A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals With Obesity
TRIUMPH-6
A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Retatrutide Treatment in the Maintenance of Weight Reduction in Individuals With Obesity
2 other identifiers
interventional
643
3 countries
53
Brief Summary
This is a study of retatrutide in participants with obesity. The main purpose is to learn more about how retatrutide maintains body weight loss. The study will have two treatment phases: an 80 week lead-in phase in which all participants will take retatrutide dose 1 and a 36 week randomized, double-blinded phase in which participants will either take retatrutide dose 1, retatrutide dose 2, or switch to placebo. Participation in the study will last around 125 weeks.
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 2025
Typical duration for phase_3 obesity
53 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
February 28, 2025
CompletedFirst Posted
Study publicly available on registry
March 5, 2025
CompletedStudy Start
First participant enrolled
March 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
March 3, 2026
February 1, 2026
3.1 years
February 28, 2025
February 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change from Baseline in Body Weight
Week 0, Week 116
Secondary Outcomes (3)
Change from Baseline in Waist Circumference
Week 0, Week 116
Percentage of Body Weight Reduction Achieved at Week 80 that is Maintained at Week 116
Week 0, Week 80, Week 116
Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)
Week 0, Week 116
Study Arms (3)
Retatrutide Dose 1
EXPERIMENTALParticipants will receive retatrutide dose 1 administered subcutaneously (SC) for 116 weeks
Retatrutide Dose 1 to Retatrutide Dose 2
EXPERIMENTALParticipants will receive retatrutide dose 1 administered SC for 80 weeks, then retatrutide dose 2 administered SC for an additional 36 weeks
Retatrutide Dose 1 to Placebo
PLACEBO COMPARATORParticipants will receive retatrutide dose 1 administered SC for 80 weeks, then placebo administered SC for an additional 36 weeks
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight
You may not qualify if:
- Have a self-reported change in body weight \>5 kilograms (kg) (11 pounds) within 90 days before screening
- Have a prior or planned surgical treatment for obesity
- Have a prior or planned endoscopic procedure and/or device-based therapy for obesity
- Have Type 1 Diabetes, Type 2 Diabetes, or any other type of diabetes
- Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- Have had within the past 90 days before screening:
- acute myocardial infarction
- cerebrovascular accident (stroke)
- hospitalization for unstable angina, or
- hospitalization due to congestive heart failure
- Have New York Heart Association Functional Classification Class IV congestive heart failure
- Have a history of chronic or acute pancreatitis
- Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Southern California Clinical Research
Santa Ana, California, 92701, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
CMR of Greater New Haven, LLC
Hamden, Connecticut, 06517, United States
ALL Medical Research, LLC
Cooper City, Florida, 33024, United States
Florida International Medical Research
Coral Gables, Florida, 33134, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Charter Research - Winter Park
Orlando, Florida, 32803, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401, United States
Kubost Clinical Research - Marietta
Marietta, Georgia, 30062, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, 96817, United States
Alliance for Multispecialty Research, LLC
Oak Brook, Illinois, 60523, United States
Springfield Clinic Main Campus
Springfield, Illinois, 62703, United States
Alliance for Multispecialty Research, LLC
Lexington, Kentucky, 40509, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
Care Access - Lake Charles (Bayou Pines)
Lake Charles, Louisiana, 70601, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Alliance for Multispecialty Research, LLC
Kansas City, Missouri, 64114, United States
Vector Clinical Trials
Las Vegas, Nevada, 89128, United States
Dent Neurosciences Research Center, Inc
Amherst, New York, 14226, United States
Carteret Medical Group
Morehead City, North Carolina, 28557, United States
Care Access - Raleigh
Raleigh, North Carolina, 27607, United States
Tekton Research, LLC.
Moore, Oklahoma, 73160, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
Care Access - Rapid City
Rapid City, South Dakota, 57701, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37909, United States
Care Access - Houston
Houston, Texas, 77054, United States
Southern Endocrinology Associates
Mesquite, Texas, 75149, United States
Sleep Therapy Research Center
San Antonio, Texas, 78229, United States
National Clinical Research, Inc
Richmond, Virginia, 23294, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington, 98801, United States
Aggarwal and Associates Limited
Brampton, L6T 0G1, Canada
Circulate Cardiac & Vascular Centre
Burlington, L7M 1K9, Canada
Med Trust Research
Courtice, L1E 2J5, Canada
Winterberry Research Inc.
Hamilton, L8J 0B6, Canada
Centre de Medecine Metabolique de Lanaudiere (CMML)
Terrebonne, J6X 4P7, Canada
Care Access - Thunder Bay - Barton Street
Thunder Bay, P7B 7C7, Canada
Maple Leaf Research
Toronto, M5G 1K2, Canada
C.I.C. Mauricie inc.
Trois-Rivières, G8T 7A1, Canada
FutureMeds - Birmingham
Birmingham, B21 9RY, United Kingdom
Oakenhurst Medical Practice
Blackburn, BB2 1AX, United Kingdom
Layton Medical Centre
Blackpool, FY3 7EN, United Kingdom
Bradford on Avon Health Centre
Bradford-on-Avon, BA15 1DQ, United Kingdom
FutureMeds - Liverpool
Bromborough, CH62 6EE, United Kingdom
Cheadle Community Hospital
Cheadle, ST10 1NS, United Kingdom
HMC Health Group - Meadows Centre for Health
Hounslow, TW4 7NR, United Kingdom
St Bartholomew's Medical Centre
Oxford, OX4 1XB, United Kingdom
Atlantic Medical
Penzance, TR18 3DX, United Kingdom
The Adam Practice
Poole, BH16 5PW, United Kingdom
Woodstock Bower Surgery
Rotherham, S61 1AH, United Kingdom
Rame Group Practice
Torpoint, PL11 2TB, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 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
February 28, 2025
First Posted
March 5, 2025
Study Start
March 5, 2025
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
March 3, 2026
Record last verified: 2026-02
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 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.