The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
Actively Recruiting
About This Study
This Phase 3, randomized, double-blind, event-driven trial evaluates the efficacy of retatrutide in reducing major adverse cardiovascular events (MACE) and major adverse kidney events (MAKE). The study enrolls adults with a BMI ≥27 kg/m² who have established ASCVD, CKD, or both. Participants receive either subcutaneous retatrutide or placebo for approximately five years to assess long-term clinical outcomes. Primary endpoints focus on the incidence of serious cardiovascular complications and the progression of renal dysfunction. Secondary outcomes include changes in weight, eGFR, and UACR over the study period.
Who Can Participate?
✓ 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 <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)
✗ Exclusion Criteria
- •Diabetes related:
- •Participants have Type
- •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