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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

45 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Retatrutide — DRUG
  Administered SC
• Placebo — DRUG
  Administered SC

Study Details

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.

Key Dates

Start date

Apr 30, 2024

Status verified

Jun 2026

Primary completion

Feb 28, 2029

Completion

Feb 28, 2029

Study Design

Enrollment

10,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Retatrutide
  Participants will receive escalated doses of retatrutide administered subcutaneously (SC) up to a maximum tolerated dose.
• Placebo Comparator: Placebo
  Participants will receive matching placebo administered SC.

Primary Outcome Measure

Time to First Occurrence of Composite Endpoints [ Time Frame: Randomization up to Study Completion (Approximate 248 Weeks) ]

Locations (205)

Find similar trials in Alabaster, AL

Related Studies

• An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive a Kidney Transplant
  Recruiting · Regeneron Pharmaceuticals · Los Angeles, California
• Exercise and Monitoring With Post-Hospitalization Muscle Atrophy to Sustain Intrinsic Capacity and Strength
  Recruiting · VA Office of Research and Development · Aurora, Colorado
• Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
  PHASE3 · Recruiting · Novartis Pharmaceuticals · Birmingham, Alabama
• Non-interventional Pre-screening Protocol Aims to Evaluate Participants for Potential Trial Eligibility in Future Clinical Trials/Studies Focusing on Metabolic and Psychiatric Health.
  Recruiting · Clindove Research LLC · Brooklyn, New York