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Active, Not Recruiting

NCT Number: NCT06662383

A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity

The main purpose of this study is to evaluate the efficacy and safety of retatrutide compared to tirzepatide in adults who have obesity. The study will last about 89 weeks.

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

DIM Clínica Privada, Ramos Mejía, Buenos Aires, Argentina

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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 taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
  • 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)
  • coronary revascularization
  • 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.

Treatment and study plan

Retatrutide

Drug

Administered SC

Other names: LY3437943

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Primary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 80

Secondary outcomes

  1. Change from Baseline in Body Mass Index (BMI)

    Time frame: Baseline, Week 80

  2. Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 80

  3. Percent Change from Baseline in Total Cholesterol

    Time frame: Baseline, Week 80

  4. Percent Change from Baseline in Triglycerides

    Time frame: Baseline, Week 80

  5. Change from Baseline in Systolic Blood Pressure (SBP)

    Time frame: Baseline, Week 80

  6. Change from Baseline in Diastolic Blood Pressure (DBP)

    Time frame: Baseline, Week 80

  7. Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 80

  8. Percent Change from Baseline in Fasting Insulin

    Time frame: Baseline, Week 80

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

    Time frame: Baseline, Week 80

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Retatrutide Compared to Tirzepatide in Adults Who Have Obesity

Acronym: TRIUMPH-5

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 28, 2024
Registry last updated
Jul 20, 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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