Opioid Use DisorderPhase 2RENEW-Op-1NCT07420283
A Study of Brenipatide in Participants With Opioid Use Disorder
A Phase 2 study testing Brenipatide and Buprenorphine in people with Opioid Use Disorder, run by Eli Lilly and Company at 61 sites in 4 countries.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Brenipatide and Buprenorphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 465 participants
- Where
- 61 sitesin 4 countries
- Study dates
- 13 Feb 2026to Mar 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
61 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
61 sites in 4 countries
United States40 sites, 40 recruiting
- Recruiting
Maryland Treatment Centers - Mountain Manor Treatment Center
Baltimore, Maryland, 21229
Marc Fishman
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Joji Suzuki
- Recruiting
Adams Clinical Boston
Boston, Massachusetts, 02116
Darin Dougherty
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Alyssa Peterkin
- Recruiting
Bradenton Research Center, Inc.
Bradenton, Florida, 34205
941-708-0005
Eric Folkens
- Not yet recruiting
University of Virginia Health System
Charlottesville, Virginia, 22903
434-243-0563
Nassima Ait-Daoud Tiouririne
- Recruiting
Re:Cognition Health - Chicago
Chicago, Illinois, 60611
Abid Nazeer
- Recruiting
Ohio Clinical Trials
Columbus, Ohio, 43212
380-210-2424
Angela Eakin
- Recruiting
K2 Medical Research - Daytona Beach
Daytona Beach, Florida, 32114
Esteban Olivera
- Recruiting
Adams Clinical Dallas
DeSoto, Texas, 75115
Benji Kurian
- Recruiting
Ark Clinical Research - Fountain Valley
Fountain Valley, California, 92708
714-988-2021
Justin Yanuck
- Recruiting
NextPhase Research Florida - Hollywood
Hollywood, Florida, 33024
Peter Ventre
- Recruiting
Biopharma Informatic, LLC
Houston, Texas, 77043
281-944-3610
James Lai, MD
- Recruiting
Indiana University Health Neuroscience Center
Indianapolis, Indiana, 46202
Michael Bushey
- Recruiting
Accel Research Sites - Lakeland Clinical Research Unit
Lakeland, Florida, 33803
863-940-2087
James Andersen
- Recruiting
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40508
Shanna Babalonis
- Recruiting
Pillar Clinical Research- Little Rock
Little Rock, Arkansas, 72204
Leslie Smith
- Recruiting
Woodland International Research Group
Little Rock, Arkansas, 72211
501-221-8681
George Konis
- Recruiting
Life Arc Research Centers - Miami
Miami, Florida, 33126
305-874-7401
Janny Rivera
- Not yet recruiting
Wellness Research Center
Miami, Florida, 33135
305-300-2623
Emilio Mantero-Atienza
- Recruiting
Advanced Research for Health Improvement, LLC
Naples, Florida, 34102
239-230-2021
Leonard Lado
- Recruiting
Adams Clinical Harlem
New York, New York, 10029
917-423-67697
Rachel Noone
- Not yet recruiting
Rivus Wellness and Research Institute
Oklahoma City, Oklahoma, 73112
405-753-4994
Marvin Peyton
- Recruiting
Adams Clinical Philadelphia
Philadelphia, Pennsylvania, 19104
Cassie Blanchard
- Recruiting
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
610-639-3592
Kyle Kampman
- Recruiting
NoesisPharma - Phoenix - East Shea Boulevard
Phoenix, Arizona, 85028
John Prater
- Recruiting
Innovative Research Institute - Port Charlotte
Port Charlotte, Florida, 33952
941-505-2100
Joseph Ravid
- Recruiting
Brown University School of Public Health
Providence, Rhode Island, 02903
Carolina Haass-Koffler
- Recruiting
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, 39157
601-567-1321
Bob Hutchins
- Recruiting
Carilion Clinic
Roanoke, Virginia, 24014
540-981-8025
Albert Arias
- Recruiting
Maryland Treatment Centers - Avery Road Treatment Center
Rockville, Maryland, 20853
Marc Fishman
- Recruiting
Center on Substance Use and Health (CSUH)
San Francisco, California, 94102
Phillip Coffin
- Recruiting
UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
San Francisco, California, 94158
Khaled Moussawi
- Recruiting
University of Washington - Harborview Medical Center
Seattle, Washington, 98104
Elenore Bhatraju
- Recruiting
Avera Research Institute - Sioux Falls
Sioux Falls, South Dakota, 57108
605-504-3154
Vivek Anand
- Recruiting
Better Years Ahead Medical Center
Tampa, Florida, 33614
813-709-8299
Ana Suarez
- Recruiting
Adams Clinical Bronx
The Bronx, New York, 10461
Shama Farooq
- Recruiting
Adams Clinical Watertown
Watertown, Massachusetts, 02472
617-744-8542
Daniel Rutrick
- Not yet recruiting
Health Synergy Clinical Research
West Palm Beach, Florida, 33407
786-863-3325
Mohammad Nisar
- Recruiting
Neuroscience Research Institute - West Palm Beach
West Palm Beach, Florida, 33407
Danesh Alam
United Kingdom12 sites, 12 recruiting
- Recruiting
Surrey and Borders Partnership NHS Foundation Trust
Chertsey, KT16 9AU
CHRISTOS KOUIMTSIDIS
- Not yet recruiting
Clerkenwell Health - Doncaster
Doncaster, DN4 8QN
Ibreez Ajaz
- Recruiting
St Pancras Clinical Research - Eastbourne
Eastbourne, BN23 5UZ
020 3865 1142
Graham Campbell
- Recruiting
Queen Elizabeth University Hospital
Glasgow, G51 4TF
(+44) 0141 232 7600
Nagore Penades
- Recruiting
St Pancras Clinical Research
London, EC2Y 8EA
02038651142
Ward Lawrence
- Recruiting
Bioluminux - London
London, SE6 4LF
Laxmi Patel
- Not yet recruiting
Clerkenwell Health - London - Welbeck Street
London, W1G 8DR
Alishah Suleman
- Not yet recruiting
Greater Manchester Mental Health NHS Foundation Trust
Manchester, M25 3BL
Stephen Kaar
- Recruiting
Bioluminux Clinical Research - Milton Keynes
Milton Keynes, MK15 0DU
Kayode Timothy
- Recruiting
Bioluminux - Southampton
Southampton, SO15 2AQ
Adebayo Jejeloye
- Not yet recruiting
Old Bank House Hillingdon Drug & Alcohol
Uxbridge, UB8 1JP
Jeffrey Fehler
- Recruiting
Bioluminux - Wolverhampton
Wolverhampton, WV9 5HB
Joshua Olofinlade
Canada8 sites, 8 recruiting
- Recruiting
CaRe Clinic
Calgary, T2N 4L7
587-955-3401
Sumantra Ghosh
- Recruiting
Med Trust Research
Courtice, L1E 2J5
905-728-7915
Hamilton Jeyaraj
- Recruiting
The Medical Arts Health Research Group
Kamloops, V2C 1K7
Dustin Janz
- Recruiting
Kelowna Health and Memory Centre
Kelowna, V1Y 5A8
Eugene Okorie
- Recruiting
Providence Care
Kingston, K7L 4X3
6135444900
Roumen Milev
- Recruiting
Malton Medical Group
Mississauga, L4T 4J2
905-677-4200
Brian Zidel
- Recruiting
Comprehensive Treatment Clinic
Toronto, M4J 1M3
Leonard Bienenstock
- Recruiting
Centre for Addiction and Mental Health (CAMH)
Toronto, M6J 1H4
Bernard Le Foll
Puerto Rico1 site, 1 recruiting
- Recruiting
Research Works San Juan
Guaynabo, 00966
787-315-1669
Jose Feliberti
About this study
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)
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.
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.
Read the detailed description
The study consists of 2 parts, each with its own participant cohort
- Part A: double-blind treatment with open-label extension (OLE)
- Part B: open-label treatment.
Participants will be enrolled in only one part of the study.
- Conditions
- Opioid Use Disorder
- Being tested
- Brenipatide, Placebo, Buprenorphine
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrenipatideDrug
Also called LY3537031
Administered SC
PlaceboDrug
Administered SC
BuprenorphineDrug
Administered sublingual or buccal
| Study group | Role | What they receive |
|---|---|---|
| Part A and Part B: Brenipatide + Buprenorphine Dose 1 | Experimental | 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. Receives: Drug: Brenipatide; Drug: Buprenorphine |
| Part A: Brenipatide + Buprenorphine Dose 2 | Experimental | Brenipatide administered SC + Buprenorphine administered sublingual or buccal. Receives: Drug: Brenipatide; Drug: Buprenorphine |
| Part A: Brenipatide + Buprenorphine Dose 3 | Experimental | Brenipatide administered SC + Buprenorphine administered sublingual or buccal. Receives: Drug: Brenipatide; Drug: Buprenorphine |
| Part A: Placebo + Buprenorphine | Placebo comparator | Placebo administered SC + Buprenorphine administered sublingual or buccal. Receives: Drug: Placebo; Drug: Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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 TLFB
Measured: Week 13 up to Week 24
Secondary outcomes (14)
Gated Secondary Outcome: Adherence to Buprenorphine as Demonstrated by Self-Report Buprenorphine, with or Without Naloxone (BUP±NX) and not Contradicted by Negative UDS (BUP)
Measured: Week 13 up to Week 24
Achievement of 100% Weeks of Abstinence from Opioid Use Defined by Both Negative UDS and no Self-Report of Opioid Use Based on TLFB
Measured: Week 13 up to Week 24
Occurrence of Opioid Overdose(s) (Nonfatal or Fatal)
Measured: Week 1 up to Week 24
Change in Buprenorphine Dose From Baseline
Measured: Baseline, Week 24
Change from Baseline in Modified Penn Craving Scale (PCS)
Measured: Baseline, Week 24
Change from Baseline on Incidence of Healthcare Provider Visits Using Lilly-developed Health Care Resource Utilization (HCRU) scale
Measured: Baseline, Week 24
Change from Baseline on Work and Social Adjustment Scale (WSAS)
Measured: Baseline, Week 24
Achievement of >1 Level of Reduction of Diagnosis Severity Category or no Longer Have OUD Diagnosis per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
Measured: Baseline, Week 24
Change from Baseline on Quality of Life Outcome on Short Inventory of Problems - Revised (SIP-R)
Measured: Baseline, Week 24
Change from Baseline in Body Weight
Measured: Baseline, Week 24
Change from Baseline in Body Mass Index (BMI)
Measured: Baseline, Week 24
Change from Baseline in Blood Pressure
Measured: Baseline, Week 24
Pharmacokinetics (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Measured: Baseline up to Week 24
Number of Participants with Treatment-Emergent Anti-drug Antibodies
Measured: Baseline up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start13 Feb 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 465 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420283
- Sponsor's protocol ID
- 27348
- Other IDs
- J2S-MC-GZMG
- Acronym
- RENEW-Op-1
- Status last verified
- Oct 2026
- First submitted
- 11 Feb 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.