Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Active Not Recruiting NCT06383390

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)

Sex: All
Ages: 45 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 10000
Sponsor: Eli Lilly and Company

Location: Alabama Kidney Research Alabaster Alabama

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.

Eligibility Criteria

Inclusion Criteria: * 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 \30 milligram/gram (mg/g) (0.030 mg/mg) * eGFR \100 mg/g (0.100 mg/mg), or * eGFR \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) Exclusion Criteria: 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 \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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06383390). StuddyBuddy aggregates publicly available trial information.