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

About

Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
45 Years
Maximum Age
N/A

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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Study Stats
Protocol No.
23-5265
Category
Endocrine and Metabolic Disorders
Genitourinary Disorders
Heart/Cardiovascular Diseases
Contact
Miriam Urrutia
Location
  • UCLA Torrance
  • UCLA Westwood
For Providers
NCT No.
NCT06383390
For detailed technical eligibility, visit ClinicalTrials.gov.