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NCT07420283PHASE2Recruiting

A Study of Brenipatide in Participants With Opioid Use Disorder

Eli Lilly and Company

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

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 perform the injections must have the assistance of a support person trained to administer 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 Criteria: * Evidence of other substance use disorder(s) within 180 days of screening, except the following are permitted: any level tobacco use disorder, mild-to-moderate alcohol or mild-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 or cirrhosis or alcohol-associated hepatitis based on either prior liver histology or imaging 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 if they 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

Interventions

DRUG

Brenipatide

DRUG

Placebo

DRUG

Buprenorphine

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Opioid Use Disorder

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