Early access
Sign in
Taking people in United StatesPhase 2

A Study of Brenipatide in Participants With Opioid Use Disorder

Key facts

Who runs it
Eli Lilly and Company
Where
Baltimore, Boston, Bradenton, Charleston, Charlottesville, Chicago, Columbus, Daytona Beach, DeSoto, Fountain Valley, Hollywood, Houston, Indianapolis, Lakeland, Lexington, Little Rock, Miami, Monroe, Naples, New York, Oklahoma City, Philadelphia, Phoenix, Port Charlotte, Providence, Ridgeland, Roanoke, Rockville, Rose Hill, San Francisco, Seattle, Sioux Falls, Snellville, Springfield, Tampa, The Bronx, Watertown, and West Palm Beach, United StatesSee the 46 sitesAlso in 3 other countries, 22 sites
Trial code
Status
Recruiting
Phase
Phase 2
People taking part
465 people, planned
Started
13 Feb 2026
Expected to end
Mar 2028
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Brenipatide
  • Placebo
  • Buprenorphine
Record updated
4 November 2026

Who can take part

Age
18 years to 75 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • 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
  • Are actively suicidal or deemed a significant risk for suicide

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in United States

Also in 3 other countries, 22 sites

  • Maryland Treatment Centers - Mountain Manor Treatment CenterBaltimore, United StatesContact: Marc Fishman (principal investigator)Taking people
  • Adams Clinical BostonBoston, United StatesContact: Darin Dougherty (principal investigator)Taking people
  • Boston Medical CenterBoston, United StatesContact: Alyssa Peterkin (principal investigator)Taking people
  • Brigham and Women's HospitalBoston, United StatesContact: Joji Suzuki (principal investigator)Taking people
  • Bradenton Research Center, Inc.Bradenton, United StatesContact: Eric Folkens (principal investigator)Taking people
  • Medical University of South CarolinaCharleston, United StatesContact: Larissa Mooney (principal investigator)Not yet recruiting
  • University of Virginia Health SystemCharlottesville, United StatesContact: Nassima Ait-Daoud Tiouririne (principal investigator)Taking people
  • Re:Cognition Health - ChicagoChicago, United StatesContact: Abid Nazeer (principal investigator)Taking people
  • Ohio Clinical TrialsColumbus, United StatesContact: Angela Eakin (principal investigator)Taking people
  • K2 Medical Research - Daytona BeachDaytona Beach, United StatesContact: Esteban Olivera (principal investigator)Taking people
  • Adams Clinical DallasDeSoto, United StatesContact: Benji Kurian (principal investigator)Taking people
  • Ark Clinical Research, Fountain ValleyFountain Valley, United StatesContact: Justin Yanuck (principal investigator)Taking people
  • NextPhase Research Florida - HollywoodHollywood, United StatesContact: Peter Ventre (principal investigator)Taking people
  • Biopharma Informatic, LLCHouston, United StatesContact: James Lai, MD (principal investigator)Taking people
  • Indiana University Health Neuroscience CenterIndianapolis, United StatesContact: Michael Bushey (principal investigator)Taking people
  • Accel Research Sites - Lakeland Clinical Research UnitLakeland, United StatesContact: James Andersen (principal investigator)Taking people
  • University of Kentucky Chandler Medical CenterLexington, United StatesContact: Shanna Babalonis (principal investigator)Taking people
  • Pillar Clinical Research - Little RockLittle Rock, United StatesContact: Leslie Smith (principal investigator)Taking people
  • Woodland International Research GroupLittle Rock, United StatesContact: George Konis (principal investigator)Taking people
  • Life Arc Research Centers - MiamiMiami, United StatesContact: Janny Rivera (principal investigator)Taking people
  • Wellness Research CenterMiami, United StatesContact: Emilio Mantero-Atienza (principal investigator)Not yet recruiting
  • Monroe Biomedical ResearchMonroe, United StatesContact: Rasheed Onafuye (principal investigator)Not yet recruiting
  • Advanced Research for Health Improvement LLCNaples, United StatesContact: Leonard Lado (principal investigator)Taking people
  • Adams Clinical HarlemNew York, United StatesContact: Rachel Noone (principal investigator)Taking people
  • CNS VeritasNew York, United StatesContact: Leonardo Vando (principal investigator)Not yet recruiting
  • Rivus Wellness and Research InstituteOklahoma City, United StatesContact: Marvin Peyton (principal investigator)Not yet recruiting
  • Adams Clinical PhiladelphiaPhiladelphia, United StatesContact: Cassie Blanchard (principal investigator)Taking people
  • Penn Medicine: University of Pennsylvania Health SystemPhiladelphia, United StatesContact: Kyle Kampman (principal investigator)Taking people
  • NoesisPharma - Phoenix - East Shea BoulevardPhoenix, United StatesContact: John Prater (principal investigator)Taking people
  • Innovative Research Institute - Port CharlottePort Charlotte, United StatesContact: Joseph Ravid (principal investigator)Taking people
  • Brown University School of Public HealthProvidence, United StatesContact: Carolina Haass-Koffler (principal investigator)Taking people
  • SKY Integrative Medical Center/SKYCRNGRidgeland, United StatesContact: Bob Hutchins (principal investigator)Taking people
  • Carilion ClinicRoanoke, United StatesContact: Albert Arias (principal investigator)Taking people
  • Maryland Treatment Centers - Avery Road Treatment CenterRockville, United StatesContact: Marc Fishman (principal investigator)Taking people
  • New Dimension GroupRose Hill, United StatesContact: Constance Olatidoye (principal investigator)Not yet recruiting
  • Center on Substance Use and Health (CSUH)San Francisco, United StatesContact: Phillip Coffin (principal investigator)Taking people
  • UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission BaySan Francisco, United StatesContact: Khaled Moussawi (principal investigator)Taking people
  • University of Washington - Harborview Medical CenterSeattle, United StatesContact: Elenore Bhatraju (principal investigator)Taking people
  • Avera Research Institute - Sioux FallsSioux Falls, United StatesContact: Vivek Anand (principal investigator)Taking people
  • Accelerated Clinical TrialsSnellville, United StatesContact: Darrell Murray (principal investigator)Not yet recruiting
  • Voltaire SpringfieldSpringfield, United StatesContact: Susan Smiga (principal investigator)Not yet recruiting
  • Better Years Ahead Medical CenterTampa, United StatesContact: Ana Suarez (principal investigator)Taking people
  • Adams Clinical BronxThe Bronx, United StatesContact: Shama Farooq (principal investigator)Taking people
  • Adams Clinical WatertownWatertown, United StatesContact: Daniel Rutrick (principal investigator)Taking people
  • Health Synergy Clinical ResearchWest Palm Beach, United StatesContact: Mohammad Nisar (principal investigator)Not yet recruiting
  • Neuroscience Research Institute - West Palm BeachWest Palm Beach, United StatesContact: Danesh Alam (principal investigator)Taking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 4 groups in the trial

  • Part A and Part B: Brenipatide + Buprenorphine Dose 1Treatment being tested

    Part A: Brenipatide administered subcutaneously (SC) + Buprenorphine administered sublingual or buccal. Part B: Open-label Treatment: Participants will receive Brenipatide SC + Buprenorphine sublingual or buccal.

    Treatment: Brenipatide and Buprenorphine

  • Part A: Brenipatide + Buprenorphine Dose 2Treatment being tested

    Brenipatide administered SC + Buprenorphine administered sublingual or buccal.

    Treatment: Brenipatide and Buprenorphine

  • Part A: Brenipatide + Buprenorphine Dose 3Treatment being tested

    Brenipatide administered SC + Buprenorphine administered sublingual or buccal.

    Treatment: Brenipatide and Buprenorphine

  • Part A: Placebo + BuprenorphinePlacebo, for comparison

    Placebo administered SC + Buprenorphine administered sublingual or buccal.

    Treatment: Placebo and Buprenorphine

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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)
Fit questions
Built from NCT07420283, who can take part
Record updated
4 November 2026