Back to search results

A Study of Brenipatide for Opioid Use Disorder

This study is looking at whether brenipatide is safe and effective for people with opioid use disorder (OUD). You would also receive buprenorphine, which is a common medication for OUD. Researchers want to see if brenipatide, given as an injection under the skin (subcutaneous or SC), helps people stay abstinent from opioid use. Success in this study means having weeks where you don't use opioids, based on urine drug screens and your own reports. To join, you need to be between 18 and 75 years old, have a current OUD (mild, moderate, or severe), and be able to attend study visits and follow procedures, including self-injecting the study medication. The study aims to enroll 465 participants, but the current recruitment status is unclear.

Study design
This is an interventional study with two parts, Part A (double-blind with an open-label extension) and Part B (open-label treatment). You would be enrolled in only one part of the study.
What's involved
The maximum potential duration of study participation is approximately 144 weeks for Part A and 116 weeks for Part B. You would need to attend required study visits and be willing and able to self-inject the study intervention.
Compensation
Not stated in the trial record.
Follow-up
The primary goals of the study are measured from Week 13 up to Week 24, looking at abstinence from opioid use.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07420283

A Study of Brenipatide in Participants With Opioid Use Disorder

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Eli Lilly and Company
~465 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:BrenipatidePlaceboBuprenorphine

At a glance

Recruiting sites
48 of 58 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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)
Measured over Week 13 up to Week 24
+1 more outcome measured

Conditions

Opioid Use Disorder

Explore related trials

Opioid Use Disorder

Where it's being run

58 sites across 22 states
United Kingdom11
Florida9
Canada8
Massachusetts4
California3
Arkansas2
Maryland2
New York2

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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
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

What this trial measures

  • 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)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 TLFBWeek 13 up to Week 24