A Study of Brenipatide in Participants With Opioid Use Disorder

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Brenipatide
  Administered SC
• Препарат Placebo
  Administered SC
• Препарат Buprenorphine
  Administered sublingual or buccal

Первичные конечные точки

• 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) [Срок оценки: 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 [Срок оценки: Week 13 up to Week 24]

Вторичные конечные точки (12)

• 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) [Срок оценки: 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 [Срок оценки: Week 13 up to Week 24]
• Occurrence of Opioid Overdose(s) (Nonfatal or Fatal) [Срок оценки: Week 1 up to Week 24]
• Change in Buprenorphine Dose From Baseline [Срок оценки: Baseline, Week 24]
• Change from Baseline in Modified Penn Craving Scale (PCS) [Срок оценки: Baseline, Week 24]
• Change from Baseline on Incidence of Healthcare Provider Visits Using Lilly-developed Health Care Resource Utilization (HCRU) scale [Срок оценки: Baseline, Week 24]
• Change from Baseline on Work and Social Adjustment Scale (WSAS) [Срок оценки: 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) [Срок оценки: Baseline, Week 24]
• Change from Baseline on Quality of Life Outcome on Short Inventory of Problems - Revised (SIP-R) [Срок оценки: Baseline, Week 24]
• Change from Baseline in Body Weight [Срок оценки: Baseline, Week 24]
• Change from Baseline in Body Mass Index (BMI) [Срок оценки: Baseline, Week 24]
• Change from Baseline in Blood Pressure [Срок оценки: Baseline, Week 24]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 38 центров

• NoesisPharma - Phoenix - East Shea Boulevard — Phoenix
• Pillar Clinical Research- Little Rock — Little Rock
• Woodland International Research Group — Little Rock
• Ark Clinical Research - Fountain Valley — Fountain Valley
• Center on Substance Use and Health (CSUH) — San Francisco
• UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay — San Francisco
• Bradenton Research Center, Inc. — Bradenton
• K2 Medical Research - Daytona Beach — Daytona Beach
• … и ещё 30 центров

Великобритания · 11 центров

• Surrey and Borders Partnership NHS Foundation Trust — Chertsey
• St Pancras Clinical Research - Eastbourne — Eastbourne
• Queen Elizabeth University Hospital — Glasgow
• St Pancras Clinical Research — London
• Bioluminux - London — London
• Lambeth Drug and Alcohol Treatment Consortium — London
• Greater Manchester Mental Health NHS Foundation Trust — Manchester
• Bioluminux Clinical Research - Milton Keynes — Milton Keynes
• … и ещё 3 центра

Канада · 8 центров

• CaRe Clinic — Calgary
• Med Trust Research — Courtice
• The Medical Arts Health Research Group — Kamloops
• Kelowna Health and Memory Centre — Kelowna
• Providence Care — Kingston
• Malton Medical Group — Mississauga
• Comprehensive Treatment Clinic — Toronto
• Centre for Addiction and Mental Health (CAMH) — Toronto

Пуэрто-Рико · 1 центр

• Research Works San Juan — Guaynabo

Идентификаторы

NCT: NCT07420283 · 27348 · J2S-MC-GZMG

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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