Recruiting
PHASE3
INTERVENTIONAL
NCT06383390
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
Retatrutide
Type:
DRUG
Description:
Administered SC
Name:
Placebo
Type:
DRUG
Description:
Administered SC
Primary Outcomes
Measure:
Time to First Occurrence of Composite Endpoints
TimeFrame:
Randomization up to Study Completion (Approximate 248 Weeks)
Description:
A composite endpoint includes nonfatal myocardial infarction (MI), nonfatal stroke, cardiovascular (CV) death, or hospitalization or urgent visit due to heart failure (HF).
Measure:
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
TimeFrame:
Randomization up to Study Completion (Approximate 248 Weeks)
Description:
ESKD is defined as the following individual components: persistent eGFR \<15 mL/min/1.73 m\^2 confirmed by 2 measurements at least 4 weeks apart at the central laboratory, initiation of dialysis for at least 28 days, receiving a kidney transplant.
Sustained decline in eGFR (≥40%) will be confirmed by a repeated measure at least 4 weeks after the first result.
Trial Information
NCT ID
NCT06383390
Status
Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Eli Lilly and Company
Last Updated
December 15, 2025