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

STUDY OVERVIEW

This study sponsored by Eli Lilly aims to investigate whether retatrutide can reduce the occurrence of severe heart-related issues or halt the decline in kidney function among adults with a body mass index of 27 kg/m² or higher and diagnosed with Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. Lasting approximately 5 years, participants will undergo up to 27 clinic visits with the study doctor.

STUDY GOALS

This study aims to evaluate whether retatrutide can reduce the incidence of serious cardiovascular complications or slow the progression of kidney disease in adults with a BMI of 27 kg/m² or higher, and diagnosed with established atherosclerotic cardiovascular disease and/or chronic kidney disease, over a period of approximately 5 years.

LOCATION

El Paso, Texas: El Paso Medical Research Institute

INCLUSION CRITERIA for all participants

  • FVC ≥45% predicted

  • FEV1/FVC ratio >0.70

  • DLco ≥30% and ≤90% predicted (Hgb corrected)

  • Minimum 6-minute walk test (6MWT) distance of 150 m with oxygen supplementation per protocol

  • Consideration of all medicinal treatment options and/or lung transplantation prior to study participation

Inclusion criteria

  • Body Mass Index (BMI) of ≥27.0 kg/m².

  • Participants with or without type 2 diabetes (T2D), unless their hemoglobin A1c (HbA1c) is 10% or lower.

  • Established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD), evidenced by:

    • Coronary artery disease, cerebrovascular disease, or peripheral arterial disease.

    • CKD defined as specific levels of estimated glomerular filtration rate (eGFR) and urinary albumin-to-creatinine ratio (UACR).

exclusion criteria

  • Type 1 Diabetes or history of diabetic ketoacidosis.

  • Recent cardiovascular events or procedures.

  • Acute decompensated heart failure or severe heart failure.

  • Severe kidney impairment or specific levels of UACR.

  • Recent dialysis, kidney transplant, or planned transplant.

  • History of surgical obesity treatment, pancreatitis, medullary thyroid carcinoma, or gastric abnormalities.

For more information, visit ClinicalTrials.gov.