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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Atherosclerotic Cardiovascular Disease (ASCVD), Chronic Kidney Disease (CKD)

In brief

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 facts

Study ID

NCT06383390

Run by

Eli Lilly and Company

People needed

10000

Starts

2024-04-30

Expected to finish

2029-02-01

Last updated by the study team

2026-07-20

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants may be without type 2 diabetes (T2D), or with T2D if their hemoglobin A1c (HbA1c) is 10% or lower
• Participants have established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD), as evidenced at least one of the following:
• Coronary artery disease
• Cerebrovascular disease
• Peripheral arterial disease
• Chronic kidney disease defined as:
• eGFR <45 millilitres/minute/1.73 meter squared (mL/min/1.73m\^2) and UACR >30 milligram/gram (mg/g) (0.030 mg/mg)
• eGFR <60 mL/min/1.73 m\^2 and UACR >100 mg/g (0.100 mg/mg), or
• eGFR <75 mL/min/1.73 m\^2 and UACR >300 mg/g (0.300 mg/mg) (eGFR is calculated by central lab based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine-cystatin c equation as determined by central lab)
• A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m\^2)

You may not qualify if…

• Diabetes related:
• Participants have Type 1 Diabetes or any history of diabetic ketoacidosis
• CV related:
• Participants have any of the following cardiovascular conditions ≤ 90 days prior to randomization:
• Myocardial infarction
• Acute coronary syndrome
• Stroke, or
• Coronary, peripheral, or carotid artery arterial revascularization procedure.
• Have acute decompensated heart failure requiring hospitalization.
• Have New York Heart Association (NYHA) Classification Class IV heart failure at screening
• Kidney related:
• Participants have an eGFR <20 mL/min/1.73 m\^2 at screening
• Have UACR >5000 mg/g (5.000 mg/mg) at screening
• Have received any form of dialysis ≤ 90 days from the date of randomization
• Have either undergone a kidney transplant or have a transplant procedure scheduled
• Other medical conditions:
• Participants have had or plan to have a surgical treatment for obesity,
• Have a history of chronic or acute pancreatitis
• Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome type 2
• Have a known clinically significant gastric emptying abnormality, such as severe gastroparesis or gastric outlet obstruction

Where it is running

• Central Research Associates — Birmingham, Alabama, United States
• Alliance for Multispecialty Research, LLC — Daphne, Alabama, United States
• Nephrology Consultants — Huntsville, Alabama, United States
• Alliance for Multispecialty Research, LLC — Mobile, Alabama, United States
• Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC — Gilbert, Arizona, United States
• Sun City Clinical Research — Glendale, Arizona, United States
• Arizona Kidney Disease & Hypertension Center (AKDHC) - Thunderbird — Glendale, Arizona, United States
• Helios Clinical Research - SAZ-PDV-026 — Paradise Valley, Arizona, United States
• Banner University Medical Center Phoenix — Phoenix, Arizona, United States
• Phoenix Clinical LLC — Phoenix, Arizona, United States
• Elite Clinical Studies, LLC — Phoenix, Arizona, United States
• Absolute Clinical Research — Phoenix, Arizona, United States
• Scottsdale Clinical Trials — Scottsdale, Arizona, United States
• Clinical Research Institute of Arizona (CRI) - Sun City West — Sun City West, Arizona, United States
• Synexus Clinical Research US, Inc./Orange Grove Family Practice — Tucson, Arizona, United States
• Cardiology and Medicine Clinic — Little Rock, Arkansas, United States
• Trident Clinical Research Services, Inc. — Apple Valley, California, United States
• Invivo - Bakersfield — Bakersfield, California, United States
• American Institute of Research — Beverly Hills, California, United States
• Hope Clinical Research, Inc. — Canoga Park, California, United States
• Valley Clinical Trials, Inc. — Covina, California, United States
• North Coast Cardiology — Encinitas, California, United States
• Neighborhood Healthcare Institute of Health — Escondido, California, United States
• HB Clinical Trials - Fountain Valley — Fountain Valley, California, United States
• Alabama Kidney Research — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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