A Study of Brenipatide in Participants With Opioid Use Disorder
Start Date
2/13/2026
Completion Date
3/1/2028
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.
Detailed Description
The study consists of 2 parts, each with its own participant cohort * Part A: double-blind treatment with open-label extension (OLE) * Part B: open-label treatment. Participants will be enrolled in only one part of the study.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
Brenipatide
Placebo
Buprenorphine
Conditions
Locations
NoesisPharma - Phoenix - East Shea Boulevard
Phoenix, Arizona 85028
United States
Pillar Clinical Research- Little Rock
Little Rock, Arkansas 72204
United States
Woodland International Research Group
Little Rock, Arkansas 72211
United States
Ark Clinical Research - Fountain Valley
Fountain Valley, California 92708
United States
Center on Substance Use and Health (CSUH)
San Francisco, California 94102
United States
UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
San Francisco, California 94158
United States
Bradenton Research Center, Inc.
Bradenton, Florida 34205
United States
K2 Medical Research - Daytona Beach
Daytona Beach, Florida 32114
United States
NextPhase Research Florida - Hollywood
Hollywood, Florida 33024
United States
Accel Research Sites - Lakeland Clinical Research Unit
Lakeland, Florida 33803
United States
Life Arc Research Centers - Miami
Miami, Florida 33126
United States
Advanced Research for Health Improvement, LLC
Naples, Florida 34102
United States
Innovative Research Institute - Port Charlotte
Port Charlotte, Florida 33952
United States
Better Years Ahead Medical Center
Tampa, Florida 33614
United States
Neuroscience Research Institute - West Palm Beach
West Palm Beach, Florida 33407
United States
Re:Cognition Health - Chicago
Chicago, Illinois 60611
United States
Indiana University Health Neuroscience Center
Indianapolis, Indiana 46202
United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky 40508
United States
Maryland Treatment Centers - Mountain Manor Treatment Center
Baltimore, Maryland 21229
United States
Maryland Treatment Centers - Avery Road Treatment Center
Rockville, Maryland 20853
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Adams Clinical Boston
Boston, Massachusetts 02116
United States
Boston Medical Center
Boston, Massachusetts 02118
United States
Adams Clinical Watertown
Watertown, Massachusetts 02472
United States
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi 39157
United States
Adams Clinical Harlem
New York, New York 10029
United States
Adams Clinical Bronx
The Bronx, New York 10461
United States
Ohio Clinical Trials
Columbus, Ohio 43212
United States
Rivus Wellness and Research Institute
Oklahoma City, Oklahoma 73112
United States
Adams Clinical Philadelphia
Philadelphia, Pennsylvania 19104
United States
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania 19104
United States
Brown University School of Public Health
Providence, Rhode Island 02903
United States
Avera Research Institute - Sioux Falls
Sioux Falls, South Dakota 57108
United States
Adams Clinical Dallas
DeSoto, Texas 75115
United States
Biopharma Informatic, LLC
Houston, Texas 77043
United States
University of Virginia Health System
Charlottesville, Virginia 22903
United States
Carilion Clinic
Roanoke, Virginia 24014
United States
University of Washington - Harborview Medical Center
Seattle, Washington 98104
United States
CaRe Clinic
Calgary, T2N 4L7
Canada
Med Trust Research
Courtice, L1E 2J5
Canada
The Medical Arts Health Research Group
Kamloops, V2C 1K7
Canada
Kelowna Health and Memory Centre
Kelowna, V1Y 5A8
Canada
Providence Care
Kingston, K7L 4X3
Canada
Malton Medical Group
Mississauga, L4T 4J2
Canada
Comprehensive Treatment Clinic
Toronto, M4J 1M3
Canada
Centre for Addiction and Mental Health (CAMH)
Toronto, M6J 1H4
Canada
Research Works San Juan
Guaynabo, 00966
Puerto Rico
Surrey and Borders Partnership NHS Foundation Trust
Chertsey, KT16 9AU
United Kingdom
St Pancras Clinical Research - Eastbourne
Eastbourne, BN23 5UZ
United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF
United Kingdom
St Pancras Clinical Research
London, EC2Y 8EA
United Kingdom
Bioluminux - London
London, SE6 4LF
United Kingdom
Lambeth Drug and Alcohol Treatment Consortium
London, SW9 8DG
United Kingdom
Greater Manchester Mental Health NHS Foundation Trust
Manchester, M25 3BL
United Kingdom
Bioluminux Clinical Research - Milton Keynes
Milton Keynes, MK15 0DU
United Kingdom
Bioluminux - Southampton
Southampton, SO15 2AQ
United Kingdom
Old Bank House Hillingdon Drug & Alcohol
Uxbridge, UB8 1JP
United Kingdom
Bioluminux - Wolverhampton
Wolverhampton, WV9 5HB
United Kingdom