A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program

Eli Lilly and Company579 enrolled

Overview

This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

579

Conditions

Obesity Overweight

Interventions

TirzepatideDRUG

Administered SC

PlaceboOTHER

Administered SC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease * History of at least one unsuccessful dietary effort to lose body weight Exclusion Criteria: * Diabetes mellitus * Change in body weight greater than 5 kg within 3 months prior to starting study * Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity * History of pancreatitis * Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) * History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years * Any lifetime history of a suicide attempt

Locations (65)

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: Week 72

Secondary Outcomes

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.

Time frame: 72 Weeks

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.

Time frame: 72 Weeks

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.

Time frame: 72 Weeks

Percentage of Participants Who Achieve ≥20% Body Weight Reduction

Data from ClinicalTrials.gov

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National Research Institute - Huntington Park

Huntington Park, California, United States

National Research Institute - Wilshire

Los Angeles, California, United States

Catalina Research Institute, LLC

Montclair, California, United States

National Research Institute (NRI) - Santa Ana

Santa Ana, California, United States

Encompass Clinical Research

Spring Valley, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Clinical Research of South Florida

Coral Gables, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Precision Clinical Research

Sunrise, Florida, United States

...and 55 more locations

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.

Time frame: 72 Weeks

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).

Time frame: Baseline, 72 Weeks

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).

Time frame: Baseline, 72 Weeks

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).

Time frame: Baseline, 72 Weeks

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).

Time frame: Baseline, 72 Weeks

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).

Time frame: Baseline, 72 Weeks

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).

Time frame: Baseline, 72 Weeks

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).

Time frame: Baseline, 72 Weeks

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).

Time frame: Baseline, 72 Weeks

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).

Time frame: Baseline, 72 Weeks

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).

Time frame: Baseline, 72 Weeks

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).

Time frame: Baseline, 72 Weeks

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).

Time frame: Baseline, 72 Weeks

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).

Time frame: Baseline, 72 Weeks

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).

Time frame: Baseline, 72 Weeks

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.

Time frame: Baseline, 72 Weeks

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.

Time frame: Baseline, 72 Weeks