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Active, Not Recruiting

NCT Number: NCT07232719

A Study of Retatrutide (LY3437943) in Participants With Obesity or Overweight

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.

Active, Not Recruiting

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

FutureMeds - Birmingham, Birmingham, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

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: Baseline, Week 56

Secondary outcomes

  1. Change from Baseline in Systolic Blood Pressure

    Time frame: Baseline, Week 56

  2. Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 56

  3. Percent Change from Baseline in Non-High-Density Lipoprotein (HDL) Cholesterol

    Time frame: Baseline, Week 56

  4. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)

    Time frame: Baseline through Week 56

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Acronym: TRIUMPH-8

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 18, 2025
Registry last updated
Apr 17, 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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