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Alpine Research Organization | Clinton, UT

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

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Lilly

Status and phase

Enrolling
Phase 3

Conditions

Overweight and Obesity

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

  • A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m^2)

  • Participants may be with or without type 2 diabetes (T2D) unless 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)
      • eGFR <60 mL/min/1.73 m^2 and UACR >100 mg/g, or
      • eGFR <75 mL/min/1.73 m^2 and UACR >300 mg/g (eGFR is calculated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin c equation as determined by central lab)

Exclusion criteria

Diabetes related:

  • Participants have Type 1 Diabetes or 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 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

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

Trial contacts and locations

708

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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