A Study of Brenipatide in Participants With Opioid Use Disorder

Last updated: May 13, 2026
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

Opioid Use Disorder

Treatment

Buprenorphine

Brenipatide

Placebo

Clinical Study ID

NCT07420283
27348
J2S-MC-GZMG
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a current mild, moderate or severe opioid use disorder (OUD)

  • Are reliable and willing to make themselves available for the duration of the study (for example, are not incarcerated, not homeless) and attend required study visits,and are willing and able to follow study procedures as required, such as

  • self-inject study intervention Note: Participants who are not able to performthe injections must have the assistance of a support person trained toadminister the study intervention

  • store and use the provided study intervention as directed

  • maintain electronic or paper study diaries, as applicable, and

  • complete the required questionnaires

  • Are intermittently using non-legal, non-prescribed opioids

  • Are taking buprenorphine for treatment on OUD

Exclusion

Exclusion Criteria:

  • Evidence of other substance use disorder(s) within 180 days of screening, except thefollowing are permitted: any level tobacco use disorder, mild-to-moderate alcohol ormild-to-moderate cannabis use disorder

Note: any level of caffeine use is allowed

  • Are actively suicidal or deemed a significant risk for suicide

  • Have a history of advanced liver disease (including advanced liver fibrosis orcirrhosis or alcohol-associated hepatitis based on either prior liver histology orimaging studies, such as transient elastography, ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI), or Enhanced Liver Fibrosis score

  • Have participated in a clinical study and received active treatment, or unknown ifthey received active treatment, within 90 days or 5 half-lives (whichever is longer)before screening

  • Had opioid overdose in past 6 months prior to screening

  • Have a lifetime history or current diagnosis of the following:

  • schizophrenia or other psychotic disorder

  • bipolar disorder

  • borderline personality disorder

  • any eating disorder

  • Have type 1 diabetes mellitus, or a history of ketoacidosis, or hyperosmolar state,or coma

Study Design

Total Participants: 465
Treatment Group(s): 3
Primary Treatment: Buprenorphine
Phase: 2
Study Start date:
February 13, 2026
Estimated Completion Date:
March 31, 2028

Study 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.

Connect with a study center

  • CaRe Clinic

    Calgary, T2N 4L7
    Canada

    Site Not Available

  • CaRe Clinic

    Calgary 5913490, T2N 4L7
    Canada

    Site Not Available

  • Med Trust Research

    Courtice, L1E 2J5
    Canada

    Active - Recruiting

  • Med Trust Research

    Courtice 5930897, L1E 2J5
    Canada

    Site Not Available

  • Kelowna Health and Memory Centre

    Kelowna, V1Y 5A8
    Canada

    Site Not Available

  • Providence Care

    Kingston, K7L 4X3
    Canada

    Site Not Available

  • Providence Care

    Kingston 5992500, K7L 4X3
    Canada

    Site Not Available

  • Malton Medical Group

    Mississauga, L4T 4J2
    Canada

    Active - Recruiting

  • Malton Medical Group

    Mississauga 6075357, L4T 4J2
    Canada

    Site Not Available

  • Centre for Addiction and Mental Health (CAMH)

    Toronto, M6J 1H4
    Canada

    Site Not Available

  • Comprehensive Treatment Clinic

    Toronto, M4J 1M3
    Canada

    Active - Recruiting

  • Centre for Addiction and Mental Health (CAMH)

    Toronto 6167865, M6J 1H4
    Canada

    Site Not Available

  • Comprehensive Treatment Clinic

    Toronto 6167865, M4J 1M3
    Canada

    Site Not Available

  • Gordon and Leslie Diamond Health Care Centre

    Vancouver, V5Z 1M9
    Canada

    Site Not Available

  • Gordon and Leslie Diamond Health Care Centre

    Vancouver 6173331, V5Z 1M9
    Canada

    Site Not Available

  • Research Works San Juan

    Guaynabo, 00966
    Puerto Rico

    Site Not Available

  • Research Works San Juan

    Guaynabo 4565119, 00966
    Puerto Rico

    Site Not Available

  • Surrey and Borders Partnership NHS Foundation Trust

    Chertsey, KT16 9AU
    United Kingdom

    Active - Recruiting

  • Surrey and Borders Partnership NHS Foundation Trust

    Chertsey 2653239, KT16 9AU
    United Kingdom

    Site Not Available

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF
    United Kingdom

    Site Not Available

  • Queen Elizabeth University Hospital

    Glasgow 2648579, G51 4TF
    United Kingdom

    Site Not Available

  • Bioluminux - London

    London, SE6 4LF
    United Kingdom

    Site Not Available

  • Lambeth Drug and Alcohol Treatment Consortium

    London, SW9 8DG
    United Kingdom

    Site Not Available

  • St Pancras Clinical Research

    London, EC2Y 8EA
    United Kingdom

    Site Not Available

  • Bioluminux - London

    London 2643743, SE6 4LF
    United Kingdom

    Site Not Available

  • Lambeth Drug and Alcohol Treatment Consortium

    London 2643743, SW9 8DG
    United Kingdom

    Site Not Available

  • Bioluminux Clinical Research - Milton Keynes

    Milton Keynes, MK15 0DU
    United Kingdom

    Site Not Available

  • Bioluminux Clinical Research - Milton Keynes

    Milton Keynes 2642465, MK15 0DU
    United Kingdom

    Site Not Available

  • Salford Royal Hospital

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • Salford Royal Hospital

    Salford 2638671, M6 8HD
    United Kingdom

    Site Not Available

  • Bioluminux - Southampton

    Southampton, SO15 2AQ
    United Kingdom

    Site Not Available

  • Bioluminux - Southampton

    Southampton 2637487, SO15 2AQ
    United Kingdom

    Site Not Available

  • Old Bank House Hillingdon Drug & Alcohol

    Uxbridge, UB8 1JP
    United Kingdom

    Site Not Available

  • Bioluminux - Wolverhampton

    Wolverhampton, WV9 5HB
    United Kingdom

    Site Not Available

  • Bioluminux - Wolverhampton

    Wolverhampton 2633691, WV9 5HB
    United Kingdom

    Site Not Available

  • Parkway Medical Center

    Birmingham, Alabama 35215
    United States

    Site Not Available

  • Parkway Medical Center

    Birmingham 4049979, Alabama 4829764 35215
    United States

    Site Not Available

  • NoesisPharma - Phoenix - East Shea Boulevard

    Phoenix, Arizona 85028
    United States

    Active - Recruiting

  • NoesisPharma - Phoenix - East Shea Boulevard

    Phoenix 5308655, Arizona 5551752 85028
    United States

    Site Not Available

  • Pillar Clinical Research- Little Rock

    Little Rock, Arkansas 72204
    United States

    Site Not Available

  • Woodland International Research Group

    Little Rock, Arkansas 72211
    United States

    Active - Recruiting

  • Woodland International Research Group

    Little Rock 4119403, Arkansas 4099753 72211
    United States

    Site Not Available

  • Ark Clinical Research - Fountain Valley

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Center on Substance Use and Health (CSUH)

    San Francisco, California 94102
    United States

    Site Not Available

  • UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay

    San Francisco, California 94158
    United States

    Active - Recruiting

  • Ark Clinical Research - Fountain Valley

    Fountain Valley 5350207, California 5332921 92708
    United States

    Site Not Available

  • Center on Substance Use and Health (CSUH)

    San Francisco 5391959, California 5332921 94102
    United States

    Site Not Available

  • UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay

    San Francisco 5391959, California 5332921 94158
    United States

    Site Not Available

  • Bradenton Research Center, Inc.

    Bradenton, Florida 34205
    United States

    Active - Recruiting

  • K2 Medical Research - Daytona Beach

    Daytona Beach, Florida 32114
    United States

    Active - Recruiting

  • NextPhase Research Florida - Hollywood

    Hollywood, Florida 33024
    United States

    Active - Recruiting

  • Accel Research Sites - Lakeland Clinical Research Unit

    Lakeland, Florida 33803
    United States

    Active - Recruiting

  • Life Arc Research Centers - Miami

    Miami, Florida 33126
    United States

    Active - Recruiting

  • Advanced Research for Health Improvement, LLC

    Naples, Florida 34102
    United States

    Active - Recruiting

  • Innovative Research Institute - Port Charlotte

    Port Charlotte, Florida 33952
    United States

    Active - Recruiting

  • Better Years Ahead Medical Center

    Tampa, Florida 33614
    United States

    Active - Recruiting

  • Neuroscience Research Institute - West Palm Beach

    West Palm Beach, Florida 33407
    United States

    Active - Recruiting

  • Bradenton Research Center, Inc.

    Bradenton 4148708, Florida 4155751 34205
    United States

    Site Not Available

  • K2 Medical Research - Daytona Beach

    Daytona Beach 4152872, Florida 4155751 32114
    United States

    Site Not Available

  • NextPhase Research Florida - Hollywood

    Hollywood 4158928, Florida 4155751 33024
    United States

    Site Not Available

  • Accel Research Sites - Lakeland Clinical Research Unit

    Lakeland 4161438, Florida 4155751 33803
    United States

    Site Not Available

  • Life Arc Research Centers - Miami

    Miami 4164138, Florida 4155751 33126
    United States

    Site Not Available

  • Advanced Research for Health Improvement, LLC

    Naples 4165565, Florida 4155751 34102
    United States

    Site Not Available

  • Innovative Research Institute - Port Charlotte

    Port Charlotte 4169130, Florida 4155751 33952
    United States

    Site Not Available

  • Better Years Ahead Medical Center

    Tampa 4174757, Florida 4155751 33614
    United States

    Site Not Available

  • Neuroscience Research Institute - West Palm Beach

    West Palm Beach 4177887, Florida 4155751 33407
    United States

    Site Not Available

  • Re:Cognition Health - Chicago

    Chicago, Illinois 60611
    United States

    Suspended

  • Re:Cognition Health - Chicago

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Indiana University Health Neuroscience Center

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Indiana University Health Neuroscience Center

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Site Not Available

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky 40508
    United States

    Site Not Available

  • University of Kentucky Chandler Medical Center

    Lexington 4297983, Kentucky 6254925 40508
    United States

    Site Not Available

  • Maryland Treatment Centers - Mountain Manor Treatment Center

    Baltimore, Maryland 21229
    United States

    Active - Recruiting

  • Maryland Treatment Centers - Avery Road Treatment Center

    Rockville, Maryland 20853
    United States

    Site Not Available

  • Maryland Treatment Centers - Mountain Manor Treatment Center

    Baltimore 4347778, Maryland 4361885 21229
    United States

    Site Not Available

  • Adams Clinical Boston

    Boston, Massachusetts 02116
    United States

    Active - Recruiting

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Adams Clinical Watertown

    Watertown, Massachusetts 02472
    United States

    Active - Recruiting

  • Adams Clinical Boston

    Boston 4930956, Massachusetts 6254926 02116
    United States

    Site Not Available

  • Boston Medical Center

    Boston 4930956, Massachusetts 6254926 02118
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Adams Clinical Watertown

    Watertown 4954611, Massachusetts 6254926 02472
    United States

    Site Not Available

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland, Mississippi 39157
    United States

    Active - Recruiting

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland 4443296, Mississippi 4436296 39157
    United States

    Site Not Available

  • Adams Clinical Harlem

    New York, New York 10029
    United States

    Active - Recruiting

  • Adams Clinical Bronx

    The Bronx, New York 10461
    United States

    Active - Recruiting

  • Adams Clinical Harlem

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Adams Clinical Bronx

    The Bronx 5110266, New York 5128638 10461
    United States

    Site Not Available

  • Ohio Clinical Trials

    Columbus, Ohio 43212
    United States

    Active - Recruiting

  • Ohio Clinical Trials

    Columbus 4509177, Ohio 5165418 43212
    United States

    Site Not Available

  • Rivus Wellness and Research Institute

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Rivus Wellness and Research Institute

    Oklahoma City 4544349, Oklahoma 4544379 73112
    United States

    Site Not Available

  • Adams Clinical Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Penn Medicine: University of Pennsylvania Health System

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Adams Clinical Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Penn Medicine: University of Pennsylvania Health System

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Brown University School of Public Health

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • Brown University School of Public Health

    Providence 5224151, Rhode Island 5224323 02903
    United States

    Site Not Available

  • Avera Research Institute - Sioux Falls

    Sioux Falls, South Dakota 57108
    United States

    Active - Recruiting

  • Avera Research Institute - Sioux Falls

    Sioux Falls 5231851, South Dakota 5769223 57108
    United States

    Site Not Available

  • Adams Clinical Dallas

    DeSoto, Texas 75115
    United States

    Active - Recruiting

  • Biopharma Informatic, LLC

    Houston, Texas 77043
    United States

    Active - Recruiting

  • Adams Clinical Dallas

    DeSoto 4685524, Texas 4736286 75115
    United States

    Site Not Available

  • Biopharma Informatic, LLC

    Houston 4699066, Texas 4736286 77043
    United States

    Site Not Available

  • University of Virginia Health System

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Carilion Clinic

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • University of Virginia Health System

    Charlottesville 4752031, Virginia 6254928 22903
    United States

    Site Not Available

  • Carilion Clinic

    Roanoke 4782167, Virginia 6254928 24014
    United States

    Site Not Available

  • University of Washington - Harborview Medical Center

    Seattle, Washington 98104
    United States

    Active - Recruiting

  • University of Washington - Harborview Medical Center

    Seattle 5809844, Washington 5815135 98104
    United States

    Site Not Available

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