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A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight (SURMOUNT-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04184622
Recruitment Status : Active, not recruiting
First Posted : December 3, 2019
Results First Posted : April 24, 2023
Last Update Posted : April 18, 2024
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Overweight
Obesity
Interventions Drug: Tirzepatide
Drug: Placebo
Enrollment 2539
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo 5 Milligrams (mg) Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide
Hide Arm/Group Description Placebo administered subcutaneously (SC) once a week. 5 mg tirzepatide administered SC once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week.
Period Title: Overall Study
Started 643 630 636 630
Completed 495 561 562 566
Not Completed 148 69 74 64
Reason Not Completed
Adverse Event             7             7             11             8
Death             4             4             2             1
Lost to Follow-up             41             19             20             15
Missing Weight at Week 72             1             0             1             0
Other - as reported by the investigator             22             7             5             12
Physician Decision             0             0             3             1
Pregnancy             4             4             3             5
Protocol Deviation             1             0             0             0
Withdrawal by Subject             68             28             29             22
Arm/Group Title Placebo 5 Milligrams (mg) Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Total
Hide Arm/Group Description Placebo administered SC once a week. 5 mg tirzepatide administered SC once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week. Total of all reporting groups
Overall Number of Baseline Participants 643 630 636 630 2539
Hide Baseline Analysis Population Description
All participants who are randomly assigned a study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 643 participants 630 participants 636 participants 630 participants 2539 participants
44.4  (12.5) 45.6  (12.7) 44.7  (12.4) 44.9  (12.3) 44.9  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 643 participants 630 participants 636 participants 630 participants 2539 participants
Female 436 426 427 425 1714
Male 207 204 209 205 825
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 643 participants 630 participants 636 participants 630 participants 2539 participants
American Indian or Alaska Native 58 56 58 59 231
Asian 71 68 71 66 276
Native Hawaiian or Other Pacific Islander 2 2 2 3 9
Black or African American 55 48 47 51 201
White 450 447 452 443 1792
More than one race 7 9 6 8 30
Unknown or Not Reported 0 0 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 643 participants 630 participants 636 participants 630 participants 2539 participants
Argentina 93 90 90 91 364
United States 288 282 287 284 1141
Japan 33 30 30 31 124
China 7 9 7 7 30
Taiwan 15 12 15 16 58
Brazil 59 59 61 60 239
Mexico 108 110 107 108 433
Russia 32 29 30 27 118
India 8 9 9 6 32
Baseline Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 643 participants 630 participants 636 participants 630 participants 2539 participants
104.9  (21.37) 102.88  (20.71) 105.84  (23.32) 105.59  (22.92) 104.78  (22.12)
1.Primary Outcome
Title Percent Change From Baseline in Body Weight
Hide Description Least Squares (LS) Mean was calculated using mixed-model repeated measures (MMRM) with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Time Frame Baseline, Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value, excluding data after prematurely stopping study drug.
Arm/Group Title Placebo 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide
Hide Arm/Group Description:
Placebo administered SC once a week.
5 mg tirzepatide administered SC once a week.
10 mg tirzepatide administered SC once a week.
15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 635 623 629 625
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-2.4  (0.40) -16.0  (0.39) -21.4  (0.39) -22.5  (0.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 5 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square (LS) Mean Difference (Net)
Estimated Value -13.5
Confidence Interval (2-Sided) 95%
-14.6 to -12.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference (Net)
Estimated Value -18.9
Confidence Interval (2-Sided) 95%
-20.0 to -17.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 15 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference (Net)
Estimated Value -20.1
Confidence Interval (2-Sided) 95%
-21.2 to -19.0
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Hide Description Percentage of participants who achieve ≥5% body weight reduction.
Time Frame Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥5% Body Weight Reduction, excluding data after prematurely stopping study drug.
Arm/Group Title Placebo 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide
Hide Arm/Group Description:
Placebo administered SC once a week.
5 mg tirzepatide administered SC once a week.
10 mg tirzepatide administered SC once a week.
15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 635 623 629 625
Measure Type: Number
Unit of Measure: Percentage of Participants
27.87 89.41 96.18 96.32
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 5 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 23.99
Confidence Interval (2-Sided) 95%
17.43 to 33.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 73.63
Confidence Interval (2-Sided) 95%
46.98 to 115.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 15 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 75.48
Confidence Interval (2-Sided) 95%
47.86 to 119.03
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg)
Hide Description LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Time Frame Baseline, Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 10 mg and 15 mg tirzepatide.
Arm/Group Title Placebo Pooled 10 mg/15 mg Tirzepatide
Hide Arm/Group Description:
Placebo administered SC once a week.
10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 635 1254
Least Squares Mean (Standard Error)
Unit of Measure: kilograms
-2.5  (0.22) -13.2  (0.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pooled 10 mg/15 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference (Net)
Estimated Value -10.7
Confidence Interval (2-Sided) 95%
-11.2 to -10.1
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percent Change From Baseline in Body Weight
Hide Description Percent Change from Baseline in Body Weight.
Time Frame Baseline, Week 176
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Hide Description Percentage of Participants who Achieve ≥10% Body Weight Reduction
Time Frame Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥10% Body Weight Reduction, excluding data after prematurely stopping study drug.
Arm/Group Title Placebo 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide
Hide Arm/Group Description:
Placebo administered SC once a week.
5 mg tirzepatide administered SC once a week.
10 mg tirzepatide administered SC once a week.
15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 635 623 629 625
Measure Type: Number
Unit of Measure: Percentage of Participants
13.54 73.35 85.85 90.08
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 5 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 19.03
Confidence Interval (2-Sided) 95%
14.15 to 25.60
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 44.17
Confidence Interval (2-Sided) 95%
31.75 to 61.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 15 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 65.64
Confidence Interval (2-Sided) 95%
45.94 to 93.77
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Hide Description Percentage of participants who achieve ≥15% body weight reduction.
Time Frame Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥15% body weight reduction, excluding data after prematurely stopping study drug.
Arm/Group Title Placebo 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide
Hide Arm/Group Description:
Placebo administered SC once a week.
5 mg tirzepatide administered SC once a week.
10 mg tirzepatide administered SC once a week.
15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 635 623 629 625
Measure Type: Number
Unit of Measure: Percentage of Participants
5.98 50.24 73.61 78.24
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 5 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 17.08
Confidence Interval (2-Sided) 95%
11.83 to 24.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 51.84
Confidence Interval (2-Sided) 95%
35.42 to 75.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 15 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 66.63
Confidence Interval (2-Sided) 95%
45.23 to 98.16
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Hide Description Percentage of Participants who Achieve ≥5% Body Weight Reduction.
Time Frame Week 176
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Percentage of Participants Who Achieve ≥20% Body Weight Reduction
Hide Description Percentage of participants who achieve ≥20% body weight reduction.
Time Frame Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥20% Body Weight Reduction, excluding data after prematurely stopping study drug.
Arm/Group Title Placebo 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide
Hide Arm/Group Description:
Placebo administered SC once a week.
5 mg tirzepatide administered SC once a week.
10 mg tirzepatide administered SC once a week.
15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 635 623 629 625
Measure Type: Number
Unit of Measure: Percentage of Participants
1.26 31.62 55.48 62.88
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 5 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 36.93
Confidence Interval (2-Sided) 95%
18.37 to 74.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 109.45
Confidence Interval (2-Sided) 95%
54.50 to 219.81
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 15 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 150.59
Confidence Interval (2-Sided) 95%
74.85 to 302.97
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Waist Circumference
Hide Description LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Time Frame Baseline, Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had baseline and at least one post-baseline weight circumference value, excluding data after prematurely stopping study drug.
Arm/Group Title Placebo 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide
Hide Arm/Group Description:
Placebo administered SC once a week.
5 mg tirzepatide administered SC once a week.
10 mg tirzepatide administered SC once a week.
15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 634 622 629 625
Least Squares Mean (Standard Error)
Unit of Measure: centimeters
-3.4  (0.42) -14.6  (0.41) -19.4  (0.41) -19.9  (0.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 5 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference (Net)
Estimated Value -11.2
Confidence Interval (2-Sided) 95%
-12.3 to -10.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference (Net)
Estimated Value -16.0
Confidence Interval (2-Sided) 95%
-17.2 to -14.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 15 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference (Net)
Estimated Value -16.5
Confidence Interval (2-Sided) 95%
-17.7 to -15.4
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Body Mass Index (BMI)
Hide Description LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Time Frame Baseline, Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had baseline and at least one post-baseline BMI value, excluding data after prematurely stopping study drug.
Arm/Group Title Placebo 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide
Hide Arm/Group Description:
Placebo administered SC once a week.
5 mg tirzepatide administered SC once a week.
10 mg tirzepatide administered SC once a week.
15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 635 623 629 625
Least Squares Mean (Standard Error)
Unit of Measure: kilograms per meter squared (kg/m^2)
-0.9  (0.16) -5.9  (0.16) -8.1  (0.16) -8.6  (0.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 5 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference (Net)
Estimated Value -5.1
Confidence Interval (2-Sided) 95%
-5.5 to -4.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference (Net)
Estimated Value -7.2
Confidence Interval (2-Sided) 95%
-7.7 to -6.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 15 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference (Net)
Estimated Value -7.7
Confidence Interval (2-Sided) 95%
-8.2 to -7.3
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Fasting Glucose
Hide Description LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Time Frame Baseline, Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had baseline and at least one post-baseline fasting glucose value, excluding data after prematurely stopping study drug.
Arm/Group Title Placebo 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide
Hide Arm/Group Description:
Placebo administered SC once a week.
5 mg tirzepatide administered SC once a week.
10 mg tirzepatide administered SC once a week.
15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 612 608 606 608
Least Squares Mean (Standard Error)
Unit of Measure: milligram per deciliter (mg/dL)
0.86  (0.514) -7.73  (0.484) -9.73  (0.486) -10.55  (0.486)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 5 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference (Net)
Estimated Value -8.59
Confidence Interval (2-Sided) 95%
-9.97 to -7.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference (Net)
Estimated Value -10.59
Confidence Interval (2-Sided) 95%
-11.98 to -9.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 15 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference (Net)
Estimated Value -11.42
Confidence Interval (2-Sided) 95%
-12.80 to -10.30
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percent Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Hide Description Fasting Insulin is a test used to measure the amount of insulin in the body. Results are reported as model-based estimates and SE from MMRM analysis using log transformation.
Time Frame Baseline, Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had a baseline and at least one post-baseline fasting insulin value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.
Arm/Group Title Placebo Pooled 5 mg/10 mg/15 mg Tirzepatide
Hide Arm/Group Description:
Placebo administered SC once a week.
5 mg tirzepatide administered SC once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 590 1779
Mean (Standard Error)
Unit of Measure: percent change
-9.7  (2.60) -46.9  (0.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pooled 5 mg/10 mg/15 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate Difference
Estimated Value -41.2
Confidence Interval (2-Sided) 95%
-44.9 to -37.3
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Time to Onset of Type 2 Diabetes
Hide Description Time to Onset of Type 2 Diabetes
Time Frame Baseline through Week 176
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Change From Baseline in Hemoglobin A1c (HbA1c)
Hide Description HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Time Frame Baseline, Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had baseline and at least one post-baseline HbA1c value, excluding data after prematurely stopping study drug.
Arm/Group Title Placebo 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide
Hide Arm/Group Description:
Placebo administered SC once a week.
5 mg tirzepatide administered SC once a week.
10 mg tirzepatide administered SC once a week.
15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 612 607 607 608
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of HbA1c
-0.07  (0.012) -0.40  (0.012) -0.49  (0.012) -0.51  (0.012)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 5 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference (Net)
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-0.36 to -0.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference (Net)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-0.45 to -0.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 15 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference (Net)
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-0.48 to -0.41
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Hide Description Percent change from baseline in triglycerides are reported as model-based estimate and Standard Error (SE) from MMRM analysis using log transformation.
Time Frame Baseline, Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had a baseline and at least one post-baseline triglyceride value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.
Arm/Group Title Placebo Pooled 5 mg/10 mg/15 mg Tirzepatide
Hide Arm/Group Description:
Placebo administered SC once a week.
5 mg tirzepatide administered SC once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 612 1822
Mean (Standard Error)
Unit of Measure: percent change
-6.3  (1.55) -27.6  (0.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pooled 5 mg/10 mg/15 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate Difference
Estimated Value -22.7
Confidence Interval (2-Sided) 95%
-25.6 to -19.8
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percent Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Hide Description Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Time Frame Baseline, Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had a baseline and at least one post-baseline LDL value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.
Arm/Group Title Placebo Pooled 5 mg/10 mg/15 mg Tirzepatide
Hide Arm/Group Description:
Placebo administered SC once a week.
5 mg tirzepatide administered SC once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 578 1754
Mean (Standard Error)
Unit of Measure: percent change
-0.85  (1.076) -6.86  (0.555)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pooled 5 mg/10 mg/15 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate Difference
Estimated Value -6.06
Confidence Interval (2-Sided) 95%
-8.32 to -3.75
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Hide Description Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Time Frame Baseline, Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had baseline and at least one post-baseline total cholesterol value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.
Arm/Group Title Placebo Pooled 5 mg/10 mg/15 mg Tirzepatide
Hide Arm/Group Description:
Placebo administered SC once a week.
5 mg tirzepatide administered SC once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 612 1822
Mean (Standard Error)
Unit of Measure: percent change
-1.11  (0.695) -5.97  (0.364)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pooled 5 mg/10 mg/15 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate Difference
Estimated Value -4.91
Confidence Interval (2-Sided) 95%
-6.40 to -3.41
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72 (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Hide Description Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Time Frame Baseline, Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had baseline and at least one post-baseline total cholesterol HDL value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.
Arm/Group Title Placebo Pooled 5 mg/10 mg/15 mg Tirzepatide
Hide Arm/Group Description:
Placebo administered SC once a week.
5 mg tirzepatide administered SC once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 581 1764
Mean (Standard Error)
Unit of Measure: percent change
0.25  (0.757) 7.92  (0.447)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pooled 5 mg/10 mg/15 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate Difference
Estimated Value 7.65
Confidence Interval (2-Sided) 95%
5.85 to 9.49
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Hide Description Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Time Frame Baseline, Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had baseline and at least one post-baseline VLDL value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.
Arm/Group Title Placebo Pooled 5 mg/10 mg/15 mg Tirzepatide
Hide Arm/Group Description:
Placebo administered SC once a week.
5 mg tirzepatide administered SC once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 577 1754
Mean (Standard Error)
Unit of Measure: percent change
-5.6  (1.55) -27.6  (0.65)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pooled 5 mg/10 mg/15 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate Difference
Estimated Value -23.3
Confidence Interval (2-Sided) 95%
-26.1 to -20.4
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Percent Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Hide Description Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Time Frame Baseline, Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had baseline and at least one post-baseline free fatty acids value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.
Arm/Group Title Placebo Pooled 5 mg/10 mg/15 mg Tirzepatide
Hide Arm/Group Description:
Placebo administered SC once a week.
5 mg tirzepatide administered SC once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 576 1756
Mean (Standard Error)
Unit of Measure: percent change
6.1  (2.65) -5.9  (1.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pooled 5 mg/10 mg/15 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate Difference
Estimated Value -11.3
Confidence Interval (2-Sided) 95%
-16.1 to -6.2
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Hide Description LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Time Frame Baseline, Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had baseline and at least one post-baseline SBP value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.
Arm/Group Title Placebo Pooled 5 mg/10 mg/15 mg Tirzepatide
Hide Arm/Group Description:
Placebo administered SC once a week.
5 mg tirzepatide administered SC once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 634 1878
Least Squares Mean (Standard Error)
Unit of Measure: millimeter of mercury (mmHg)
-1.3  (0.48) -8.1  (0.27)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pooled 5 mg/10 mg/15 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference (Net)
Estimated Value -6.8
Confidence Interval (2-Sided) 95%
-7.9 to -5.7
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Hide Description LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Time Frame Baseline, Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had baseline and at least one post-baseline DBP value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.
Arm/Group Title Placebo Pooled 5 mg/10 mg/15 mg Tirzepatide
Hide Arm/Group Description:
Placebo administered SC once a week.
5 mg tirzepatide administered SC once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 634 1878
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-1.0  (0.35) -5.3  (0.19)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pooled 5 mg/10 mg/15 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference (Net)
Estimated Value -4.2
Confidence Interval (2-Sided) 95%
-5.0 to -3.5
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Change From Baseline in Short Form Survey-36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 72 (Pooled Doses of Tirzepatide 10 mg and 15 mg)
Hide Description The SF-36v2 acute, 1-week recall version is a 36-item, generic, patient-administered measure designed to assess the following 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" while the remaining domains assess functioning "in the past week." Each domain is scored individually and information from these 8 domains are further aggregated into 2 health-component summary scores: Physical-Component Summary and Mental-Component Summary. Items are answered on Likert scales of varying lengths (3-, 5-, or 6- point scales).The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.
Time Frame Baseline, Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had baseline and at least one post-baseline SF-36v2 value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 10 mg and 15 mg tirzepatide.
Arm/Group Title Placebo Pooled 10 mg/15 mg Tirzepatide
Hide Arm/Group Description:
Placebo administered SC once a week.
10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 482 1080
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
1.7  (0.27) 4.0  (0.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pooled 10 mg/15 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference (Net)
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
1.6 to 2.9
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72
Hide Description The IWQOL-Lite-CT is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (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. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life.
Time Frame Baseline, Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had baseline and at least one post-baseline IWQOL-Lite CT value, excluding data after prematurely stopping study drug.
Arm/Group Title Placebo 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide
Hide Arm/Group Description:
Placebo administered SC once a week.
5 mg tirzepatide administered SC once a week.
10 mg tirzepatide administered SC once a week.
15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 477 545 539 535
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
10.1  (0.78) 17.8  (0.73) 20.7  (0.73) 21.8  (0.73)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 5 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference (Net)
Estimated Value 7.7
Confidence Interval (2-Sided) 95%
5.6 to 9.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference (Net)
Estimated Value 10.7
Confidence Interval (2-Sided) 95%
8.6 to 12.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 15 mg Tirzepatide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference (Net)
Estimated Value 11.7
Confidence Interval (2-Sided) 95%
9.6 to 13.8
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide
Hide Description PK: Steady State AUC of Tirzepatide. each participant will be assigned via the Interactive Web Response System (IWRS) to one of the sampling PK time windows of 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose.
Time Frame Week 8, 16, and 36, at 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomly assigned participants who are exposed to at least one dose of study drug who had evaluable PK data.
Arm/Group Title 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide
Hide Arm/Group Description:
5 mg tirzepatide administered SC once a week.
10 mg tirzepatide administered SC once a week.
15 mg tirzepatide administered SC once a week.
Overall Number of Participants Analyzed 626 629 625
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hours per milliliter (ng*h/mL)
88900
(20.2%)
177000
(22.0%)
266000
(20.4%)
Time Frame Baseline through Week 86
Adverse Event Reporting Description

Data obtained during the treatment period plus safety follow-up period from mITT, regardless of adherence to study drug.

mITT population: All randomly assigned participants who are exposed to at least 1 dose of study drug. Participants will be included in the treatment group they were randomized to.

Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
 
Arm/Group Title Placebo 5 Milligrams (mg) Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide
Hide Arm/Group Description Placebo administered subcutaneously (SC) once a week. 5 mg tirzepatide administered SC once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week.
All-Cause Mortality
Placebo 5 Milligrams (mg) Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/643 (0.62%)      4/630 (0.63%)      2/636 (0.31%)      1/630 (0.16%)    
Hide Serious Adverse Events
Placebo 5 Milligrams (mg) Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/643 (6.84%)      40/630 (6.35%)      44/636 (6.92%)      32/630 (5.08%)    
Cardiac disorders         
Acute coronary syndrome † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Acute myocardial infarction † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Angina unstable † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Atrial fibrillation † 1  1/643 (0.16%)  1 0/630 (0.00%)  0 0/636 (0.00%)  0 0/630 (0.00%)  0
Cardiac failure acute † 1  1/643 (0.16%)  1 0/630 (0.00%)  0 0/636 (0.00%)  0 0/630 (0.00%)  0
Coronary artery disease † 1  1/643 (0.16%)  1 0/630 (0.00%)  0 0/636 (0.00%)  0 0/630 (0.00%)  0
Myocardial infarction † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Ear and labyrinth disorders         
Vertigo † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Gastrointestinal disorders         
Chronic gastritis † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 0/636 (0.00%)  0 1/630 (0.16%)  1
Colitis † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 0/636 (0.00%)  0 1/630 (0.16%)  2
Colitis ulcerative † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Constipation † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Duodenal ulcer † 1  1/643 (0.16%)  1 0/630 (0.00%)  0 0/636 (0.00%)  0 0/630 (0.00%)  0
Enteritis † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Gastric antral vascular ectasia † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 0/636 (0.00%)  0 1/630 (0.16%)  1
Ileus paralytic † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Intestinal obstruction † 1  1/643 (0.16%)  1 0/630 (0.00%)  0 0/636 (0.00%)  0 0/630 (0.00%)  0
Obstructive pancreatitis † 1  1/643 (0.16%)  1 0/630 (0.00%)  0 0/636 (0.00%)  0 0/630 (0.00%)  0
Oesophagitis ulcerative † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 0/636 (0.00%)  0 1/630 (0.16%)  1
Pancreatitis † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 0/636 (0.00%)  0 1/630 (0.16%)  1
Pancreatitis acute † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Proctitis † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Retroperitoneal haematoma † 1  1/643 (0.16%)  1 0/630 (0.00%)  0 0/636 (0.00%)  0 0/630 (0.00%)  0
Vomiting † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 1/630 (0.16%)  1
General disorders         
Chest pain † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Non-cardiac chest pain † 1  1/643 (0.16%)  1 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Hepatobiliary disorders         
Bile duct stone † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 0/636 (0.00%)  0 1/630 (0.16%)  1
Biliary obstruction † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 0/636 (0.00%)  0 1/630 (0.16%)  1
Cholangitis acute † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 0/636 (0.00%)  0 1/630 (0.16%)  1
Cholecystitis † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 2/636 (0.31%)  2 0/630 (0.00%)  0
Cholecystitis acute † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 2/636 (0.31%)  2 1/630 (0.16%)  1
Cholecystitis chronic † 1  3/643 (0.47%)  3 0/630 (0.00%)  0 1/636 (0.16%)  1 1/630 (0.16%)  1
Cholelithiasis † 1  3/643 (0.47%)  3 3/630 (0.48%)  3 4/636 (0.63%)  4 3/630 (0.48%)  3
Hepatic failure † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Sphincter of oddi dysfunction † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Infections and infestations         
Abdominal abscess † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Anal abscess † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 0/636 (0.00%)  0 1/630 (0.16%)  1
Appendicitis † 1  3/643 (0.47%)  3 4/630 (0.63%)  4 0/636 (0.00%)  0 2/630 (0.32%)  2
Bacterial colitis † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Cellulitis † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 0/636 (0.00%)  0 1/630 (0.16%)  1
Coronavirus infection † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Coronavirus pneumonia † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Covid-19 † 1  6/643 (0.93%)  6 1/630 (0.16%)  1 6/636 (0.94%)  6 1/630 (0.16%)  1
Covid-19 pneumonia † 1  4/643 (0.62%)  4 6/630 (0.95%)  6 3/636 (0.47%)  3 3/630 (0.48%)  3
Diverticulitis † 1  1/643 (0.16%)  1 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Gastroenteritis † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  2 0/630 (0.00%)  0
Influenza † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Pelvic inflammatory disease † 1  0/436 (0.00%)  0 0/426 (0.00%)  0 0/427 (0.00%)  0 1/425 (0.24%)  1
Peritoneal tuberculosis † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  2 0/630 (0.00%)  0
Peritonsillar abscess † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Pneumonia † 1  0/643 (0.00%)  0 3/630 (0.48%)  3 0/636 (0.00%)  0 0/630 (0.00%)  0
Pneumonia aspiration † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 0/636 (0.00%)  0 1/630 (0.16%)  1
Pneumonia bacterial † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Pyelonephritis † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 1/630 (0.16%)  1
Septic shock † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Urinary tract infection † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 1/636 (0.16%)  1 0/630 (0.00%)  0
Injury, poisoning and procedural complications         
Ankle fracture † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Contusion † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Facial bones fracture † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Foot fracture † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Lumbar vertebral fracture † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Multiple injuries † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Procedural pain † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Road traffic accident † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Tibia fracture † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Wound † 1  1/643 (0.16%)  1 0/630 (0.00%)  0 0/636 (0.00%)  0 0/630 (0.00%)  0
Investigations         
Sars-cov-2 test positive † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 1/630 (0.16%)  1
Musculoskeletal and connective tissue disorders         
Osteoarthritis † 1  2/643 (0.31%)  2 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Vertebral foraminal stenosis † 1  1/643 (0.16%)  1 0/630 (0.00%)  0 0/636 (0.00%)  0 0/630 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Adenocarcinoma of the cervix † 1  1/436 (0.23%)  1 0/426 (0.00%)  0 0/427 (0.00%)  0 0/425 (0.00%)  0
Adenosquamous carcinoma of the cervix † 1  0/436 (0.00%)  0 0/426 (0.00%)  0 0/427 (0.00%)  0 1/425 (0.24%)  1
Breast cancer † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 0/636 (0.00%)  0 1/630 (0.16%)  1
Endometrial cancer † 1  0/436 (0.00%)  0 1/426 (0.23%)  1 0/427 (0.00%)  0 0/425 (0.00%)  0
Intraductal proliferative breast lesion † 1  1/643 (0.16%)  1 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Leiomyoma † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 0/636 (0.00%)  0 1/630 (0.16%)  1
Lung adenocarcinoma † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 0/636 (0.00%)  0 1/630 (0.16%)  1
Malignant melanoma † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 1/636 (0.16%)  1 0/630 (0.00%)  0
Meningioma † 1  1/643 (0.16%)  1 0/630 (0.00%)  0 1/636 (0.16%)  1 1/630 (0.16%)  1
Ovarian cancer † 1  1/436 (0.23%)  1 0/426 (0.00%)  0 0/427 (0.00%)  0 0/425 (0.00%)  0
Ovarian germ cell endodermal sinus tumour stage i † 1  0/436 (0.00%)  0 1/426 (0.23%)  1 0/427 (0.00%)  0 0/425 (0.00%)  0
Pancreatic carcinoma metastatic † 1  1/643 (0.16%)  1 0/630 (0.00%)  0 0/636 (0.00%)  0 0/630 (0.00%)  0
Papillary thyroid cancer † 1  1/643 (0.16%)  1 0/630 (0.00%)  0 0/636 (0.00%)  0 0/630 (0.00%)  0
Plasma cell myeloma † 1  1/643 (0.16%)  1 0/630 (0.00%)  0 0/636 (0.00%)  0 0/630 (0.00%)  0
Prostate cancer † 1  1/207 (0.48%)  1 1/204 (0.49%)  1 0/209 (0.00%)  0 0/205 (0.00%)  0
Renal cancer † 1  1/643 (0.16%)  1 0/630 (0.00%)  0 0/636 (0.00%)  0 0/630 (0.00%)  0
Uterine leiomyoma † 1  0/436 (0.00%)  0 0/426 (0.00%)  0 0/427 (0.00%)  0 1/425 (0.24%)  1
Nervous system disorders         
Brain oedema † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Cerebrovascular accident † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Dizziness † 1  1/643 (0.16%)  1 0/630 (0.00%)  0 0/636 (0.00%)  0 0/630 (0.00%)  0
Encephalopathy † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 0/636 (0.00%)  0 1/630 (0.16%)  1
Hypoaesthesia † 1  1/643 (0.16%)  1 0/630 (0.00%)  0 0/636 (0.00%)  0 0/630 (0.00%)  0
Idiopathic generalised epilepsy † 1  1/643 (0.16%)  1 0/630 (0.00%)  0 0/636 (0.00%)  0 0/630 (0.00%)  0
Ischaemic stroke † 1  1/643 (0.16%)  1 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Multiple sclerosis relapse † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 0/636 (0.00%)  0 1/630 (0.16%)  1
Thalamus haemorrhage † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Vertebrobasilar stroke † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous † 1  0/436 (0.00%)  0 1/426 (0.23%)  1 0/427 (0.00%)  0 0/425 (0.00%)  0
Ectopic pregnancy † 1  0/436 (0.00%)  0 1/426 (0.23%)  1 0/427 (0.00%)  0 0/425 (0.00%)  0
Product Issues         
Device dislocation † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Psychiatric disorders         
Adjustment disorder with mixed anxiety and depressed mood † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Anxiety disorder † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Bulimia nervosa † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Major depression † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Substance abuse † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Suicide attempt † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  2 1/630 (0.16%)  1
Renal and urinary disorders         
Acute kidney injury † 1  1/643 (0.16%)  2 2/630 (0.32%)  2 1/636 (0.16%)  1 0/630 (0.00%)  0
Nephrolithiasis † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 0/636 (0.00%)  0 1/630 (0.16%)  1
Renal failure † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Renal mass † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 0/636 (0.00%)  0 1/630 (0.16%)  1
Reproductive system and breast disorders         
Cystocele † 1  0/436 (0.00%)  0 0/426 (0.00%)  0 1/427 (0.23%)  1 0/425 (0.00%)  0
Endometrial hyperplasia † 1  0/436 (0.00%)  0 0/426 (0.00%)  0 1/427 (0.23%)  1 0/425 (0.00%)  0
Rectocele † 1  0/436 (0.00%)  0 0/426 (0.00%)  0 1/427 (0.23%)  1 0/425 (0.00%)  0
Uterine prolapse † 1  0/436 (0.00%)  0 0/426 (0.00%)  0 1/427 (0.23%)  1 0/425 (0.00%)  0
Vaginal haemorrhage † 1  1/436 (0.23%)  1 0/426 (0.00%)  0 0/427 (0.00%)  0 0/425 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Acute respiratory failure † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 1/636 (0.16%)  1 0/630 (0.00%)  0
Aspiration † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Asthma † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Chronic obstructive pulmonary disease † 1  0/643 (0.00%)  0 1/630 (0.16%)  1 0/636 (0.00%)  0 0/630 (0.00%)  0
Dyspnoea † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Pneumonitis † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Pulmonary embolism † 1  3/643 (0.47%)  3 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Social circumstances         
Homicide † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Surgical and medical procedures         
Thyroidectomy † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 0/636 (0.00%)  0 1/630 (0.16%)  1
Vascular disorders         
Deep vein thrombosis † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 0/630 (0.00%)  0
Hypertension † 1  2/643 (0.31%)  2 0/630 (0.00%)  0 0/636 (0.00%)  0 0/630 (0.00%)  0
Hypertensive urgency † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 0/636 (0.00%)  0 1/630 (0.16%)  1
Hypotension † 1  0/643 (0.00%)  0 0/630 (0.00%)  0 1/636 (0.16%)  1 1/630 (0.16%)  1
Thrombophlebitis † 1  1/643 (0.16%)  1 0/630 (0.00%)  0 0/636 (0.00%)  0 0/630 (0.00%)  0
1
Term from vocabulary, MedDRA 24.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo 5 Milligrams (mg) Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   237/643 (36.86%)      401/630 (63.65%)      422/636 (66.35%)      399/630 (63.33%)    
Gastrointestinal disorders         
Abdominal pain † 1  21/643 (3.27%)  25 31/630 (4.92%)  45 34/636 (5.35%)  51 31/630 (4.92%)  56
Constipation † 1  37/643 (5.75%)  46 106/630 (16.83%)  121 109/636 (17.14%)  130 74/630 (11.75%)  94
Diarrhoea † 1  47/643 (7.31%)  82 118/630 (18.73%)  186 135/636 (21.23%)  256 145/630 (23.02%)  277
Dyspepsia † 1  27/643 (4.20%)  30 56/630 (8.89%)  82 62/636 (9.75%)  75 71/630 (11.27%)  119
Eructation † 1  4/643 (0.62%)  4 24/630 (3.81%)  31 33/636 (5.19%)  34 35/630 (5.56%)  99
Nausea † 1  61/643 (9.49%)  97 155/630 (24.60%)  294 212/636 (33.33%)  475 195/630 (30.95%)  435
Vomiting † 1  11/643 (1.71%)  12 52/630 (8.25%)  74 68/636 (10.69%)  113 77/630 (12.22%)  135
General disorders         
Injection site reaction † 1  2/643 (0.31%)  2 18/630 (2.86%)  175 36/636 (5.66%)  229 29/630 (4.60%)  223
Infections and infestations         
Covid-19 † 1  84/643 (13.06%)  91 93/630 (14.76%)  96 92/636 (14.47%)  94 82/630 (13.02%)  84
Metabolism and nutrition disorders         
Decreased appetite † 1  21/643 (3.27%)  23 59/630 (9.37%)  63 73/636 (11.48%)  85 54/630 (8.57%)  71
Nervous system disorders         
Dizziness † 1  14/643 (2.18%)  15 26/630 (4.13%)  30 35/636 (5.50%)  39 26/630 (4.13%)  31
Headache † 1  42/643 (6.53%)  47 41/630 (6.51%)  49 43/636 (6.76%)  56 41/630 (6.51%)  51
Skin and subcutaneous tissue disorders         
Alopecia † 1  6/643 (0.93%)  6 32/630 (5.08%)  33 31/636 (4.87%)  31 36/630 (5.71%)  36
1
Term from vocabulary, MedDRA 24.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-595-5979
EMail: ClinicalTrials.gov@lilly.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04184622    
Other Study ID Numbers: 17244
I8F-MC-GPHK ( Other Identifier: Eli Lilly and Company )
First Submitted: December 2, 2019
First Posted: December 3, 2019
Results First Submitted: March 30, 2023
Results First Posted: April 24, 2023
Last Update Posted: April 18, 2024