A Study of Retatrutide (LY3437943) in Participants With Obesity or Overweight (TRIUMPH-8)

Lilly

Status and phase: Not yet enrolling; Phase 3

Conditions: Overweight; Obesity

Treatments: Drug: Placebo; Drug: Retatrutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07232719

J1I-MC-GZQJ (Other Identifier)

27769

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of retatrutide compared with placebo for body weight reduction.

Participation in the study will last about 65 weeks and may include about 18 visits.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a body mass index (BMI) of:

  • ≥30 kilogram per square meter (kg/m2) OR
  • ≥27 kg/m2 with at least one of the following weight-related conditions: high blood pressure, abnormal levels of lipid, obstructive sleep apnea, heart disease

• Have at least one unsuccessful attempt to lose weight by dieting

Exclusion criteria

• Have a self-reported change in body weight >5 kg (11 pounds) within 90 days before screening

• Have a prior or planned surgical treatment for obesity

• Have type 1 diabetes or type 2 diabetes

• Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)

• Have had within the past 90 days before screening

  • acute myocardial infarction
  • cerebrovascular accident (stroke)
  • hospitalization for unstable angina, or
  • hospitalization due to congestive heart failure

• Have New York Heart Association Functional Classification Class IV congestive heart failure

• Have a history of chronic or acute pancreatitis

• Have taken weight loss drugs, including over-the counter medications within 90 days prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 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 SC

Treatment:

Drug: Placebo