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

Obesity Clinical Trial

— SURMOUNT-3  

Official title:

Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo After an Intensive Lifestyle Program in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double Blind, Placebo-Controlled Trial (SURMOUNT-3)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04657016
• Other study ID #: 17246
• Secondary ID: I8F-MC-GPHM
• Status: Completed
• Phase: Phase 3
• Start date: March 29, 2021
• Est. completion date: May 12, 2023

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 579
• Est. completion date: May 12, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• Tirzepatide
Administered SC

Other:
• Placebo
Administered SC

Locations

Country	Name	City	State
Argentina	Glenny Corp	Buenos Aires	Ciudad Autónoma De Buenos Aire
Argentina	Instituto Médico Especializado (IME)	Buenos Aires
Argentina	CEMEDIAB	C.a.b.a.	Ciudad Autónoma De Buenos Aire
Argentina	Centro Médico Viamonte	Caba	Buenos Aires
Argentina	Instituto Centenario	Caba	Buenos Aires
Argentina	Investigaciones Medicas Imoba Srl	Caba	Buenos Aires
Argentina	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autónoma de Buenos Aire	Buenos Aires
Argentina	Stat Research S.A.	Ciudad Autónoma de Buenos Aire	Buenos Aires
Argentina	Sanatorio Norte	Santiago del Estero
Brazil	Cline Research Center	Curitiba	Paraná
Brazil	Quanta Diagnóstico e Terapia	Curitiba	Paraná
Brazil	IBPClin - Instituto Brasil de Pesquisa Clínica	Rio de Janeiro
Brazil	BR Trials - Ensaios Clinicos e Consultoria	Sao Paulo	São Paulo
Brazil	CPCLIN	Sao Paulo	São Paulo
Brazil	CEPIC - Centro Paulista de Investigação Clínica	São Paulo
Brazil	CPQuali Pesquisa Clínica	São Paulo
Brazil	CEDOES	Vitória	Espírito Santo
Puerto Rico	Advanced Clinical Research, LLC	Bayamon
Puerto Rico	Manati Center for Clinical Research	Manati
Puerto Rico	Ponce Medical School Foundation Inc.	Ponce
United States	American Health Network of IN, LLC	Avon	Indiana
United States	The National Diabetes & Obesity Research Institute	Biloxi	Mississippi
United States	Elite Clinical Trials	Blackfoot	Idaho
United States	Holston Medical Group	Bristol	Tennessee
United States	University of North Carolina Medical Center	Chapel Hill	North Carolina
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	Evanston Premier Healthcare Research LLC	Evanston	Illinois
United States	American Health Network of IN, LLC	Franklin	Indiana
United States	PharmQuest	Greensboro	North Carolina
United States	Tribe Clinical Research, LLC	Greenville	South Carolina
United States	Juno Research	Houston	Texas
United States	National Research Institute - Huntington Park	Huntington Park	California
United States	Detweiler Family Medicine & Associates	Lansdale	Pennsylvania
United States	Palm Research Center Sunset	Las Vegas	Nevada
United States	National Research Institute - Wilshire	Los Angeles	California
United States	Tandem Clinical Research,LLC	Marrero	Louisiana
United States	Solaris Clinical Research	Meridian	Idaho
United States	Southern Endocrinology Associates	Mesquite	Texas
United States	New Horizon Research Center	Miami	Florida
United States	Catalina Research Institute, LLC	Montclair	California
United States	American Health Network of IN, LLC	Muncie	Indiana
United States	Vanderbilt Health One Hundred Oaks	Nashville	Tennessee
United States	Health Research of Hampton Roads, Inc.	Newport News	Virginia
United States	Intend Research, LLC	Norman	Oklahoma
United States	Quality Clinical Research	Omaha	Nebraska
United States	Penn Medicine: University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair	Pittsburgh	Pennsylvania
United States	Summit Research Network	Portland	Oregon
United States	Elite Clinical Trials	Rexburg	Idaho
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	Texas Diabetes & Endocrinology, P.A.	Round Rock	Texas
United States	National Research Institute (NRI) - Santa Ana	Santa Ana	California
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Encompass Clinical Research	Spring Valley	California
United States	Clinvest Research LLC	Springfield	Missouri
United States	Precision Clinical Research	Sunrise	Florida
United States	MultiCare Institute for Research & Innovation	Tacoma	Washington
United States	Clinical Research of West Florida	Tampa	Florida
United States	Cotton O'Neil Mulvane	Topeka	Kansas
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Metabolic Research Institute, Inc.	West Palm Beach	Florida
United States	Wake Forest University Baptist Medical Center (WFUBMC)	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Baseline, 72 Weeks
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.	Week 72
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.	72 Weeks
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.	72 Weeks
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.	72 Weeks
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.	72 Weeks
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).	Baseline, 72 Weeks
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).	Baseline, 72 Weeks
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).	Baseline, 72 Weeks
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).	Baseline, 72 Weeks
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).	Baseline, 72 Weeks
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).	Baseline, 72 Weeks
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).	Baseline, 72 Weeks
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).	Baseline, 72 Weeks
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).	Baseline, 72 Weeks
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).	Baseline, 72 Weeks
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).	Baseline, 72 Weeks
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).	Baseline, 72 Weeks
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).	Baseline, 72 Weeks
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).	Baseline, 72 Weeks
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.	Baseline, 72 Weeks
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.	Baseline, 72 Weeks

External Links

•   A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program (SURMOUNT-3)