A Study of Retatrutide (LY3437943) in Participants Without Type 2 Diabetes Who Have Obesity or Overweight (TRIUMPH-9)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Overweight; Obesity

Treatments: Drug: Retatrutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07357415

27795

J1I-MC-GZQL (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy and safety of different retatrutide dose escalation schemes in participants without type 2 diabetes who have obesity or overweight. Participation in the study will last about 113 weeks.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a Body Mass Index (BMI) at screening

  • ≥ 30 kilogram per square meter (kg/m2) OR
  • ≥ 27 kg/m2 with presence of at least one of the following weight-related conditions at screening: 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 kilograms (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:

  • heart attack
  • stroke
  • hospitalization for unstable angina or 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

---

600 participants in 3 patient groups

Retatrutide Dose Escalation 1

Experimental group

Description:

Participants will receive retatrutide subcutaneously (SC)

Treatment:

Drug: Retatrutide

Retatrutide Dose Escalation 2

Experimental group

Description:

Participants will receive retatrutide SC

Treatment:

Drug: Retatrutide

Retatrutide Dose Escalation 3

Experimental group

Description:

Participants will receive retatrutide SC

Treatment:

Drug: Retatrutide