A Study of Tirzepatide (LY3298176) In Participants After... | NCT04657016

ID	Type	Description	Link
I8F-MC-GPHM	Other Identifier	Eli Lilly and Company

Status Module

Label	Type	Description	Intervention Names
Tirzepatide	Experimental	Participants received weekly doses of tirzepatide subcutaneously (SC) for 72 weeks, starting at 2.5 milligrams (mg) for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg.	Drug: Tirzepatide
Placebo	Placebo Comparator	Participants received matching placebo SC once weekly (QW).	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Tirzepatide	Drug	Administered SC	Tirzepatide	LY3298176

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in Body Weight	Percent change from baseline in body weight. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment*Time (Type III sum of squares).	Baseline, 72 Weeks
Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction	Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression model using imputed data with baseline body weight, Analysis Country, Sex, Treatment as factors.	Week 72

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program	Percentage of participants who maintain ≥80% of the body weight lost during intensive lifestyle program was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.	72 Weeks

Eligibility Module

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
National Research Institute - Huntington Park		Huntington Park	California	90255	United States
National Research Institute - Wilshire

PubMed Identifier	Type	Citation	Retractions
41885866	Derived	Galindo RJ, Gudzune KA, Look M, Lee CJ, Benabbad I, Cao D, Meng Q, Mojdami D. Weight Changes With Tirzepatide and Concomitant Weight-Inducing Medications: Post Hoc Analysis of Randomized Clinical Trials. JAMA Netw Open. 2026 Mar 2;9(3):e263274. doi: 10.1001/jamanetworkopen.2026.3274.
41640675	Derived	Almandoz JP, Pickett-Blakely O, Tewksbury C, Stefanski A, Gonsahn-Bollie S, Dimitriadis GK, Murro AL, Cao D, Meng Q, Neff LM. Nutritional status with tirzepatide in obesity: A post hoc analysis of the SURMOUNT-1-4 randomized clinical trials. Obes Pillars. 2026 Jan 23;17:100248. doi: 10.1016/j.obpill.2026.100248. eCollection 2026 Mar.

Label	URL
A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program (SURMOUNT-3)	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received matching placebo subcutaneously (SC) once weekly (QW).
FG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 milligrams (mg) for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 19, 2020	Mar 22, 2024

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent Change From Baseline in Body Weight

Percent change from baseline in body weight. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment*Time (Type III sum of squares).

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, 72 Weeks

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC once weekly QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Units	Counts
Participants	OG000291 OG001284

Title

Denominators

Categories

Title	Measurements
	OG0003.3± 0.60 OG001-21.1± 0.59

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis		<0.001		Mean Difference (Net)	-24.5			2-Sided	95	-26.1	-22.8					Superiority

Primary

Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction

Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression model using imputed data with baseline body weight, Analysis Country, Sex, Treatment as factors.

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Number

percentage of participants

Week 72

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC once weekly QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program

Percentage of participants who maintain ≥80% of the body weight lost during intensive lifestyle program was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Number

percentage of participants

72 Weeks

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC once weekly QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Units	Counts
Participants

Secondary

Percentage of Participants Who Achieve ≥10%Body Weight Reduction

Percentage of participants who achieve ≥10% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Number

percentage of participants

72 Weeks

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC once weekly QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Achieve ≥15% Body Weight Reduction

Percentage of participants who achieve ≥15% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Number

Percentage of participants

72 Weeks

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC once weekly QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Achieve ≥20% Body Weight Reduction

Percentage of participants who achieve ≥20% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Number

Percentage of participants

72 Weeks

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC once weekly QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Waist Circumference

Change from baseline in waist circumference. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Least Squares Mean

Standard Error

Centimeters (Cms)

Baseline, 72 Weeks

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC once weekly QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Body Weight

Change from baseline in body weight. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment*Time (Type III sum of squares).

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Least Squares Mean

Standard Error

Baseline, 72 Weeks

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC once weekly QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Body Mass Index (BMI)

Change from baseline in BMI. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment*Time (Type III sum of squares).

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Least Squares Mean

Standard Error

kilogram per meter square (kg/m^2)

Baseline, 72 Weeks

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC once weekly QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Systolic Blood Pressure (SBP)

Change from baseline in SBP. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Least Squares Mean

Standard Error

millimeters of mercury (mmHg)

Baseline, 72 Weeks

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Diastolic Blood Pressure (DBP)

Change from baseline in DBP. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline, 72 Weeks

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Total Cholesterol

Percent change from baseline in total cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, 72 Weeks

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Units	Counts
Participants

Secondary

Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol

Percent change from baseline in HDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, 72 Weeks

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Units	Counts
Participants

Secondary

Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol

Percent change from baseline in LDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, 72 Weeks

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Units	Counts
Participants

Secondary

Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol

Percent change from baseline in VLDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, 72 Weeks

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Units	Counts
Participants

Secondary

Percent Change From Baseline in Triglycerides

Percent change from baseline in triglycerides. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, 72 Weeks

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Units	Counts
Participants

Secondary

Percent Change From Baseline in Free Fatty Acids

Percent change from baseline in free fatty acids. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, 72 Weeks

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Units	Counts
Participants

Secondary

Change From Baseline in Fasting Glucose

Change from baseline in fasting glucose. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Least Squares Mean

Standard Error

Milligram per deciliter (mg/dL)

Baseline, 72 Weeks

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Hemoglobin A1c (HbA1c)

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Least Squares Mean

Standard Deviation

Percentage of HbA1c

Baseline, 72 Weeks

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Units	Counts
Participants

Secondary

Percent Change From Baseline in Fasting Insulin

Percent change from baseline in fasting insulin. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, 72 Weeks

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Units	Counts
Participants

Secondary

Change From Baseline in Short Form 36 Version 2 Health Survey Version 2 (SF 36v2) Acute Form Physical Functioning Domain Score

The SF-36v2 acute form assesses 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. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is 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. Range cannot be specified in norm-based scores.

LS mean was determined using analysis of covariance (ANCOVA) model using Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment (Type III sum of squares) as variables.

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Least Squares Mean

Standard Error

T-score

Baseline, 72 Weeks

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Secondary

Change From Baseline in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score

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. 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 health-related quality of life.

LS mean was determined using ANCOVA model with Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment (Type III sum of squares) as variables.

All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, 72 Weeks

ID	Title	Description
OG000	Placebo	Participants received matching placebo SC QW.
OG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected292 at risk EG0011 events1 affected287 at risk
Myocardial infarction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected292 at risk EG0010 events0 affected287 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected292 at risk EG0010 events0 affected287 at risk
Colitis microscopic	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected292 at risk EG0011 events1 affected287 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected292 at risk EG0011 events1 affected287 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected292 at risk EG0010 events0 affected287 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected292 at risk EG0011 events1 affected287 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected292 at risk EG0010 events0 affected287 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected292 at risk EG0011 events1 affected287 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected292 at risk EG0011 events1 affected287 at risk
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected292 at risk EG0010 events0 affected287 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected292 at risk EG0011 events1 affected287 at risk
Appendicitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected292 at risk EG0010 events0 affected287 at risk
Cellulitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected292 at risk EG0011 events1 affected287 at risk
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected292 at risk EG0010 events0 affected287 at risk
Pyelonephritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected292 at risk EG0010 events0 affected287 at risk
Sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected292 at risk EG0011 events1 affected287 at risk
Toxoplasmosis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected292 at risk EG0011 events1 affected287 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events1 affected292 at risk EG0010 events0 affected287 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected292 at risk EG0010 events0 affected287 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected292 at risk EG0011 events1 affected287 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected292 at risk EG0011 events1 affected287 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected292 at risk EG0011 events1 affected287 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected292 at risk EG0010 events0 affected287 at risk
Colorectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected292 at risk EG0011 events1 affected287 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected292 at risk EG0011 events1 affected287 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected292 at risk EG0011 events1 affected287 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected292 at risk EG0011 events1 affected287 at risk
Anembryonic gestation	Pregnancy, puerperium and perinatal conditions	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected292 at risk EG0011 events1 affected287 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected292 at risk EG0011 events1 affected287 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected292 at risk EG0010 events0 affected287 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected292 at risk EG0010 events0 affected287 at risk
Pulmonary thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected292 at risk EG0010 events0 affected287 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00010 events7 affected292 at risk EG00138 events30 affected287 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00024 events20 affected292 at risk EG00189 events66 affected287 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00053 events27 affected292 at risk EG001233 events89 affected287 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00010 events9 affected292 at risk EG00147 events27 affected287 at risk
Eructation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected292 at risk EG00126 events16 affected287 at risk
Flatulence	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0008 events8 affected292 at risk EG00124 events19 affected287 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0009 events7 affected292 at risk EG00144 events19 affected287 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG000112 events41 affected292 at risk EG001499 events114 affected287 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected292 at risk EG001133 events52 affected287 at risk
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	EG0009 events9 affected292 at risk EG00123 events20 affected287 at risk
Injection site reaction	General disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected292 at risk EG001204 events32 affected287 at risk
Covid-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00080 events74 affected292 at risk EG00169 events66 affected287 at risk
Influenza	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00030 events25 affected292 at risk EG00113 events12 affected287 at risk
Sinusitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00018 events16 affected292 at risk EG0016 events6 affected287 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00032 events21 affected292 at risk EG00137 events25 affected287 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00013 events12 affected292 at risk EG00133 events27 affected287 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00016 events15 affected292 at risk EG0018 events7 affected287 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00016 events15 affected292 at risk EG00119 events17 affected287 at risk
Dizziness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected292 at risk EG00124 events20 affected287 at risk
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00027 events22 affected292 at risk EG00137 events27 affected287 at risk
Anxiety	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG00019 events19 affected292 at risk EG0019 events9 affected287 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0006 events4 affected292 at risk EG00120 events20 affected287 at risk

ID	Term
D009765	Obesity
D050177	Overweight
D009043	Motor Activity
D009748	Nutrition Disorders

ID	Term
D044343	Overnutrition
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001519	Behavior

ID	Term
D000067757	Glucagon-Like Peptide-1 Receptor
D000067756	Glucagon-Like Peptide Receptors
D043562	Receptors, G-Protein-Coupled
D011956	Receptors, Cell Surface
D008565	Membrane Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D011964	Receptors, Gastrointestinal Hormone
D018000	Receptors, Peptide

ID	Title	Description
BG000	Placebo	Participants received matching placebo SC QW.
BG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received matching placebo SC once weekly QW.	1	292	14	292	172	292
EG001	Tirzepatide	Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.	1	287	17	287	230	287