Brenipatide added to buprenorphine for people with opioid use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial enrolls people with mild-to-severe opioid use disorder who are taking buprenorphine and intermittently using non-prescribed opioids. It has two parts: Part A is a randomized, double-blind comparison of brenipatide versus placebo with an open-label extension, and Part B is an open-label treatment cohort. Participants must be able to self-inject the study drug (or have a trained helper), complete diaries and questionnaires, and attend regular clinic visits. Maximum participation may last up to about 144 weeks in Part A or 116 weeks in Part B depending on enrollment timing.

Why it matters

Who can join: the full rules

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

Where it's running

• NoesisPharma - Phoenix - East Shea Boulevard
  Phoenix, Arizona, United States Recruiting
• Pillar Clinical Research- Little Rock
  Little Rock, Arkansas, United States Recruiting
• Woodland International Research Group
  Little Rock, Arkansas, United States Recruiting
• Ark Clinical Research - Fountain Valley
  Fountain Valley, California, United States Recruiting
• Center on Substance Use and Health (CSUH)
  San Francisco, California, United States Recruiting
• UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
  San Francisco, California, United States Recruiting

+18 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CBD for Opioid Dependence and Pain on Buprenorphine

  This study tests whether different doses of cannabidiol (CBD) can affect pain and opioid cravings in adults with opioid use disorder who are on buprenorphine, using a short, randomized, placebo-controlled setup.

  Recruiting Early Phase 1 Yale University · West Haven, Connecticut · NCT07886606

• Cebranopadol for opioid withdrawal in adults with chronic pain

  This study tests whether cebranopadol can reduce withdrawal symptoms in adults with chronic pain who are physically dependent on prescribed opioids, compared with placebo.

  Recruiting at 2 sites Phase 2 Adneuris Therapeutics, Inc. · North Canton, Ohio and 1 other locations · NCT07874620

• emPath platform pilot to link and keep adults with opioid use disorder in care in Durham

  This pilot tests a mobile app and telemedicine approach to help adults with opioid use disorder start and stay in MOUD through community outreach in Durham, NC.

  Recruiting Duke University · Durham, North Carolina · NCT07810322

• CB1 Receptors in Opioid Use Disorder Measured with a PET Radioligand

  This study tests CB1 receptor availability in people with opioid use disorder starting opioid agonist therapy and compares them with healthy adults.

  Recruiting Phase 1 Yale University · New Haven, Connecticut · NCT07800520

• STORC: Training a support person plus patient navigation after birth

  We’re testing whether training a designated support person and using patient navigation after delivery helps people with opioid use disorder build recovery resources and stay in treatment.

  Recruiting Friends Research Institute, Inc. · Philadelphia, Pennsylvania · NCT07787039

• Personalized Addiction Treatment Enhancement for Opioid Use Disorder

  A digital platform run by peer recovery supporters will be tested to help adults with opioid use disorder who are on buprenorphine or methadone stay in treatment and improve outcomes.

  Recruiting Rhode Island Hospital · Providence, Rhode Island · NCT07778394

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.