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Purpose

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.

Conditions

Eligibility

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

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

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 subcutaneously (SC)
  • Drug: Retatrutide
    Administered SC
    Other names:
    • LY3437943
Experimental
Retatrutide Dose 2 		Participants will receive retatrutide SC
  • Drug: Retatrutide
    Administered SC
    Other names:
    • LY3437943
Placebo Comparator
Placebo 		Participants will receive placebo SC
  • Drug: Placebo
    Administered SC

Recruiting Locations

Artemis Institute for Clinical Research
Riverside, California 92503
Contact:
951-374-1190

Pharmasite Research, Inc.
Baltimore, Maryland 21208

Cedar Health Research - Euless
Euless, Texas 76040
Contact:
214-253-8170

Cedar Health Research - Fort Worth
Fort Worth, Texas 76132
Contact:
214-253-8170

Care Access - Houston
Houston, Texas 77054
Contact:
877-791-0656

IMA Clinical Research San Antonio
San Antonio, Texas 78229
Contact:
210-692-7157

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@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.