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