RecruitingPhase 3NCT07232719

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

A Phase 3b Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial


Sponsor

Eli Lilly and Company

Enrollment

250 participants

Start Date

Nov 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria12

  • 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

Interventions

DRUGRetatrutide

Administered SC

DRUGPlacebo

Administered SC


Locations(31)

Artemis Institute for Clinical Research

Riverside, California, United States

JEM Research Institute

Atlantis, Florida, United States

Headlands Research Orlando

Orlando, Florida, United States

Care Access - Tamarac

Tamarac, Florida, United States

Care Access - Arlington Heights

Arlington Heights, Illinois, United States

L-MARC Research Center

Louisville, Kentucky, United States

IMA Clinical Research Monroe - Armand

Monroe, Louisiana, United States

Pharmasite Research, Inc.

Baltimore, Maryland, United States

Clinical Research Professionals

Chesterfield, Missouri, United States

Clinvest Headlands Llc

Springfield, Missouri, United States

IMA Clinical Research Warren

Warren Township, New Jersey, United States

IMA Clinical Research Manhattan

New York, New York, United States

Trial Management Associates - Wilmington - Floral Parkway

Wilmington, North Carolina, United States

Cedar Health Research

Dallas, Texas, United States

Headlands Research-El Paso

El Paso, Texas, United States

Cedar Health Research - Euless

Euless, Texas, United States

Cedar Health Research - Fort Worth

Fort Worth, Texas, United States

Care Access - Houston

Houston, Texas, United States

IMA Clinical Research San Antonio

San Antonio, Texas, United States

FutureMeds - Birmingham

Birmingham, United Kingdom

Layton Medical Centre

Blackpool, United Kingdom

Bradford on Avon Health Centre

Bradford-on-Avon, United Kingdom

FutureMeds - Liverpool

Bromborough, United Kingdom

Cheadle Community Hospital

Cheadle, United Kingdom

HMC Health Group - Meadows Centre for Health

Hounslow, United Kingdom

St Bartholomew's Medical Centre

Oxford, United Kingdom

Atlantic Medical

Penzance, United Kingdom

The Adam Practice

Poole, United Kingdom

Woodstock Bower Surgery

Rotherham, United Kingdom

Rame Group Practice

Torpoint, United Kingdom

Albany House Medical Centre

Wellingborough, United Kingdom

View Full Details on ClinicalTrials.gov

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Visit

NCT07232719


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