NCT06383390

The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and Major Adverse Kidney Events in Participants With Body Mass Index ≥27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10,000 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m\^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. The study will last for about 5 years. Participants will have up to 27 clinic visits with the study doctor.

Conditions

• Atherosclerotic Cardiovascular Disease (ASCVD)
• Chronic Kidney Disease (CKD)

Interventions

Type	Name	Description
DRUG	Retatrutide	Administered SC
DRUG	Placebo	Administered SC

Timeline

• Start date: 2024-04-30
• Primary completion: 2029-02-01
• Completion: 2029-02-01
• First posted: 2024-04-25
• Last updated: 2026-03-24

Locations

745 sites across 27 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Puerto Rico, Romania, Slovakia, Spain, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study