A Study of Brenipatide in Participants With Opioid Use Disorder

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Opioid Use Disorder

In brief

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.

Key facts

Study ID

NCT07420283

Run by

Eli Lilly and Company

People needed

465

Starts

2026-02-13

Expected to finish

2028-03-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NoesisPharma - Phoenix - East Shea Boulevard — Phoenix, Arizona, United States (enrolling)
• Woodland International Research Group — Little Rock, Arkansas, United States (enrolling)
• Ark Clinical Research - Fountain Valley — Fountain Valley, California, United States (enrolling)
• Pillar Clinical Research- Little Rock — Little Rock, Arkansas, United States (enrolling)
• UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay — San Francisco, California, United States (enrolling)
• Bradenton Research Center, Inc. — Bradenton, Florida, United States (enrolling)
• K2 Medical Research - Daytona Beach — Daytona Beach, Florida, United States (enrolling)
• NextPhase Research Florida - Hollywood — Hollywood, Florida, United States (enrolling)
• Accel Research Sites - Lakeland Clinical Research Unit — Lakeland, Florida, United States (enrolling)
• Center on Substance Use and Health (CSUH) — San Francisco, California, United States (enrolling)
• Advanced Research for Health Improvement, LLC — Naples, Florida, United States (enrolling)
• Innovative Research Institute - Port Charlotte — Port Charlotte, Florida, United States (enrolling)
• Better Years Ahead Medical Center — Tampa, Florida, United States (enrolling)
• Neuroscience Research Institute - West Palm Beach — West Palm Beach, Florida, United States (enrolling)
• Re:Cognition Health - Chicago — Chicago, Illinois, United States (enrolling)
• Indiana University Health Neuroscience Center — Indianapolis, Indiana, United States (enrolling)
• University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States (enrolling)
• Maryland Treatment Centers - Mountain Manor Treatment Center — Baltimore, Maryland, United States (enrolling)
• Maryland Treatment Centers - Avery Road Treatment Center — Rockville, Maryland, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Adams Clinical Boston — Boston, Massachusetts, United States (enrolling)
• Life Arc Research Centers - Miami — Miami, Florida, United States (enrolling)
• Adams Clinical Watertown — Watertown, Massachusetts, United States (enrolling)
• SKY Integrative Medical Center/SKYCRNG — Ridgeland, Mississippi, United States (enrolling)
• Adams Clinical Harlem — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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