- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07232719
A Study of Retatrutide (LY3437943) in Participants With Obesity or Overweight (TRIUMPH-8)
April 16, 2026 updated by: Eli Lilly and Company
A Phase 3b Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial
The purpose of this study is to evaluate the efficacy and safety of retatrutide compared with placebo for body weight reduction.
Participation in the study will last about 65 weeks and may include about 18 visits.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
250
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
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-
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Birmingham, United Kingdom, B21 9RY
- FutureMeds - Birmingham
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Blackpool, United Kingdom, FY3 7EN
- Layton Medical Centre
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Bradford-on-Avon, United Kingdom, BA15 1DQ
- Bradford on Avon Health Centre
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Bromborough, United Kingdom, CH62 6EE
- FutureMeds - Liverpool
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Cheadle, United Kingdom, ST10 1NS
- Cheadle Community Hospital
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Hounslow, United Kingdom, TW4 7NR
- HMC Health Group - Meadows Centre for Health
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Oxford, United Kingdom, OX4 1XB
- St Bartholomew's Medical Centre
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Penzance, United Kingdom, TR18 3DX
- Atlantic Medical
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Poole, United Kingdom, BH16 5PW
- The Adam Practice
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Rotherham, United Kingdom, S61 1AH
- Woodstock Bower Surgery
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Torpoint, United Kingdom, PL11 2TB
- Rame Group Practice
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Wellingborough, United Kingdom, NN8 4RW
- Albany House Medical Centre
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-
-
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California
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Riverside, California, United States, 92503
- Artemis Institute for Clinical Research
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Florida
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Atlantis, Florida, United States, 33462
- JEM Research Institute
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Orlando, Florida, United States, 32806
- Headlands Research Orlando
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Tamarac, Florida, United States, 33321
- Care Access - Tamarac
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Illinois
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Arlington Heights, Illinois, United States, 60005
- Care Access - Arlington Heights
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Kentucky
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Louisville, Kentucky, United States, 40213
- L-MARC Research Center
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Louisiana
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Monroe, Louisiana, United States, 71201
- IMA Clinical Research Monroe - Armand
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Maryland
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Baltimore, Maryland, United States, 21208
- Pharmasite Research, Inc.
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Missouri
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Chesterfield, Missouri, United States, 63005
- Clinical Research Professionals
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Springfield, Missouri, United States, 65807
- Clinvest Headlands Llc
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New Jersey
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Warren Township, New Jersey, United States, 07059
- IMA Clinical Research Warren
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New York
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New York, New York, United States, 10036
- Ima Clinical Research Manhattan
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North Carolina
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Wilmington, North Carolina, United States, 28403
- Trial Management Associates - Wilmington - Floral Parkway
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Texas
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Dallas, Texas, United States, 75251
- Cedar Health Research
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El Paso, Texas, United States, 79902
- Headlands Research-El Paso
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Euless, Texas, United States, 76040
- Cedar Health Research - Euless
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Fort Worth, Texas, United States, 76132
- Cedar Health Research - Fort Worth
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Houston, Texas, United States, 77054
- Care Access - Houston
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San Antonio, Texas, United States, 78229
- IMA Clinical Research San Antonio
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Have a body mass index (BMI) of:
- ≥30 kilogram per square meter (kg/m2) OR
- ≥27 kg/m2 with at least one of the following weight-related conditions: high blood pressure, abnormal levels of lipid, obstructive sleep apnea, heart disease
- Have at least one unsuccessful attempt to lose weight by dieting
Exclusion Criteria:
- Have a self-reported change in body weight >5 kg (11 pounds) within 90 days before screening
- Have a prior or planned surgical treatment for obesity
- Have type 1 diabetes or type 2 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
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 |
|---|---|
|
Placebo Comparator: Placebo
Participants will receive placebo SC
|
Administered SC
|
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Experimental: Retatrutide Dose 1
Participants will receive retatrutide subcutaneously (SC)
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Administered SC
Other Names:
|
|
Experimental: Retatrutide Dose 2
Participants will receive retatrutide SC
|
Administered SC
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 56
|
Baseline, Week 56
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from Baseline in Systolic Blood Pressure
Time Frame: Baseline, Week 56
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Baseline, Week 56
|
|
Change from Baseline in Waist Circumference
Time Frame: Baseline, Week 56
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Baseline, Week 56
|
|
Percent Change from Baseline in Non-High-Density Lipoprotein (HDL) Cholesterol
Time Frame: Baseline, Week 56
|
Baseline, Week 56
|
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Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)
Time Frame: Baseline through Week 56
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Baseline through Week 56
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
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.
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)
November 17, 2025
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Study Registration Dates
First Submitted
November 14, 2025
First Submitted That Met QC Criteria
November 14, 2025
First Posted (Actual)
November 18, 2025
Study Record Updates
Last Update Posted (Actual)
April 17, 2026
Last Update Submitted That Met QC Criteria
April 16, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27769
- J1I-MC-GZQJ (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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 or approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal should be approved by an independent review panel and researchers should 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
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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