A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease (TRIUMPH-3)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Obesity; Cardiovascular Diseases

Treatments: Drug: Retatrutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05882045

2023-503659-88-00 (Other Identifier)

18582

J1I-MC-GZBM (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy and safety of retatrutide once weekly in participants with obesity and established cardiovascular disease (CVD). The study will last about 113 weeks.

Enrollment: 1,800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a body mass index (BMI) ≥35.0 kilogram/square meter (kg/m²).

• Have established cardiovascular (CV) disease with at least 1 of the following:

  • prior myocardial infarction
  • prior ischemic or hemorrhagic stroke, or
  • symptomatic peripheral arterial disease

• Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight.

Exclusion criteria

• Have had acute myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure within 90 days prior to screening.
• Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
• Have a prior or planned surgical treatment of obesity.
• Have a change in body weight greater than 5 kg (11 pounds) within 90 days prior to screening.
• Have Type 1 diabetes.
• Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
• Have had pancreatitis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,800 participants in 3 patient groups, including a placebo group

Retatrutide Dose 1

Experimental group

Description:

Participants will receive retatrutide subcutaneously (SC).

Treatment:

Drug: Retatrutide

Retatrutide Dose 2

Experimental group

Description:

Participants will receive retatrutide SC.

Treatment:

Drug: Retatrutide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo.

Treatment:

Drug: Placebo