • Number of events 79 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
5.8%
4/69 • Number of events 11 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Vomiting
|
11.4%
8/70 • Number of events 23 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
19.7%
14/71 • Number of events 53 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
4.3%
3/69 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
General disorders
Injection site reaction
|
5.7%
4/70 • Number of events 11 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
2.8%
2/71 • Number of events 6 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/69 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
4.3%
3/70 • Number of events 4 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
1.4%
1/71 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
8.7%
6/69 • Number of events 7 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Infections and infestations
Gastroenteritis
|
11.4%
8/70 • Number of events 9 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
2.8%
2/71 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/69 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Infections and infestations
Gingivitis
|
7.1%
5/70 • Number of events 5 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
1.4%
1/71 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/69 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Infections and infestations
Upper respiratory tract infection
|
22.9%
16/70 • Number of events 25 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
23.9%
17/71 • Number of events 20 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
17.4%
12/69 • Number of events 13 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Infections and infestations
Vaginal infection
|
2.9%
1/35 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
5.7%
2/35 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
9.1%
3/33 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Investigations
Amylase increased
|
7.1%
5/70 • Number of events 5 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
1.4%
1/71 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/69 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Investigations
Lipase increased
|
7.1%
5/70 • Number of events 6 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
7.0%
5/71 • Number of events 5 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/69 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
27.1%
19/70 • Number of events 75 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
28.2%
20/71 • Number of events 72 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
11.6%
8/69 • Number of events 8 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
4.3%
3/70 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
7.0%
5/71 • Number of events 5 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
11.6%
8/69 • Number of events 8 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Nervous system disorders
Dizziness
|
2.9%
2/70 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
5.6%
4/71 • Number of events 37 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
4.3%
3/69 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
5.7%
2/35 • Number of events 2 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/35 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
3.0%
1/33 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.4%
1/70 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
5.6%
4/71 • Number of events 6 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/69 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
|
Surgical and medical procedures
Abortion induced
|
8.6%
3/35 • Number of events 3 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
2.9%
1/35 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
3.0%
1/33 • Number of events 1 • Baseline Through Safety Follow-Up (Up To Week 56)
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60