Phase 3Active, not recruiting
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
- Sponsor
- Eli Lilly and Company (Industry)
- Enrolment
- 10,000 planned
- Conditions
- Atherosclerotic Cardiovascular Disease (ASCVD); Chronic Kidney Disease (CKD)
- Interventions
- Retatrutide; Placebo
- Ages
- adults, older adults
- Registry
- NCT06383390, CTIS2023-508630-34-00
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Time to First Occurrence of Composite Endpoints
- Time to First Occurrence of Composite Endpoint of End Stage Kidney Disease (ESKD), ≥ 40% Sustained Decline in Estimated Glomerular Filtration Rate (eGFR), CV Death or Renal Death
History
Primary completion expected
Last registry update
Started
Registered