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RENEW-Op-1NCT07420283

A Study of Brenipatide in Participants With Opioid Use Disorder

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 16 versions: 16 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 59 → 68 locations
  2. Study sites: 59 to 61
  3. Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 1 of 14 entries
    • Site details revised at 5 of 59 sites
    • Study description expanded, about 2 words
  4. Study sites: 58 to 59v13
  5. Site details revised at 1 of 58 sitesv12
Show 7 earlier versionsHide 7 earlier versions
  1. Site details revised at 3 of 58 sitesv11
  2. Study sites: 59 to 58v10
  3. Study sites: 57 to 59v9
  4. Site details revised at 4 of 57 sitesv8
  5. Site details revised at 2 of 57 sitesv7
  6. Site details revised at 6 of 57 sitesv6
  7. Site details revised at 12 of 57 sitesv5
  1. Primary completion pushed from Aug 2027 to Mar 2028
    • Study completion date: Feb 2028 to Mar 2028
    • Start date: Mar 12, 2026 to Feb 13, 2026
    v4
  2. Study sites: 56 to 57
    • Start date: Feb 13, 2026 to Mar 12, 2026
    v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 53 to 56
    • Primary completion date: Mar 2028 to Aug 2027
    • Study completion date: Mar 2028 to Feb 2028
    • Start date changed from estimate of Feb 2026 to Feb 13, 2026
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

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
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

Secondary (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)
Achievement of 100% Weeks of Abstinence from Opioid Use Defined by Both Negative UDS and no Self-Report of Opioid Use Based on TLFB
Occurrence of Opioid Overdose(s) (Nonfatal or Fatal)
Change in Buprenorphine Dose From Baseline
Change from Baseline in Modified Penn Craving Scale (PCS)
Show 9 moreShow less
Change from Baseline on Incidence of Healthcare Provider Visits Using Lilly-developed Health Care Resource Utilization (HCRU) scale
Change from Baseline on Work and Social Adjustment Scale (WSAS)
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)
Change from Baseline on Quality of Life Outcome on Short Inventory of Problems - Revised (SIP-R)
Change from Baseline in Body Weight
Change from Baseline in Body Mass Index (BMI)
Change from Baseline in Blood Pressure
Pharmacokinetics (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Number of Participants with Treatment-Emergent Anti-drug Antibodies

Arms and interventions

Part A and Part B: Brenipatide + Buprenorphine Dose 1Experimental

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.

Part A: Brenipatide + Buprenorphine Dose 2Experimental

Brenipatide administered SC + Buprenorphine administered sublingual or buccal.

Part A: Brenipatide + Buprenorphine Dose 3Experimental

Brenipatide administered SC + Buprenorphine administered sublingual or buccal.

Part A: Placebo + BuprenorphinePlacebo comparator

Placebo administered SC + Buprenorphine administered sublingual or buccal.

Drugs: Brenipatide, Placebo, Buprenorphine

Sites

68 sites in 4 countries

United States 46, United Kingdom 12, Canada 9, Puerto Rico 1