A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss
SURMOUNT-4
Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for Maintenance of Weight Loss in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-4)
2 other identifiers
interventional
783
5 countries
70
Brief Summary
This was a study of tirzepatide in participants with obesity or overweight. The main purpose was to learn more about how tirzepatide maintained body weight loss. The study had two phases: a lead-in phase in which all participants took tirzepatide and a treatment phase in which participants either continued tirzepatide or switched to placebo. The study lasted about 2 years (25 visits).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 obesity
Started Mar 2021
70 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 9, 2020
CompletedStudy Start
First participant enrolled
March 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2023
CompletedResults Posted
Study results publicly available
May 22, 2024
CompletedMay 22, 2024
May 1, 2024
2.1 years
December 1, 2020
April 25, 2024
May 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Randomization in Body Weight at Week 88
Least square (LS) mean was analysed by mixed model repeated measures (MMRM) model with randomization + analysis country + sex + interactive web response system (IWRS) MTD at Week 36 + treatment + time + treatment\*time (Type III sum of squares) as variables.
Randomization (Week 36), Week 88
Secondary Outcomes (25)
Percent Change From Randomization in Body Weight at Week 64
Randomization (Week 36), Week 64
Change From Randomization in Body Weight
Randomization (Week 36), Week 88
Change From Randomization in Waist Circumference
Randomization (Week 36), Week 88
Change From Randomization in Body Mass Index (BMI)
Randomization (Week 36), Week 88
Change From Randomization in Fasting Glucose
Randomization (Week 36), Week 88
- +20 more secondary outcomes
Study Arms (3)
Tirzepatide (lead-in)
EXPERIMENTALParticipants received weekly doses of tirzepatide subcutaneously (SC) for 36 weeks, starting at 2.5 milligrams (mg) and increasing by 2.5 mg every 4 weeks, as tolerated, up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg.
Tirzepatide MTD
EXPERIMENTALParticipants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks.
Placebo
PLACEBO COMPARATORParticipants received weekly doses of placebo SC for 52 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Body Mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, 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 (70)
Cahaba Research
Pelham, Alabama, 35124, United States
Scripps Memorial Hospital La Jolla
La Jolla, California, 92037, United States
National Research Institute - Wilshire
Los Angeles, California, 90057, United States
National Research Institute
Panorama City, California, 91402, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
University Clinical Investigators, Inc.
Tustin, California, 92780, United States
New West Physicians Clinical Research
Golden, Colorado, 80401, United States
Optumcare Colorado Springs - Monument
Monument, Colorado, 80132, United States
Care Partners Clinical Research
Jacksonville, Florida, 32277, United States
South Florida Clinical Research Institute
Margate, Florida, 33063, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076, United States
SKY Clinical Research Network Group-Blake
Union City, Georgia, 30291, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404, United States
Healthcare Research Network - Chicago
Flossmoor, Illinois, 60422, United States
Clinical Investigation Specialists
Gurnee, Illinois, 60031, United States
Midwest Institute For Clinical Research
Indianapolis, Indiana, 46260, United States
American Health Network of Indiana, LLC - New Albany
New Albany, Indiana, 47150, United States
Cotton O'Neil Clinic
Topeka, Kansas, 66606, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Centennial Medical Group
Elkridge, Maryland, 21075, United States
MedStar Health Research Institute (MedStar Physician Based Research Network)
Hyattsville, Maryland, 20782, United States
ActivMed Practices and Research
Methuen, Massachusetts, 01844, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Glacier View Research Institute - Endocrinology
Kalispell, Montana, 59901, United States
Weill Cornell Medical College
New York, New York, 10065, 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
Lillestol Research
Fargo, North Dakota, 58104, United States
Aventiv Research Inc
Columbus, Ohio, 43213, United States
Intend Research, LLC
Norman, Oklahoma, 73069, United States
Summit Research Network
Portland, Oregon, 97210, United States
Capital Area Research, LLC
Camp Hill, Pennsylvania, 17011, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607, United States
The University of Texas Health Science Center at Houston
Bellaire, Texas, 77401, United States
Dallas Diabetes Research Center
Dallas, Texas, 75230, United States
North Texas Endocrine Center
Dallas, Texas, 75231, United States
Biopharma Informatic, LLC
Houston, Texas, 77043, United States
North Hills Family Medicine/North Hills Medical Research
North Richland Hills, Texas, 76180, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Northwest Houston Heart Center
Tomball, Texas, 77375, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606, United States
Capital Clinical Research Center
Olympia, Washington, 98502, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
CEDIC
CABA, Buenos Aires, C1060ABN, Argentina
Centro Médico Viamonte
CABA, Buenos Aires, C1120AAC, Argentina
Stat Research S.A.
Ciudad Autónoma de Buenos Aire, Buenos Aires, C1023AAB, Argentina
Mautalen Salud e Investigación
Buenos Aires, Ciudad Autónoma de Buenos Aire, C1128AAF, Argentina
Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada
Ciudad Autonoma de Buenos Aire, Ciudad Autónoma de Buenos Aire, C1425AGC, Argentina
Instituto Médico Catamarca IMEC
Rosario, Santa Fe Province, 2000, Argentina
Asociación de Beneficencia Hospital Sirio Libanés
Buenos Aires, C1419AHN, Argentina
CEDOES
Vitória, Espírito Santo, 29055450, Brazil
Cline Research Center
Curitiba, Paraná, 80030-480, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90430-001, Brazil
Centro de Pesquisa Sao Lucas
Campinas, São Paulo, 13034-685, Brazil
ISPEM - Instituto São José dos Campos em Pesquisas Médicas
São José dos Campos, São Paulo, 12243-280, 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
Centro de Endocrinologia Alcantara Gonzalez
Bayamón, 00959, Puerto Rico
Private Practice Dr. Martha Gomez Cuellar
San Juan, 00921, Puerto Rico
Wellness clinical Research Vega Baja
Vega Baja, 00694, Puerto Rico
Chung Shan Medical University Hospital
Taichung, 402, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Cheng-Kung Uni. Hosp.
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Related Publications (7)
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: 41640675DERIVEDHorn DB, Linetzky B, Davies MJ, Laffin LJ, Wang H, Murphy MA, Zimner-Rapuch S, Lau E, Arad AD, Lee CJ. Cardiometabolic Parameter Change by Weight Regain on Tirzepatide Withdrawal in Adults With Obesity: A Post Hoc Analysis of the SURMOUNT-4 Trial. JAMA Intern Med. 2025 Nov 24:e256112. doi: 10.1001/jamainternmed.2025.6112. Online ahead of print.
PMID: 41284285DERIVEDLi 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: 41187013DERIVEDGibble TH, Cao D, Murphy M, Jouravskaya I, Liao B, Bays HE. Tirzepatide Associated With Improved Health-Related Quality of Life in Adults With Obesity or Overweight in SURMOUNT-4. Obesity (Silver Spring). 2025 Nov;33(11):2076-2092. doi: 10.1002/oby.70011. Epub 2025 Sep 3.
PMID: 40903801DERIVEDGourgari 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: 40717199DERIVEDHorn DB, Kahan S, Batterham RL, Cao D, Lee CJ, Murphy M, Gonsahn-Bollie S, Chigutsa F, Stefanski A, Dunn JP. Time to weight plateau with tirzepatide treatment in the SURMOUNT-1 and SURMOUNT-4 clinical trials. Clin Obes. 2025 Jun;15(3):e12734. doi: 10.1111/cob.12734. Epub 2025 Jan 12.
PMID: 39800653DERIVEDAronne LJ, Sattar N, Horn DB, Bays HE, Wharton S, Lin WY, Ahmad NN, Zhang S, Liao R, Bunck MC, Jouravskaya I, Murphy MA; SURMOUNT-4 Investigators. Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial. JAMA. 2024 Jan 2;331(1):38-48. doi: 10.1001/jama.2023.24945.
PMID: 38078870DERIVED
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 9, 2020
Study Start
March 29, 2021
Primary Completion
April 25, 2023
Study Completion
May 18, 2023
Last Updated
May 22, 2024
Results First Posted
May 22, 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
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.