A Study of Retatrutide (LY3437943) in Participants Without Type 2 Diabetes Who Have Obesity or Overweight (TRIUMPH-9)

June 8, 2026 updated by: Eli Lilly and Company

A Phase 3b Study to Investigate the Efficacy and Safety of Different Retatrutide Dose Escalation Schemes in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Controlled, Double-Blind Trial

The purpose of this study is to investigate the efficacy and safety of different retatrutide dose escalation schemes in participants without type 2 diabetes who have obesity or overweight. Participation in the study will last about 113 weeks.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

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

  • Argentina
      • Buenos Aires, Argentina, C1120AAC
        • Centro Medico Viamonte
      • Buenos Aires, Argentina, C1023AAB
        • STAT Research S.A.
      • Buenos Aires, Argentina, C1056ABI
        • Centro de Investigaciones Metabólicas (CINME)
      • Buenos Aires, Argentina, 1424
        • Cicemo Srl
      • Buenos Aires, Argentina, C1014ACP
        • CARDIAMET Investigaciones Médicas
  • Canada
      • Brampton, Canada, L6T 0G1
        • Aggarwal and Associates Limited
      • Courtice, Canada, L1E 2J5
        • Med Trust Research
      • Hamilton, Canada, L8J 0B6
        • Winterberry Research Inc.
      • Joliette, Canada, J6E 6A9
        • Diex Recherche Inc. Division Joliette
      • London, Canada, N5W 6A2
        • Milestone Research Inc.
      • Québec, Canada, G1V 4T3
        • Diex Recherche Inc. Division Quebec
      • Sherbrooke, Canada, J1L 0H8
        • Diex Recherche Inc. Division Sherbrooke
      • Toronto, Canada, M9V 4B4
        • Dr. Anil K. Gupta Medicine Professional Corporation
      • Toronto, Canada, M3J 0K2
        • Canadian Phase Onward
      • Trois-Rivières, Canada, G8T 7A1
        • C.I.C. Mauricie inc.
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Arizona Research Center
    • California
      • Huntington Beach, California, United States, 92648
        • Care Access - Huntington Beach
      • Los Angeles, California, United States, 90015
        • Los Angeles Institute for Metabolic Research
    • Florida
      • Miami, Florida, United States, 33165
        • New Horizon Research Center
      • Weston, Florida, United States, 33331
        • Encore Medical Research - Weston
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Pacific Diabetes & Endocrine Center
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Monroe Biomedical Research - Louisville
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital Diabetes Program
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Great Lakes Research Group, Inc.
    • New York
      • Long Island City, New York, United States, 11106
        • NYC Research INC
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Care Access - Raleigh
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • New Phase Research And Development
    • Texas
      • Dallas, Texas, United States, 75251
        • Cedar Health Research
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Research, Dallas
      • Dallas, Texas, United States, 75235
        • Cedar Health Research - Texas Native Health
      • Fort Worth, Texas, United States, 76132
        • Cedar Health Research - Fort Worth
    • Utah
      • Ogden, Utah, United States, 84405
        • Advanced Research Institute
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Dominion Medical Associates, Inc.
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • CAMC Institute for Academic Medicine

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) at screening

    • ≥ 30 kilogram per square meter (kg/m2) OR
    • ≥ 27 kg/m2 with presence of at least one of the following weight-related conditions at screening: 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 kilograms (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:

    • heart attack
    • stroke
    • hospitalization for unstable angina or 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
Experimental: Retatrutide Dose Escalation 1
Participants will receive retatrutide subcutaneously (SC)
Drug: Retatrutide
Administered SC
Other Names:
  • LY3437943
Experimental: Retatrutide Dose Escalation 2
Participants will receive retatrutide SC
Drug: Retatrutide
Administered SC
Other Names:
  • LY3437943
Experimental: Retatrutide Dose Escalation 3
Participants will receive retatrutide SC
Drug: Retatrutide
Administered SC
Other Names:
  • LY3437943

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 104
Baseline, Week 104

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Waist Circumference
Time Frame: Baseline, Week 104
Baseline, Week 104
Percent Change from Baseline in Triglycerides
Time Frame: Baseline, Week 104
Baseline, Week 104
Change from Baseline in Systolic Blood Pressure
Time Frame: Baseline, Week 104
Baseline, Week 104
Percent Change from Baseline in High Sensitivity C-Reactive Protein
Time Frame: Baseline, Week 104
Baseline, Week 104
Change from Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials (IWQOL-Lite-CT) Total Score
Time Frame: Baseline, Week 104
Baseline, Week 104
Overall Treatment Satisfaction with Medication for Obesity (TS-MO) Scores
Time Frame: Week 104
Week 104
Pharmacokinetics (PK): Steady state Average Trough PK Concentration
Time Frame: Baseline through Week 104
Baseline through Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

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.

Helpful Links

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)

January 24, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27795
  • J1I-MC-GZQL (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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