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A Study of Retatrutide (LY3437943) in Participants Without Type 2 Diabetes Who Have Obesity or Overweight
NCT07357415 · Eli Lilly and Company
In plain English
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Official title
A Phase 3b Study to Investigate the Efficacy and Safety of Different Retatrutide Dose Escalation Schemes in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Controlled, Double-Blind Trial
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 600 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-01-24
Estimated completion: 2028-11
Last updated: 2026-04-17
Interventions
Drug: Retatrutide
Primary outcomes
- • Percent Change from Baseline in Body Weight (Baseline, Week 104)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (35)
Arizona Research CenterRecruiting
Phoenix, Arizona, United States
Care Access - Huntington BeachRecruiting
Huntington Beach, California, United States
Los Angeles Institute for Metabolic ResearchRecruiting
Los Angeles, California, United States
New Horizon Research CenterRecruiting
Miami, Florida, United States
Encore Medical Research - WestonRecruiting
Weston, Florida, United States
Pacific Diabetes & Endocrine CenterRecruiting
Honolulu, Hawaii, United States
L-MARC Research CenterRecruiting
Louisville, Kentucky, United States
Brigham and Women's Hospital Diabetes ProgramRecruiting
Boston, Massachusetts, United States
Great Lakes Research Group, Inc.Recruiting
Bay City, Michigan, United States
NYC Research INCRecruiting
Long Island City, New York, United States
Weill Cornell Medical CollegeRecruiting
New York, New York, United States
Care Access - RaleighRecruiting
Raleigh, North Carolina, United States
New Phase Research and DevelopmentRecruiting
Knoxville, Tennessee, United States
Velocity Clinical Research, DallasRecruiting
Dallas, Texas, United States
Cedar Health Research - Texas Native HealthRecruiting
Dallas, Texas, United States
Cedar Health ResearchRecruiting
Dallas, Texas, United States
Cedar Health Research - Fort WorthRecruiting
Fort Worth, Texas, United States
Advanced Research InstituteRecruiting
Ogden, Utah, United States
Dominion Medical Associates, Inc.Recruiting
Richmond, Virginia, United States
CAMC Institute for Academic MedicineRecruiting
Charleston, West Virginia, United States
Cicemo SrlRecruiting
Buenos Aires, Argentina
CARDIAMET Investigaciones MédicasRecruiting
Buenos Aires, Argentina
Stat Research S.A.Recruiting
Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)Recruiting
Buenos Aires, Argentina
Centro Médico ViamonteRecruiting
Buenos Aires, Argentina
Aggarwal and Associates LimitedRecruiting
Brampton, Canada
Med Trust ResearchRecruiting
Courtice, Canada
Winterberry Research Inc.Recruiting
Hamilton, Canada
Diex Recherche Inc. Division JolietteRecruiting
Joliette, Canada
Milestone Research Inc.Recruiting
London, Canada
Diex Recherche Inc. Division QuebecRecruiting
Québec, Canada
Diex Recherche Inc. Division SherbrookeRecruiting
Sherbrooke, Canada
Canadian Phase OnwardRecruiting
Toronto, Canada
Dr. Anil K. Gupta Medicine Professional CorporationRecruiting
Toronto, Canada
C.I.C. Mauricie inc.Recruiting
Trois-Rivières, Canada