A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program
SURMOUNT-3
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)
2 other identifiers
interventional
579
4 countries
65
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 obesity
Started Mar 2021
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2020
CompletedFirst Posted
Study publicly available on registry
December 7, 2020
CompletedStudy Start
First participant enrolled
March 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 12, 2023
CompletedResults Posted
Study results publicly available
May 16, 2024
CompletedMay 16, 2024
May 1, 2024
2.1 years
December 1, 2020
April 16, 2024
May 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 (20)
Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program
72 Weeks
Percentage of Participants Who Achieve ≥10%Body Weight Reduction
72 Weeks
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
72 Weeks
Percentage of Participants Who Achieve ≥20% Body Weight Reduction
72 Weeks
Change From Baseline in Waist Circumference
Baseline, 72 Weeks
- +15 more secondary outcomes
Study Arms (2)
Tirzepatide
EXPERIMENTALParticipants 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.
Placebo
PLACEBO COMPARATORParticipants received matching placebo SC once weekly (QW).
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
National Research Institute - Huntington Park
Huntington Park, California, 90255, United States
National Research Institute - Wilshire
Los Angeles, California, 90057, United States
Catalina Research Institute, LLC
Montclair, California, 91763, United States
National Research Institute (NRI) - Santa Ana
Santa Ana, California, 92704, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Precision Clinical Research
Sunrise, Florida, 33351, United States
Clinical Research of West Florida
Tampa, Florida, 33606, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401, United States
Elite Clinical Trials
Blackfoot, Idaho, 83221, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Elite Clinical Trials
Rexburg, Idaho, 83440, United States
Evanston Premier Healthcare Research LLC
Evanston, Illinois, 60201, United States
American Health Network of IN, LLC
Avon, Indiana, 46123, United States
American Health Network of IN, LLC
Franklin, Indiana, 46131, United States
American Health Network of IN, LLC
Muncie, Indiana, 47304, United States
Cotton O'Neil Mulvane
Topeka, Kansas, 66606, United States
Tandem Clinical Research,LLC
Marrero, Louisiana, 70072, United States
The National Diabetes & Obesity Research Institute
Biloxi, Mississippi, 39532, United States
Clinvest Research LLC
Springfield, Missouri, 65810, United States
Quality Clinical Research
Omaha, Nebraska, 68114, United States
Palm Research Center Sunset
Las Vegas, Nevada, 89148, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514, United States
PharmQuest
Greensboro, North Carolina, 27408, United States
Wake Forest University Baptist Medical Center (WFUBMC)
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44122, United States
Intend Research, LLC
Norman, Oklahoma, 73069, United States
Summit Research Network
Portland, Oregon, 97210, United States
Detweiler Family Medicine & Associates
Lansdale, Pennsylvania, 19446, United States
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
Pittsburgh, Pennsylvania, 15243, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607, United States
Holston Medical Group
Bristol, Tennessee, 37620, United States
Vanderbilt Health One Hundred Oaks
Nashville, Tennessee, 37204, United States
Dallas Diabetes Research Center
Dallas, Texas, 75230, United States
Juno Research
Houston, Texas, 77040, United States
Southern Endocrinology Associates
Mesquite, Texas, 75149, United States
Texas Diabetes & Endocrinology, P.A.
Round Rock, Texas, 78681, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98405, United States
Centro Médico Viamonte
CABA, Buenos Aires, C1120AAC, Argentina
Investigaciones Medicas Imoba Srl
CABA, Buenos Aires, C1179AAB, Argentina
Instituto Centenario
CABA, Buenos Aires, C1204AAD, Argentina
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aire, Buenos Aires, 1056, Argentina
Stat Research S.A.
Ciudad Autónoma de Buenos Aire, Buenos Aires, C1023AAB, Argentina
Glenny Corp
Buenos Aires, Ciudad Autónoma de Buenos Aire, 1430, Argentina
CEMEDIAB
C.a.b.a., Ciudad Autónoma de Buenos Aire, C1205AAO, Argentina
Instituto Médico Especializado (IME)
Buenos Aires, 1405, Argentina
Sanatorio Norte
Santiago del Estero, 4200, Argentina
CEDOES
Vitória, Espírito Santo, 29055450, Brazil
Cline Research Center
Curitiba, Paraná, 80030-480, Brazil
Quanta Diagnóstico e Terapia
Curitiba, Paraná, 80040-110, Brazil
CPCLIN
São Paulo, São Paulo, 01228-200, Brazil
BR Trials - Ensaios Clinicos e Consultoria
São Paulo, São Paulo, 03325-050, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, 22241-180, Brazil
CPQuali Pesquisa Clínica
São Paulo, 01228-000, Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010, Brazil
Advanced Clinical Research, LLC
Bayamón, 00961, Puerto Rico
Manati Center for Clinical Research
Manatí, 00674, Puerto Rico
Ponce Medical School Foundation Inc.
Ponce, 00716, Puerto Rico
Related Publications (5)
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.
PMID: 41640675DERIVEDWadden TA, Oquendo MA, Kushner RF, Cao D, Karanikas CA, Kechter A, Murphy MA. Psychiatric Safety of Tirzepatide in People With Obesity and No Known Major Psychopathology: A Post Hoc Analysis of SURMOUNT. Obesity (Silver Spring). 2026 Jan 15. doi: 10.1002/oby.70122. Online ahead of print.
PMID: 41537305DERIVEDLi X, Cao D, Sapin H, Wang F, Hunter Gibble T, Raibulet NK, Denning M, Kaplan LM. People With Lowest Physical Functioning Scores Showed Greatest Improvement After Tirzepatide Treatment. Obesity (Silver Spring). 2026 Jan;34(1):114-126. doi: 10.1002/oby.70067. Epub 2025 Nov 4.
PMID: 41187013DERIVEDGourgari E, Srivastava G, Kelly AS, Mojdami D, Cao D, Murphy MA, Karanikas CA, Lee CJ. Early-Onset Obesity and Tirzepatide Treatment: A Post Hoc Analysis of the SURMOUNT Clinical Trials. Obesity (Silver Spring). 2025 Sep;33(9):1668-1679. doi: 10.1002/oby.24348. Epub 2025 Jul 27.
PMID: 40717199DERIVEDWadden TA, Chao AM, Machineni S, Kushner R, Ard J, Srivastava G, Halpern B, Zhang S, Chen J, Bunck MC, Ahmad NN, Forrester T. Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Nat Med. 2023 Nov;29(11):2909-2918. doi: 10.1038/s41591-023-02597-w. Epub 2023 Oct 15.
PMID: 37840095DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2020
First Posted
December 7, 2020
Study Start
March 29, 2021
Primary Completion
April 20, 2023
Study Completion
May 12, 2023
Last Updated
May 16, 2024
Results First Posted
May 16, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.