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

NCT06383390

Active Not RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Atherosclerotic Cardiovascular Disease (ASCVD), Chronic Kidney Disease (CKD)

Interventions: Retatrutide, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia

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 overview

Sex: ALL

Age: 45 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 \<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

Locations (743)

Alabaster, Alabama, United States
Birmingham, Alabama, United States
Daphne, Alabama, United States
Huntsville, Alabama, United States
Mobile, Alabama, United States
Gilbert, Arizona, United States
Glendale, Arizona, United States
Glendale, Arizona, United States
Paradise Valley, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Sun City West, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Apple Valley, California, United States
Bakersfield, California, United States
Beverly Hills, California, United States
Canoga Park, California, United States
Covina, California, United States
Encinitas, California, United States
Escondido, California, United States
Fountain Valley, California, United States
Huntington Beach, California, United States
Irvine, California, United States
La Jolla, California, United States
Long Beach, California, United States
Long Beach, California, United States
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