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Trial · Interventional

Active, not recruitingPhase 3Registry data

A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals With Obesity

Short name TRIUMPH-6

NCTNCT06859268 (opens ClinicalTrials.gov in a new tab)Other id27268Other idJ1I-MC-GZQB
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 3
Enrollment
643 participants (estimated)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
3 countries

United States, Canada, United Kingdom

Start
5 Mar 2025
Primary completion
Apr 2028 (estimated)
Completion
Apr 2028 (estimated)
First posted
5 Mar 2025
Last update posted
3 Mar 2026
Conditions
Obesity

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026202720282029
  1. Ph 3

    TRIUMPH-6

    NCT06859268

    5 Mar 2025 to est. Apr 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • RetatrutideDrug
  • PlaceboDrug

Arms3

  • Experimental

    Retatrutide Dose 1

    Participants will receive retatrutide dose 1 administered subcutaneously (SC) for 116 weeks

  • Experimental

    Retatrutide Dose 1 to Retatrutide Dose 2

    Participants will receive retatrutide dose 1 administered SC for 80 weeks, then retatrutide dose 2 administered SC for an additional 36 weeks

  • Placebo comparator

    Retatrutide Dose 1 to Placebo

    Participants will receive retatrutide dose 1 administered SC for 80 weeks, then placebo administered SC for an additional 36 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Change from Baseline in Body Weight

    Time frame · Week 0, Week 116

Secondary outcomes(3)

  1. Change from Baseline in Waist Circumference

    Time frame · Week 0, Week 116

  2. Percentage of Body Weight Reduction Achieved at Week 80 that is Maintained at Week 116

    Time frame · Week 0, Week 80, Week 116

  3. Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)

    Time frame · Week 0, Week 116

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight 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 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

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