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

May 8, 2024 updated by: Eli Lilly and Company

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

579

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1405
        • Instituto Médico Especializado (IME)
      • Santiago del Estero, Argentina, 4200
        • Sanatorio Norte
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1120AAC
        • Centro Medico Viamonte
      • Caba, Buenos Aires, Argentina, C1179AAB
        • Investigaciones Medicas IMOBA SRL
      • Caba, Buenos Aires, Argentina, C1204AAD
        • Instituto Centenario
      • Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina, 1056
        • Centro de Investigaciones Metabólicas (CINME)
      • Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina, C1023AAB
        • STAT Research S.A.
    • Ciudad Autónoma De Buenos Aire
      • Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina, 1430
        • Glenny Corp
      • C.a.b.a., Ciudad Autónoma De Buenos Aire, Argentina, C1205AAO
        • CEMEDIAB
  • Brazil
      • Rio de Janeiro, Brazil, 22241-180
        • IBPClin - Instituto Brasil de Pesquisa Clínica
      • São Paulo, Brazil, 01228-000
        • CPQuali Pesquisa Clínica
      • São Paulo, Brazil, 04266-010
        • CEPIC - Centro Paulista de Investigacao Clinica
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29055450
        • CEDOES
    • Paraná
      • Curitiba, Paraná, Brazil, 80030-480
        • Cline Research Center
      • Curitiba, Paraná, Brazil, 80040-110
        • Quanta Diagnóstico e Terapia
    • São Paulo
      • Sao Paulo, São Paulo, Brazil, 01228-200
        • CPCLIN
      • Sao Paulo, São Paulo, Brazil, 03325-050
        • BR Trials - Ensaios Clinicos e Consultoria
  • Puerto Rico
      • Bayamon, Puerto Rico, 00961
        • Advanced Clinical Research, LLC
      • Manati, Puerto Rico, 00674
        • Manati Center for Clinical Research
      • Ponce, Puerto Rico, 00716
        • Ponce Medical School Foundation Inc.
  • United States
    • California
      • Huntington Park, California, United States, 90255
        • National Research Institute - Huntington Park
      • Los Angeles, California, United States, 90057
        • National Research Institute - Wilshire
      • Montclair, California, United States, 91763
        • Catalina Research Institute, LLC
      • Santa Ana, California, United States, 92704
        • National Research Institute (NRI) - Santa Ana
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of South Florida
      • Miami, Florida, United States, 33165
        • New Horizon Research Center
      • Sunrise, Florida, United States, 33351
        • Precision Clinical Research
      • Tampa, Florida, United States, 33606
        • Clinical Research of West Florida
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Institute, Inc.
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Elite Clinical Trials
      • Meridian, Idaho, United States, 83646
        • Solaris Clinical Research
      • Rexburg, Idaho, United States, 83440
        • Elite Clinical Trials
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Evanston Premier Healthcare Research LLC
    • Indiana
      • Avon, Indiana, United States, 46123
        • American Health Network of IN, LLC
      • Franklin, Indiana, United States, 46131
        • American Health Network of IN, LLC
      • Muncie, Indiana, United States, 47304
        • American Health Network of IN, LLC
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Mulvane
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Tandem Clinical Research,LLC
    • Mississippi
      • Biloxi, Mississippi, United States, 39532
        • The National Diabetes & Obesity Research Institute
    • Missouri
      • Springfield, Missouri, United States, 65810
        • Clinvest Research LLC
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Quality Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center Sunset
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, Inc.
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina Medical Center
      • Greensboro, North Carolina, United States, 27408
        • PharmQuest
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center (WFUBMC)
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Cleveland Clinic Foundation
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Intend Research, LLC
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network
    • Pennsylvania
      • Lansdale, Pennsylvania, United States, 19446
        • Detweiler Family Medicine & Associates
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Medicine: University of Pennsylvania Health System
      • Pittsburgh, Pennsylvania, United States, 15243
        • Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Tribe Clinical Research, LLC
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Holston Medical Group
      • Nashville, Tennessee, United States, 37204
        • Vanderbilt Health One Hundred Oaks
    • Texas
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes Research Center
      • Houston, Texas, United States, 77040
        • Juno Research
      • Mesquite, Texas, United States, 75149
        • Southern Endocrinology Associates
      • Round Rock, Texas, United States, 78681
        • Texas Diabetes & Endocrinology, P.A.
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research, LLC
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Health Research of Hampton Roads, Inc.
    • Washington
      • Tacoma, Washington, United States, 98405
        • MultiCare Institute for Research & Innovation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tirzepatide
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
Administered SC
Other Names:
  • LY3298176
Placebo Comparator: Placebo
Participants received matching placebo SC once weekly (QW).
Other: Placebo
Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Body Weight
Time Frame: Baseline, 72 Weeks
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
Time Frame: Week 72
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program
Time Frame: 72 Weeks
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
Percentage of Participants Who Achieve ≥10%Body Weight Reduction
Time Frame: 72 Weeks
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
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Time Frame: 72 Weeks
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
Percentage of Participants Who Achieve ≥20% Body Weight Reduction
Time Frame: 72 Weeks
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
Change From Baseline in Waist Circumference
Time Frame: Baseline, 72 Weeks
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
Change From Baseline in Body Weight
Time Frame: Baseline, 72 Weeks
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
Change From Baseline in Body Mass Index (BMI)
Time Frame: Baseline, 72 Weeks
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
Change From Baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline, 72 Weeks
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
Change From Baseline in Diastolic Blood Pressure (DBP)
Time Frame: Baseline, 72 Weeks
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
Percent Change From Baseline in Total Cholesterol
Time Frame: Baseline, 72 Weeks
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
Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol
Time Frame: Baseline, 72 Weeks
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
Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol
Time Frame: Baseline, 72 Weeks
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
Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol
Time Frame: Baseline, 72 Weeks
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
Percent Change From Baseline in Triglycerides
Time Frame: Baseline, 72 Weeks
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
Percent Change From Baseline in Free Fatty Acids
Time Frame: Baseline, 72 Weeks
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
Change From Baseline in Fasting Glucose
Time Frame: Baseline, 72 Weeks
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
Change From Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, 72 Weeks
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
Percent Change From Baseline in Fasting Insulin
Time Frame: Baseline, 72 Weeks
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
Change From Baseline in Short Form 36 Version 2 Health Survey Version 2 (SF 36v2) Acute Form Physical Functioning Domain Score
Time Frame: Baseline, 72 Weeks

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
Change From Baseline in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
Time Frame: Baseline, 72 Weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2021

Primary Completion (Actual)

April 20, 2023

Study Completion (Actual)

May 12, 2023

Study Registration Dates

First Submitted

December 1, 2020

First Submitted That Met QC Criteria

December 1, 2020

First Posted (Actual)

December 7, 2020

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17246
  • I8F-MC-GPHM (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Plan Description:

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

Access Criteria:

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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