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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
465
Administered SC
Administered SC
Administered sublingual or buccal
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)
Time frame: 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
Time frame: Week 13 up to Week 24
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)
Time frame: 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
Time frame: Week 13 up to Week 24
Occurrence of Opioid Overdose(s) (Nonfatal or Fatal)
Time frame: Week 1 up to Week 24
Change in Buprenorphine Dose From Baseline
Time frame: Baseline, Week 24
Change from Baseline in Modified Penn Craving Scale (PCS)
Time frame: Baseline, Week 24
Change from Baseline on Incidence of Healthcare Provider Visits Using Lilly-developed Health Care Resource Utilization (HCRU) scale
Time frame: Baseline, Week 24
Change from Baseline on Work and Social Adjustment Scale (WSAS)
Time frame: Baseline, Week 24
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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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)
Time frame: Baseline, Week 24
Change from Baseline on Quality of Life Outcome on Short Inventory of Problems - Revised (SIP-R)
Time frame: Baseline, Week 24
Change from Baseline in Body Weight
Time frame: Baseline, Week 24
Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 24
Change from Baseline in Blood Pressure
Time frame: Baseline, Week 24
Pharmacokinetics (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Time frame: Baseline up to Week 24
Number of Participants with Treatment-Emergent Anti-drug Antibodies
Time frame: Baseline up to Week 24