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

Lilly

Status and phase: Enrolling; Phase 3

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

Treatments: Drug: Retatrutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06383390

2023-508630-34-00 (Other Identifier)

J1I-MC-GZBO (Other Identifier)

18584

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10,000 participants in 2 patient groups, including a placebo group

Retatrutide

Experimental group

Description:

Participants will receive escalated doses of retatrutide administered subcutaneously (SC) up to a maximum tolerated dose.

Treatment:

Drug: Retatrutide

Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo administered SC.

Treatment:

Drug: Placebo