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
Status: Recruiting
Location: See all (35) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Arizona Research Center
NOT_YET_RECRUITING
Phoenix
California
Care Access - Huntington Beach
RECRUITING
Huntington Beach
Los Angeles Institute for Metabolic Research
RECRUITING
Los Angeles
Florida
New Horizon Research Center
RECRUITING
Miami
Encore Medical Research - Weston
NOT_YET_RECRUITING
Weston
Hawaii
Pacific Diabetes & Endocrine Center
RECRUITING
Honolulu
Kentucky
L-MARC Research Center
RECRUITING
Louisville
Massachusetts
Brigham and Women's Hospital Diabetes Program
NOT_YET_RECRUITING
Boston
Michigan
Great Lakes Research Group, Inc.
RECRUITING
Bay City
North Carolina
Care Access - Raleigh
RECRUITING
Raleigh
New York
NYC Research INC
RECRUITING
Long Island City
Weill Cornell Medical College
RECRUITING
New York
Tennessee
New Phase Research and Development
RECRUITING
Knoxville
Texas
Cedar Health Research
NOT_YET_RECRUITING
Dallas
Cedar Health Research - Texas Native Health
NOT_YET_RECRUITING
Dallas
Velocity Clinical Research, Dallas
RECRUITING
Dallas
Cedar Health Research - Fort Worth
NOT_YET_RECRUITING
Fort Worth
Utah
Advanced Research Institute
NOT_YET_RECRUITING
Ogden
Virginia
Dominion Medical Associates, Inc.
RECRUITING
Richmond
West Virginia
CAMC Institute for Academic Medicine
NOT_YET_RECRUITING
Charleston
Other Locations
Argentina
CARDIAMET Investigaciones Médicas
NOT_YET_RECRUITING
Buenos Aires
Centro de Investigaciones Metabólicas (CINME)
NOT_YET_RECRUITING
Buenos Aires
Centro Médico Viamonte
NOT_YET_RECRUITING
Buenos Aires
Cicemo Srl
NOT_YET_RECRUITING
Buenos Aires
Stat Research S.A.
NOT_YET_RECRUITING
Buenos Aires
Canada
Aggarwal and Associates Limited
NOT_YET_RECRUITING
Brampton
Med Trust Research
NOT_YET_RECRUITING
Courtice
Winterberry Research Inc.
NOT_YET_RECRUITING
Hamilton
Diex Recherche Inc. Division Joliette
NOT_YET_RECRUITING
Joliette
Milestone Research Inc.
NOT_YET_RECRUITING
London
Diex Recherche Inc. Division Quebec
NOT_YET_RECRUITING
Québec
Diex Recherche Inc. Division Sherbrooke
NOT_YET_RECRUITING
Sherbrooke
Canadian Phase Onward
NOT_YET_RECRUITING
Toronto
Dr. Anil K. Gupta Medicine Professional Corporation
NOT_YET_RECRUITING
Toronto
C.I.C. Mauricie inc.
NOT_YET_RECRUITING
Trois-rivières
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2026-01-24
Estimated Completion Date: 2028-11
Participants
Target number of participants: 600
Treatments
Experimental: Retatrutide Dose Escalation 1
Participants will receive retatrutide subcutaneously (SC)
Experimental: Retatrutide Dose Escalation 2
Participants will receive retatrutide SC
Experimental: Retatrutide Dose Escalation 3
Participants will receive retatrutide SC
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company