A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Once Weekly 5 mg and/or Maximum Tolerated Dose Versus Placebo for Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (SURMOUNT-MAINTAIN)
2 other identifiers
interventional
441
1 country
20
Brief Summary
The main purpose of this study is to evaluate the efficacy and safety of tirzepatide for the maintenance of body weight reduction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2023
20 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
September 14, 2023
CompletedStudy Start
First participant enrolled
September 20, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2026
CompletedMarch 25, 2026
March 1, 2026
2.3 years
September 14, 2023
March 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Maintenance of Body Weight (BW) Reduction Achieved during the 60-Week Weight Loss Period
Mean percent maintenance of BW reduction achieved during the 60-Week weight loss period will be measured in participants who have reached a BW plateau.
Week 112
Secondary Outcomes (7)
Number of Participants with an Assessment of (yes/no) of Maintaining ≥80% of the BW Reduction Achieved During the 60-week Weight-Loss Period
Week 112
Number of Participants with an Assessment of (yes/no) of Maintaining ≥ 15% BW Reduction for Participants Who Have Already Lost ≥15% BW at Randomization
Week 112
Percent Change from Baseline in Body Weight
Baseline (Week 0), Week 112
Change from Randomization in Body Weight
Week 60, Week 112
Percent Change from Randomization in Body Weight
Week 60, Week 112
- +2 more secondary outcomes
Study Arms (3)
Tirzepatide 5 milligram (mg)
EXPERIMENTALParticipants will receive tirzepatide subcutaneously (SC).
Tirzepatide Maximum Tolerated Dose
EXPERIMENTALParticipants will receive tirzepatide SC.
Placebo
PLACEBO COMPARATORParticipants will receive placebo.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- Have a Body Mass Index (BMI) of ≥30 kilogram/square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least 1 of the following weight related comorbidities:
- Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
- Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight (BW)
You may not qualify if:
- Have Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D), a history of ketoacidosis, or hyperosmolar state or coma.
- Have a self-reported change in BW\>5 kilogram (kg) within 3 months prior to screening
- Have a prior or planned surgical treatment for obesity, excluding liposuction or abdominoplasty if performed \>1 year prior to screening.
- Have a history of chronic or acute pancreatitis
- Have any of the following cardiovascular conditions within 3 months prior to week 0.
- Acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, and hospitalization due to congestive heart failure (CHF)
- 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 (20)
Cahaba Research - Pelham
Pelham, Alabama, 35124, United States
Velocity Clinical Research, Westlake
Los Angeles, California, 90057, United States
Southern California Dermatology, Inc.
Santa Ana, California, 92701, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Oviedo Medical Research
Oviedo, Florida, 32765, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
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
Asha Clinical Research - Munster
Hammond, Indiana, 46324, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Prime Health and Wellness/SKYCRNG
Fayette, Mississippi, 39069, United States
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, 73069, United States
WR-Clinsearch, LLC
Chattanooga, Tennessee, 37397, United States
The University of Texas Health Science Center at Houston
Bellaire, Texas, 77401, United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230, United States
Southern Endocrinology Associates
Mesquite, Texas, 75149, United States
Pinnacle Clinical Research
San Antonio, Texas, 78229, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Related Publications (1)
Horn DB, Aronne LJ, Wharton S, Bays HE, Gomez-Valderas E, Arad AD, Sharma P, Dunn JP, Senyucel C, Lee CJ. Tirzepatide for the Maintenance of Body Weight Reduction: Rationale, Design, and Baseline Characteristics of SURMOUNT-MAINTAIN. Obesity (Silver Spring). 2025 Oct;33(10):1873-1885. doi: 10.1002/oby.70014. Epub 2025 Sep 7.
PMID: 40916045DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
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
September 14, 2023
First Posted
September 21, 2023
Study Start
September 20, 2023
Primary Completion
January 20, 2026
Study Completion
January 20, 2026
Last Updated
March 25, 2026
Record last verified: 2026-03
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 participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.