A Study of Brenipatide in Participants With Opioid Use Disorder
RENEW-Op-1
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)
2 other identifiers
interventional
465
4 countries
57
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2026
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2026
CompletedStudy Start
First participant enrolled
February 13, 2026
CompletedFirst Posted
Study publicly available on registry
February 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
May 22, 2026
May 1, 2026
2 years
February 11, 2026
May 20, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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 TLFB
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)
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
Week 13 up to Week 24
Occurrence of Opioid Overdose(s) (Nonfatal or Fatal)
Week 1 up to Week 24
Change in Buprenorphine Dose From Baseline
Baseline, Week 24
Change from Baseline in Modified Penn Craving Scale (PCS)
Baseline, Week 24
- +9 more secondary outcomes
Study Arms (4)
Part A and Part B: Brenipatide + Buprenorphine Dose 1
EXPERIMENTALPart A: Brenipatide administered subcutaneously (SC) + Buprenorphine administered sublingual or buccal. Part B: Open-label Treatment: Participants will receive Brenipatide SC + Buprenorphine sublingual or buccal.
Part A: Brenipatide + Buprenorphine Dose 2
EXPERIMENTALBrenipatide administered SC + Buprenorphine administered sublingual or buccal.
Part A: Brenipatide + Buprenorphine Dose 3
EXPERIMENTALBrenipatide administered SC + Buprenorphine administered sublingual or buccal.
Part A: Placebo + Buprenorphine
PLACEBO COMPARATORPlacebo administered SC + Buprenorphine administered sublingual or buccal.
Interventions
Administered SC
Administered sublingual or buccal
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
NoesisPharma - Phoenix - East Shea Boulevard
Phoenix, Arizona, 85028, United States
Pillar Clinical Research- Little Rock
Little Rock, Arkansas, 72204, United States
Woodland International Research Group
Little Rock, Arkansas, 72211, United States
Ark Clinical Research - Fountain Valley
Fountain Valley, California, 92708, United States
Center on Substance Use and Health (CSUH)
San Francisco, California, 94102, United States
UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
San Francisco, California, 94158, United States
Bradenton Research Center, Inc.
Bradenton, Florida, 34205, United States
K2 Medical Research - Daytona Beach
Daytona Beach, Florida, 32114, United States
NextPhase Research Florida - Hollywood
Hollywood, Florida, 33024, United States
Accel Research Sites - Lakeland Clinical Research Unit
Lakeland, Florida, 33803, United States
Life Arc Research Centers - Miami
Miami, Florida, 33126, United States
Advanced Research for Health Improvement, LLC
Naples, Florida, 34102, United States
Innovative Research Institute - Port Charlotte
Port Charlotte, Florida, 33952, United States
Better Years Ahead Medical Center
Tampa, Florida, 33614, United States
Neuroscience Research Institute - West Palm Beach
West Palm Beach, Florida, 33407, United States
Re:Cognition Health - Chicago
Chicago, Illinois, 60611, United States
Indiana University Health Neuroscience Center
Indianapolis, Indiana, 46202, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40508, United States
Maryland Treatment Centers - Mountain Manor Treatment Center
Baltimore, Maryland, 21229, United States
Maryland Treatment Centers - Avery Road Treatment Center
Rockville, Maryland, 20853, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Adams Clinical Boston
Boston, Massachusetts, 02116, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Adams Clinical Watertown
Watertown, Massachusetts, 02472, United States
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, 39157, United States
Adams Clinical Harlem
New York, New York, 10029, United States
Adams Clinical Bronx
The Bronx, New York, 10461, United States
Ohio Clinical Trials
Columbus, Ohio, 43212, United States
Rivus Wellness and Research Institute
Oklahoma City, Oklahoma, 73112, United States
Adams Clinical Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
Brown University School of Public Health
Providence, Rhode Island, 02903, United States
Avera Research Institute - Sioux Falls
Sioux Falls, South Dakota, 57108, United States
Adams Clinical Dallas
DeSoto, Texas, 75115, United States
Biopharma Informatic, LLC
Houston, Texas, 77043, United States
University of Virginia Health System
Charlottesville, Virginia, 22903, United States
Carilion Clinic
Roanoke, Virginia, 24014, United States
University of Washington - Harborview Medical Center
Seattle, Washington, 98104, United States
CaRe Clinic
Calgary, T2N 4L7, Canada
Med Trust Research
Courtice, L1E 2J5, Canada
Kelowna Health and Memory Centre
Kelowna, V1Y 5A8, Canada
Providence Care
Kingston, K7L 4X3, Canada
Malton Medical Group
Mississauga, L4T 4J2, Canada
Comprehensive Treatment Clinic
Toronto, M4J 1M3, Canada
Centre for Addiction and Mental Health (CAMH)
Toronto, M6J 1H4, Canada
Gordon and Leslie Diamond Health Care Centre
Vancouver, V5Z 1M9, Canada
Research Works San Juan
Guaynabo, 00966, Puerto Rico
Surrey and Borders Partnership NHS Foundation Trust
Chertsey, KT16 9AU, United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
St Pancras Clinical Research
London, EC2Y 8EA, United Kingdom
Bioluminux - London
London, SE6 4LF, United Kingdom
Lambeth Drug and Alcohol Treatment Consortium
London, SW9 8DG, United Kingdom
Bioluminux Clinical Research - Milton Keynes
Milton Keynes, MK15 0DU, United Kingdom
Salford Royal Hospital
Salford, M6 8HD, United Kingdom
Bioluminux - Southampton
Southampton, SO15 2AQ, United Kingdom
Old Bank House Hillingdon Drug & Alcohol
Uxbridge, UB8 1JP, United Kingdom
Bioluminux - Wolverhampton
Wolverhampton, WV9 5HB, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2026
First Posted
February 19, 2026
Study Start
February 13, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2028
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
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.