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RecruitingPhase 2

A Study of Brenipatide in Participants With Opioid Use Disorder

Eli Lilly and Company · NCT07420283

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
465
US sites recruiting
36
Study start
February 13, 2026
Record last updated
October 7, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Brenipatide; Placebo; Buprenorphine

Conditions: Opioid Use Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • NoesisPharma - Phoenix - East Shea Boulevard

    Phoenix, AZ 85028

    Site contact: John Prater

  • Pillar Clinical Research- Little Rock

    Little Rock, AR 72204

    Site contact: Leslie Smith

  • Woodland International Research Group

    Little Rock, AR 72211

    Site contact: 501-221-8681

  • Ark Clinical Research - Fountain Valley

    Fountain Valley, CA 92708

    Site contact: 714-988-2021

  • Center on Substance Use and Health (CSUH)

    San Francisco, CA 94102

    Site contact: Phillip Coffin

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

    San Francisco, CA 94158

    Site contact: Khaled Moussawi

  • Bradenton Research Center, Inc.

    Bradenton, FL 34205

    Site contact: 941-708-0005

  • K2 Medical Research - Daytona Beach

    Daytona Beach, FL 32114

    Site contact: Esteban Olivera

  • NextPhase Research Florida - Hollywood

    Hollywood, FL 33024

    Site contact: Peter Ventre

  • Accel Research Sites - Lakeland Clinical Research Unit

    Lakeland, FL 33803

    Site contact: 863-940-2087

  • Life Arc Research Centers - Miami

    Miami, FL 33126

    Site contact: 305-874-7401

  • Advanced Research for Health Improvement, LLC

    Naples, FL 34102

    Site contact: 239-230-2021

  • Innovative Research Institute - Port Charlotte

    Port Charlotte, FL 33952

    Site contact: 941-505-2100

  • Better Years Ahead Medical Center

    Tampa, FL 33614

    Site contact: 813-709-8299

  • Neuroscience Research Institute - West Palm Beach

    West Palm Beach, FL 33407

    Site contact: Danesh Alam

  • Re:Cognition Health - Chicago

    Chicago, IL 60611

    Site contact: Abid Nazeer

  • Indiana University Health Neuroscience Center

    Indianapolis, IN 46202

    Site contact: Michael Bushey

  • University of Kentucky Chandler Medical Center

    Lexington, KY 40508

    Site contact: Shanna Babalonis

  • Maryland Treatment Centers - Mountain Manor Treatment Center

    Baltimore, MD 21229

    Site contact: Marc Fishman

  • Maryland Treatment Centers - Avery Road Treatment Center

    Rockville, MD 20853

    Site contact: Marc Fishman

  • Brigham and Women's Hospital

    Boston, MA 02115

    Site contact: Joji Suzuki

  • Adams Clinical Boston

    Boston, MA 02116

    Site contact: Darin Dougherty

  • Boston Medical Center

    Boston, MA 02118

    Site contact: Alyssa Peterkin

  • Adams Clinical Watertown

    Watertown, MA 02472

    Site contact: 617-744-8542

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland, MS 39157

    Site contact: 601-567-1321

  • Adams Clinical Harlem

    New York, NY 10029

    Site contact: 917-423-67697

  • Adams Clinical Bronx

    The Bronx, NY 10461

    Site contact: Shama Farooq

  • Ohio Clinical Trials

    Columbus, OH 43212

    Site contact: 380-210-2424

  • Adams Clinical Philadelphia

    Philadelphia, PA 19104

    Site contact: Cassie Blanchard

  • Penn Medicine: University of Pennsylvania Health System

    Philadelphia, PA 19104

    Site contact: 610-639-3592

  • Brown University School of Public Health

    Providence, RI 02903

    Site contact: Carolina Haass-Koffler

  • Avera Research Institute - Sioux Falls

    Sioux Falls, SD 57108

    Site contact: 605-504-3154

  • Adams Clinical Dallas

    DeSoto, TX 75115

    Site contact: Benji Kurian

  • Biopharma Informatic, LLC

    Houston, TX 77043

    Site contact: 281-944-3610

  • Carilion Clinic

    Roanoke, VA 24014

    Site contact: 540-981-8025

  • University of Washington - Harborview Medical Center

    Seattle, WA 98104

    Site contact: Elenore Bhatraju

Study contacts (from the official record)

  • 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
A Study of Brenipatide in Participants With Opioid Use Disorder (NCT07420283) | Bored Studies