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A Study of Brenipatide in Participants With Opioid Use Disorder
Sponsor: Eli Lilly and Company
Summary
The purpose of this study is to see if brenipatide, when compared to placebo, is safe and effective for participants with opioid use disorder, when used with buprenorphine with or without naloxone. The maximum potential duration of study participation for a participant in Part A is approximately 144 weeks, maximum potential duration of study participation for a participant in Part B is approximately 116 weeks. The actual duration will vary for each participant depending on the time of enrollment and the overall rate of study enrollment.
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study With a Separate Open-label Cohort to Evaluate the Efficacy and Safety of Brenipatide as Adjunctive Treatment to Transmucosal Buprenorphine With or Without Naloxone in Early Recovery of Participants With Opioid Use Disorder (RENEW-Op-1)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
465
Start Date
2026-02-13
Completion Date
2028-02
Last Updated
2026-03-04
Healthy Volunteers
No
Conditions
Interventions
Brenipatide
Administered SC
Placebo
Administered SC
Buprenorphine
Administered sublingual or buccal
Locations (56)
Parkway Medical Center
Birmingham, Alabama, United States
NoesisPharma - Phoenix - East Shea Boulevard
Phoenix, Arizona, United States
Woodland International Research Group
Little Rock, Arkansas, United States
Ark Clinical Research - Fountain Valley
Fountain Valley, California, United States
Center on Substance Use and Health (CSUH)
San Francisco, California, United States
UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
San Francisco, California, United States
Bradenton Research Center, Inc.
Bradenton, Florida, United States
K2 Medical Research - Daytona Beach
Daytona Beach, Florida, United States
NextPhase Research Florida - Hollywood
Hollywood, Florida, United States
Accel Research Sites - Lakeland Clinical Research Unit
Lakeland, Florida, United States
Life Arc Research Centers - Miami
Miami, Florida, United States
Advanced Research for Health Improvement, LLC
Naples, Florida, United States
Innovative Research Institute - Port Charlotte
Port Charlotte, Florida, United States
Better Years Ahead Medical Center
Tampa, Florida, United States
Neuroscience Research Institute - West Palm Beach
West Palm Beach, Florida, United States
Re:Cognition Health - Chicago
Chicago, Illinois, United States
Indiana University Health Neuroscience Center
Indianapolis, Indiana, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Maryland Treatment Centers - Mountain Manor Treatment Center
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Adams Clinical Boston
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Adams Clinical Watertown
Watertown, Massachusetts, United States
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, United States
Adams Clinical Harlem
New York, New York, United States
Adams Clinical Bronx
The Bronx, New York, United States
Ohio Clinical Trials
Columbus, Ohio, United States
Rivus Wellness and Research Institute
Oklahoma City, Oklahoma, United States
Adams Clinical Philadelphia
Philadelphia, Pennsylvania, United States
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Brown University School of Public Health
Providence, Rhode Island, United States
Avera Research Institute - Sioux Falls
Sioux Falls, South Dakota, United States
Adams Clinical Dallas
DeSoto, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Carilion Clinic
Roanoke, Virginia, United States
University of Washington - Harborview Medical Center
Seattle, Washington, United States
CaRe Clinic
Calgary, Canada
Med Trust Research
Courtice, Canada
Kelowna Health and Memory Centre
Kelowna, Canada
Providence Care
Kingston, Canada
Malton Medical Group
Mississauga, Canada
Comprehensive Treatment Clinic
Toronto, Canada
Centre for Addiction and Mental Health (CAMH)
Toronto, Canada
Gordon and Leslie Diamond Health Care Centre
Vancouver, Canada
Research Works San Juan
Guaynabo, Puerto Rico
Surrey and Borders Partnership NHS Foundation Trust
Chertsey, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
St Pancras Clinical Research
London, United Kingdom
Bioluminux - London
London, United Kingdom
Lambeth Drug and Alcohol Treatment Consortium
London, United Kingdom
Bioluminux Clinical Research - Milton Keynes
Milton Keynes, United Kingdom
Salford Royal Hospital
Salford, United Kingdom
Bioluminux - Southampton
Southampton, United Kingdom
Old Bank House Hillingdon Drug & Alcohol
Uxbridge, United Kingdom
Bioluminux - Wolverhampton
Wolverhampton, United Kingdom