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Brenipatide added to buprenorphine for people with opioid use disorder

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study With a Separate Open-label Cohort to Evaluate the Efficacy and Safety of Brenipatide as Adjunctive Treatment to Transmucosal Buprenorphine With or Without Naloxone in Early Recovery of Participants With Opioid Use Disorder (RENEW-Op-1)

Phase 2 Interventional Eli Lilly and Company · NCT07420283

This will test whether brenipatide, given with buprenorphine (with or without naloxone), is safe and helpful for people with opioid use disorder who still use non-prescribed opioids.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment465 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations57 sites (Phoenix, Arizona and 56 other locations)
Trial IDNCT07420283 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with mild, moderate, or severe opioid use disorder who are taking buprenorphine (with or without naloxone), intermittently using non-prescribed opioids, and who can attend long-term visits and self-inject or arrange for a trained helper are ideal candidates.

Not a fit: People not on buprenorphine, those with recent other substance use disorders, those who are incarcerated or unable to attend study visits, or who cannot perform or arrange injections are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, brenipatide could reduce opioid use or cravings and improve outcomes when added to buprenorphine treatment.

How similar studies have performed: Adding adjunct medications to buprenorphine has shown mixed results in prior research, and brenipatide represents a novel approach with limited prior data in opioid use disorder.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Phoenix, Arizona and 56 other locations

+7 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Opioid Use Disorder
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.