A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals With Obesity

Purpose

This is a study of retatrutide in participants with obesity. The main purpose is to learn more about how retatrutide maintains body weight loss. The study will have two treatment phases: an 80 week lead-in phase in which all participants will take retatrutide dose 1 and a 36 week randomized, double-blinded phase in which participants will either take retatrutide dose 1, retatrutide dose 2, or switch to placebo. Participation in the study will last around 125 weeks.

Condition

  • Obesity

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight

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 a prior or planned endoscopic procedure and/or device-based therapy for obesity - Have Type 1 Diabetes, Type 2 Diabetes, or any other type of 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Phase 3b
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Retatrutide Dose 1 		Participants will receive retatrutide dose 1 administered subcutaneously (SC) for 116 weeks
  • Drug: Retatrutide
    Administered SC
    Other names:
    • LY3437943
  • Drug: Placebo
    Administered SC
Experimental
Retatrutide Dose 1 to Retatrutide Dose 2 		Participants will receive retatrutide dose 1 administered SC for 80 weeks, then retatrutide dose 2 administered SC for an additional 36 weeks
  • Drug: Retatrutide
    Administered SC
    Other names:
    • LY3437943
Placebo Comparator
Retatrutide Dose 1 to Placebo 		Participants will receive retatrutide dose 1 administered SC for 80 weeks, then placebo administered SC for an additional 36 weeks
  • Drug: Retatrutide
    Administered SC
    Other names:
    • LY3437943
  • Drug: Placebo
    Administered SC

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
617-726-4400

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
clinical_inquiry_hub@lilly.com