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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.