Recruiting

Phase 2

BrenipatideA Study of Brenipatide in Participants With Opioid Use Disorder

Sponsor:

Eli Lilly and Company

Code:

NCT07420283

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Brenipatide

Placebo

Buprenorphine

Study Details

Brief 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.

Conditions

Opioid Use Disorder

Study ID

NCT07420283

Start date

Feb 13, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

465 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A and Part B: Brenipatide + Buprenorphine Dose 1

Part A: Brenipatide administered subcutaneously (SC) + Buprenorphine administered sublingual or buccal.

Part B: Open-label Treatment: Participants will receive Brenipatide SC + Buprenorphine sublingual or buccal.

experimental: Part A: Brenipatide + Buprenorphine Dose 2

Brenipatide administered SC + Buprenorphine administered sublingual or buccal.

experimental: Part A: Brenipatide + Buprenorphine Dose 3

Brenipatide administered SC + Buprenorphine administered sublingual or buccal.

placebo comparator: Part A: Placebo + Buprenorphine

Placebo administered SC + Buprenorphine administered sublingual or buccal.

Interventions

Brenipatide

Administered SC

Placebo

Administered SC

Buprenorphine

Administered sublingual or buccal

Primary outcome measure

Percentage of Weeks of Abstinence from Opioid Use Defined by Both Negative Urine Drug Screen (UDS) and no Self-Report of Opioid use Based on Timeline Followback (TLFB) [ Time Frame: Week 13 up to Week 24 ]
Achievement of ≥80% Weeks of Abstinence from Opioid Use Defined by Both Negative UDS and no Self-Report of Opioid Use Based on TLFB [ Time Frame: Week 13 up to Week 24 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

1-317-615-4559 clinical_inquiry_hub@lilly.com

Locations

NoesisPharma - Phoenix - East Shea Boulevard

Recruiting

Phoenix, Arizona, United States, 85028

Principal Investigator:

John Prater

Pillar Clinical Research- Little Rock

Recruiting

Little Rock, Arkansas, United States, 72204

Principal Investigator:

Leslie Smith

Woodland International Research Group

Recruiting

Little Rock, Arkansas, United States, 72211

Contacts

501-221-8681

Principal Investigator:

George Konis

Ark Clinical Research - Fountain Valley

Recruiting

Fountain Valley, California, United States, 92708

Contacts

714-988-2021

Principal Investigator:

Justin Yanuck

Center on Substance Use and Health (CSUH)

Recruiting

San Francisco, California, United States, 94102

Principal Investigator:

Phillip Coffin

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

Recruiting

San Francisco, California, United States, 94158

Principal Investigator:

Khaled Moussawi

Bradenton Research Center, Inc.

Recruiting

Bradenton, Florida, United States, 34205

Contacts

941-708-0005

Principal Investigator:

Eric Folkens

K2 Medical Research - Daytona Beach

Recruiting

Daytona Beach, Florida, United States, 32114

Principal Investigator:

Esteban Olivera

NextPhase Research Florida - Hollywood

Recruiting

Hollywood, Florida, United States, 33024

Principal Investigator:

Peter Ventre

Accel Research Sites - Lakeland Clinical Research Unit

Recruiting

Lakeland, Florida, United States, 33803

Contacts

863-940-2087

Principal Investigator:

James Andersen

Life Arc Research Centers - Miami

Recruiting

Miami, Florida, United States, 33126

Contacts

305-874-7401

Principal Investigator:

Janny Rivera

Advanced Research for Health Improvement, LLC

Recruiting

Naples, Florida, United States, 34102

Contacts

239-230-2021

Principal Investigator:

Leonard Lado

Innovative Research Institute - Port Charlotte

Recruiting

Port Charlotte, Florida, United States, 33952

Contacts

941-505-2100

Principal Investigator:

Joseph Ravid

Better Years Ahead Medical Center

Recruiting

Tampa, Florida, United States, 33614

Contacts

813-709-8299

Principal Investigator:

Ana Suarez

Neuroscience Research Institute - West Palm Beach

Recruiting

West Palm Beach, Florida, United States, 33407

Principal Investigator:

Danesh Alam

Re:Cognition Health - Chicago

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Abid Nazeer

Indiana University Health Neuroscience Center

Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator:

Michael Bushey

University of Kentucky Chandler Medical Center

Recruiting

Lexington, Kentucky, United States, 40508

Principal Investigator:

Shanna Babalonis

Maryland Treatment Centers - Mountain Manor Treatment Center

Recruiting

Baltimore, Maryland, United States, 21229

Principal Investigator:

Marc Fishman

Maryland Treatment Centers - Avery Road Treatment Center

Recruiting

Rockville, Maryland, United States, 20853

Principal Investigator:

Marc Fishman

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Joji Suzuki

Adams Clinical Boston

Recruiting

Boston, Massachusetts, United States, 02116

Principal Investigator:

Darin Dougherty

Adams Clinical Watertown

Recruiting

Watertown, Massachusetts, United States, 02472

Contacts

617-744-8542

Principal Investigator:

Daniel Rutrick

SKY Integrative Medical Center/SKYCRNG

Recruiting

Ridgeland, Mississippi, United States, 39157

Contacts

601-567-1321

Principal Investigator:

Bob Hutchins

Adams Clinical Harlem

Recruiting

New York, New York, United States, 10029

Contacts

917-423-67697

Principal Investigator:

Rachel Noone

Adams Clinical Bronx

Recruiting

The Bronx, New York, United States, 10461

Principal Investigator:

Shama Farooq

Ohio Clinical Trials

Recruiting

Columbus, Ohio, United States, 43212

Contacts

380-210-2424

Principal Investigator:

Angela Eakin

Adams Clinical Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Cassie Blanchard

Penn Medicine: University of Pennsylvania Health System

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

610-639-3592

Principal Investigator:

Kyle Kampman

Brown University School of Public Health

Recruiting

Providence, Rhode Island, United States, 02903

Principal Investigator:

Carolina Haass-Koffler

Avera Research Institute - Sioux Falls

Recruiting

Sioux Falls, South Dakota, United States, 57108

Contacts

605-504-3154

Principal Investigator:

Vivek Anand

Adams Clinical Dallas

Recruiting

DeSoto, Texas, United States, 75115

Principal Investigator:

Benji Kurian

Biopharma Informatic, LLC

Recruiting

Houston, Texas, United States, 77043

Contacts

281-944-3610

Principal Investigator:

James Lai, MD

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

540-981-8025

Principal Investigator:

Albert Arias

University of Washington - Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98104

Principal Investigator:

Elenore Bhatraju

CaRe Clinic

Recruiting

Calgary, Canada, T2N 4L7

Contacts

587-955-3401

Principal Investigator:

Sumantra Ghosh

Med Trust Research

Recruiting

Courtice, Canada, L1E 2J5

Contacts

905-728-7915

Principal Investigator:

Hamilton Jeyaraj

The Medical Arts Health Research Group

Recruiting

Kamloops, Canada, V2C 1K7

Principal Investigator:

Dustin Janz

Kelowna Health and Memory Centre

Recruiting

Kelowna, Canada, V1Y 5A8

Principal Investigator:

Eugene Okorie

Providence Care

Recruiting

Kingston, Canada, K7L 4X3

Contacts

6135444900

Principal Investigator:

Roumen Milev

Malton Medical Group

Recruiting

Mississauga, Canada, L4T 4J2

Contacts

905-677-4200

Principal Investigator:

Brian Zidel

Comprehensive Treatment Clinic

Recruiting

Toronto, Canada, M4J 1M3

Principal Investigator:

Leonard Bienenstock

Centre for Addiction and Mental Health (CAMH)

Recruiting

Toronto, Canada, M6J 1H4

Principal Investigator:

Bernard Le Foll

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-04.