The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Renal Function in Adults Living With Obesity (TRIUMPH-OUTCOMES)
Purpose
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.
Condition
- Overweight and Obesity
Eligibility
- Eligible Ages
- Over 45 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m^2) - Participants may be with or without type 2 diabetes (T2D) unless 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) - eGFR <60 mL/min/1.73 m^2 and UACR >100 mg/g, or - eGFR <75 mL/min/1.73 m^2 and UACR >300 mg/g (eGFR is calculated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin c equation as determined by central lab)
Exclusion Criteria
Diabetes related: - Participants have Type 1 Diabetes or 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 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Retatrutide |
Participants will receive escalated doses of retatrutide administered subcutaneously (SC) up to a maximum tolerated dose. |
|
Placebo Comparator Placebo |
Participants will receive matching placebo administered SC. |
|
Recruiting Locations
Fairway, Kansas 66205
More Details
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
Study Contact
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
ClinicalTrials.gov@lilly.com