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)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 465
- 试验地点
- 67
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Part A and Part B: Brenipatide + Buprenorphine Dose 1
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.
干预措施: Brenipatide (Drug)
Part A: Brenipatide + Buprenorphine Dose 2
Brenipatide administered SC + Buprenorphine administered sublingual or buccal.
干预措施: Brenipatide (Drug)
Part A: Brenipatide + Buprenorphine Dose 3
Brenipatide administered SC + Buprenorphine administered sublingual or buccal.
干预措施: Brenipatide (Drug)
Part A: Placebo + Buprenorphine
Placebo administered SC + Buprenorphine administered sublingual or buccal.
干预措施: Placebo (Drug)
Part A: Brenipatide + Buprenorphine Dose 2
Brenipatide administered SC + Buprenorphine administered sublingual or buccal.
干预措施: Buprenorphine (Drug)
Part A: Brenipatide + Buprenorphine Dose 3
Brenipatide administered SC + Buprenorphine administered sublingual or buccal.
干预措施: Buprenorphine (Drug)
Part A and Part B: Brenipatide + Buprenorphine Dose 1
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.
干预措施: Buprenorphine (Drug)
Part A: Placebo + Buprenorphine
Placebo administered SC + Buprenorphine administered sublingual or buccal.
干预措施: Buprenorphine (Drug)
结局指标
主要结局
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)
时间窗: 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
时间窗: Week 13 up to Week 24
次要结局
- Change from Baseline on Work and Social Adjustment Scale (WSAS)(Baseline, Week 24)
- Change from Baseline in Body Weight(Baseline, Week 24)
- Change from Baseline in Body Mass Index (BMI)(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)(Baseline, Week 24)
- Change from Baseline on Quality of Life Outcome on Short Inventory of Problems - Revised (SIP-R)(Baseline, Week 24)
- Change from Baseline in Blood Pressure(Baseline, Week 24)
- Pharmacokinetics (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide(Baseline up to Week 24)
- Number of Participants with Treatment-Emergent Anti-drug Antibodies(Baseline up to Week 24)
- Change from Baseline in Modified Penn Craving Scale (PCS)(Baseline, Week 24)
- Change from Baseline on Incidence of Healthcare Provider Visits Using Lilly-developed Health Care Resource Utilization (HCRU) scale(Baseline, 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)(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)