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NCT Number: NCT06859268

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aggarwal and Associates Limited, Brampton, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retatrutide

Drug

Administered SC

Other names: LY3437943

Placebo

Drug

Administered SC

Primary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: Week 0, Week 116

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Retatrutide Treatment in the Maintenance of Weight Reduction in Individuals With Obesity

Acronym: TRIUMPH-6

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 5, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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