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New shot could boost opioid recovery, early trial hopes

NCT ID NCT07420283

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 04, 2026 · Updated 9 times

Summary

This Phase 2 trial tests whether adding brenipatide to standard buprenorphine treatment helps people with opioid use disorder stay off opioids longer. About 465 participants will receive either brenipatide or a placebo injection alongside their usual medication. The study measures weeks of abstinence through urine tests and self-reports over up to 144 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
brenipatide (also known as LY3537031)
What this could lead to
If it works, this could provide a new add-on treatment to help people with opioid use disorder stay abstinent longer during early recovery.
What could go wrong
This is an early Phase 2 trial, so results are uncertain. The added benefit over standard buprenorphine alone may be small or none, and side effects of brenipatide are not yet fully known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 465 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

opiate dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Opioid-use disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    59 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Accel Research Sites - Lakeland Clinical Research Unit

    RECRUITING

    Lakeland, Florida, 33803, United States

  • Adams Clinical Boston

    RECRUITING

    Boston, Massachusetts, 02116, United States

  • Adams Clinical Bronx

    RECRUITING

    The Bronx, New York, 10461, United States

  • Adams Clinical Dallas

    RECRUITING

    DeSoto, Texas, 75115, United States

  • Adams Clinical Harlem

    RECRUITING

    New York, New York, 10029, United States

  • Adams Clinical Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Adams Clinical Watertown

    RECRUITING

    Watertown, Massachusetts, 02472, United States

  • Advanced Research for Health Improvement, LLC

    RECRUITING

    Naples, Florida, 34102, United States

  • Ark Clinical Research - Fountain Valley

    RECRUITING

    Fountain Valley, California, 92708, United States

  • Avera Research Institute - Sioux Falls

    RECRUITING

    Sioux Falls, South Dakota, 57108, United States

  • Better Years Ahead Medical Center

    RECRUITING

    Tampa, Florida, 33614, United States

  • Bioluminux - London

    RECRUITING

    London, SE6 4LF, United Kingdom

  • Bioluminux - Southampton

    RECRUITING

    Southampton, SO15 2AQ, United Kingdom

  • Bioluminux - Wolverhampton

    RECRUITING

    Wolverhampton, WV9 5HB, United Kingdom

  • Bioluminux Clinical Research - Milton Keynes

    RECRUITING

    Milton Keynes, MK15 0DU, United Kingdom

  • Biopharma Informatic, LLC

    RECRUITING

    Houston, Texas, 77043, United States

  • Boston Medical Center

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02118, United States

  • Bradenton Research Center, Inc.

    RECRUITING

    Bradenton, Florida, 34205, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Brown University School of Public Health

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • CaRe Clinic

    RECRUITING

    Calgary, T2N 4L7, Canada

  • Carilion Clinic

    RECRUITING

    Roanoke, Virginia, 24014, United States

  • Center on Substance Use and Health (CSUH)

    RECRUITING

    San Francisco, California, 94102, United States

  • Centre for Addiction and Mental Health (CAMH)

    RECRUITING

    Toronto, M6J 1H4, Canada

  • Clerkenwell Health - Doncaster

    NOT_YET_RECRUITING

    Doncaster, DN4 8QN, United Kingdom

  • Clerkenwell Health - London - Welbeck Street

    NOT_YET_RECRUITING

    London, W1G 8DR, United Kingdom

  • Comprehensive Treatment Clinic

    RECRUITING

    Toronto, M4J 1M3, Canada

  • Greater Manchester Mental Health NHS Foundation Trust

    NOT_YET_RECRUITING

    Manchester, M25 3BL, United Kingdom

  • Indiana University Health Neuroscience Center

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Innovative Research Institute - Port Charlotte

    RECRUITING

    Port Charlotte, Florida, 33952, United States

  • K2 Medical Research - Daytona Beach

    RECRUITING

    Daytona Beach, Florida, 32114, United States

  • Kelowna Health and Memory Centre

    RECRUITING

    Kelowna, V1Y 5A8, Canada

  • Life Arc Research Centers - Miami

    RECRUITING

    Miami, Florida, 33126, United States

  • Malton Medical Group

    RECRUITING

    Mississauga, L4T 4J2, Canada

  • Maryland Treatment Centers - Avery Road Treatment Center

    RECRUITING

    Rockville, Maryland, 20853, United States

  • Maryland Treatment Centers - Mountain Manor Treatment Center

    RECRUITING

    Baltimore, Maryland, 21229, United States

  • Med Trust Research

    RECRUITING

    Courtice, L1E 2J5, Canada

  • Neuroscience Research Institute - West Palm Beach

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • NextPhase Research Florida - Hollywood

    RECRUITING

    Hollywood, Florida, 33024, United States

  • NoesisPharma - Phoenix - East Shea Boulevard

    RECRUITING

    Phoenix, Arizona, 85028, United States

  • Ohio Clinical Trials

    RECRUITING

    Columbus, Ohio, 43212, United States

  • Old Bank House Hillingdon Drug & Alcohol

    NOT_YET_RECRUITING

    Uxbridge, UB8 1JP, United Kingdom

  • Penn Medicine: University of Pennsylvania Health System

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Pillar Clinical Research- Little Rock

    RECRUITING

    Little Rock, Arkansas, 72204, United States

  • Providence Care

    RECRUITING

    Kingston, K7L 4X3, Canada

  • Queen Elizabeth University Hospital

    RECRUITING

    Glasgow, G51 4TF, United Kingdom

  • Re:Cognition Health - Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Research Works San Juan

    RECRUITING

    Guaynabo, 00966, Puerto Rico

  • Rivus Wellness and Research Institute

    NOT_YET_RECRUITING

    Oklahoma City, Oklahoma, 73112, United States

  • SKY Integrative Medical Center/SKYCRNG

    RECRUITING

    Ridgeland, Mississippi, 39157, United States

  • St Pancras Clinical Research

    RECRUITING

    London, EC2Y 8EA, United Kingdom

  • St Pancras Clinical Research - Eastbourne

    NOT_YET_RECRUITING

    Eastbourne, BN23 5UZ, United Kingdom

  • Surrey and Borders Partnership NHS Foundation Trust

    RECRUITING

    Chertsey, KT16 9AU, United Kingdom

  • The Medical Arts Health Research Group

    RECRUITING

    Kamloops, V2C 1K7, Canada

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

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Kentucky Chandler Medical Center

    RECRUITING

    Lexington, Kentucky, 40508, United States

  • University of Virginia Health System

    NOT_YET_RECRUITING

    Charlottesville, Virginia, 22903, United States

  • University of Washington - Harborview Medical Center

    RECRUITING

    Seattle, Washington, 98104, United States

  • Woodland International Research Group

    RECRUITING

    Little Rock, Arkansas, 72211, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.