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

Open to people ages 45 years and up

• 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/1.73m²) and UACR >30 milligram/gram (mg/g) (0.030 mg/mg)
    • eGFR <60 mL/min/1.73 m² and UACR >100 mg/g (0.100 mg/mg), or
    • eGFR <75 mL/min/1.73 m² 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/m²)

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 m² 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