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

ID#: NCT06383390

Age: 45 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: April 30, 2024

End Date: February 01, 2029

Contact Information:
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
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:

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 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
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