A Study of Brenipatide in Participants With Opioid Use Disorder

NCT07420283
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
465
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
clinicaltrials.gov
Start date
2026-02-13
clinicaltrials.gov
Number of sites
58
clinicaltrials.gov

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.
clinicaltrials.gov
Acronym
RENEW-Op-1
clinicaltrials.gov
Short title
A Study of Brenipatide in Participants With Opioid Use Disorder
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)
clinicaltrials.gov

Control arm
Placebo
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2028-03-01
clinicaltrials.gov
First posted
2026-02-19
clinicaltrials.gov
Registry last updated
2026-08-21
clinicaltrials.gov
Primary completion date
2028-03-01
clinicaltrials.gov
Start date
2026-02-13
clinicaltrials.gov

Participants
465
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
465
clinicaltrials.gov
Protocol amendments
0
clinicaltrials.gov
Number of sites
58
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07420283
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07420283
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. 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)

    Timeframe: Week 13 up to Week 24

  2. Achievement of ≥80% Weeks of Abstinence from Opioid Use Defined by Both Negative UDS and no Self-Report of Opioid Use Based on TLFB

    Timeframe: Week 13 up to Week 24

  1. 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)

    Timeframe: Week 13 up to Week 24

  2. Achievement of 100% Weeks of Abstinence from Opioid Use Defined by Both Negative UDS and no Self-Report of Opioid Use Based on TLFB

    Timeframe: Week 13 up to Week 24

  3. Occurrence of Opioid Overdose(s) (Nonfatal or Fatal)

    Timeframe: Week 1 up to Week 24

  4. Change in Buprenorphine Dose From Baseline

    Timeframe: Baseline, Week 24

  5. Change from Baseline in Modified Penn Craving Scale (PCS)

    Timeframe: Baseline, Week 24

  6. Change from Baseline on Incidence of Healthcare Provider Visits Using Lilly-developed Health Care Resource Utilization (HCRU) scale

    Timeframe: Baseline, Week 24

  7. Change from Baseline on Work and Social Adjustment Scale (WSAS)

    Timeframe: Baseline, Week 24

  8. 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)

    Timeframe: Baseline, Week 24

  9. Change from Baseline on Quality of Life Outcome on Short Inventory of Problems - Revised (SIP-R)

    Timeframe: Baseline, Week 24

  10. Change from Baseline in Body Weight

    Timeframe: Baseline, Week 24

  11. Change from Baseline in Body Mass Index (BMI)

    Timeframe: Baseline, Week 24

  12. Change from Baseline in Blood Pressure

    Timeframe: Baseline, Week 24

  13. Pharmacokinetics (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide

    Timeframe: Baseline up to Week 24

  14. Number of Participants with Treatment-Emergent Anti-drug Antibodies

    Timeframe: Baseline up to Week 24

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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

  • 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

Sources for eligibility
clinicaltrials.gov

  • NoesisPharma - Phoenix - East Shea BoulevardPhoenix, United StatesRecruiting
  • Pillar Clinical Research- Little RockLittle Rock, United StatesRecruiting
  • Woodland International Research GroupLittle Rock, United StatesRecruiting
  • Ark Clinical Research - Fountain ValleyFountain Valley, United StatesRecruiting
  • Center on Substance Use and Health (CSUH)San Francisco, United StatesRecruiting
  • UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission BaySan Francisco, United StatesRecruiting
  • Bradenton Research Center, Inc.Bradenton, United StatesRecruiting
  • K2 Medical Research - Daytona BeachDaytona Beach, United StatesRecruiting
  • NextPhase Research Florida - HollywoodHollywood, United StatesRecruiting
  • Accel Research Sites - Lakeland Clinical Research UnitLakeland, United StatesRecruiting
  • Life Arc Research Centers - MiamiMiami, United StatesRecruiting
  • Advanced Research for Health Improvement, LLCNaples, United StatesRecruiting
  • Innovative Research Institute - Port CharlottePort Charlotte, United StatesRecruiting
  • Better Years Ahead Medical CenterTampa, United StatesRecruiting
  • Neuroscience Research Institute - West Palm BeachWest Palm Beach, United StatesRecruiting
  • Re:Cognition Health - ChicagoChicago, United StatesRecruiting
  • Indiana University Health Neuroscience CenterIndianapolis, United StatesRecruiting
  • University of Kentucky Chandler Medical CenterLexington, United StatesRecruiting
  • Maryland Treatment Centers - Mountain Manor Treatment CenterBaltimore, United StatesRecruiting
  • Maryland Treatment Centers - Avery Road Treatment CenterRockville, United StatesRecruiting
  • Brigham and Women's HospitalBoston, United StatesRecruiting
  • Adams Clinical BostonBoston, United StatesRecruiting
  • Boston Medical CenterBoston, United StatesNot yet recruiting
  • Adams Clinical WatertownWatertown, United StatesRecruiting
  • SKY Integrative Medical Center/SKYCRNGRidgeland, United StatesRecruiting

And 33 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • J2S-MC-GZMG
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Targets (2)