A Study of Brenipatide in Participants With Alcohol Use Disorder

Официальное название

A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Alcohol Use Disorder (RENEW-ALC-2)

Обзор

The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with Alcohol Use Disorder (AUD) and hazardous alcohol use. Participation in this study will last approximately 56 weeks.

Вмешательства

• Препарат LY3537031
  Administered SC
• Препарат Placebo
  Administered SC

Первичные конечные точки

• Change in Drinking Patterns in Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB) [Срок оценки: Up to 56 weeks]

Вторичные конечные точки (7)

• Change in Daily Alcohol Consumption as Assessed by the TLFB [Срок оценки: Up to 56 weeks]
• Mean Change in Alcohol Craving as Assessed by the Penn Alcohol Craving Scale (PACS) [Срок оценки: Baseline up to Week 56]
• Mean Change in Alcohol Use Disorders Identification Test (AUDIT) Score [Срок оценки: Baseline up to Week 56]
• Mean Change in Body Weight [Срок оценки: Baseline up to Week 56]
• Mean Change in Patient Reported Health Outcomes as Measured by Short Form 36, v2 (SF-36) Acute Form Domain and Component Summary Scores [Срок оценки: Baseline up to Week 56]
• Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide [Срок оценки: Baseline up to Week 56]
• Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADA) [Срок оценки: Baseline up to Week 56]

Критерии участия

Критерии включения

• Participant must be a minimum of 20 years of age for the investigative sites in Japan.
• Are seeking treatment and are motivated to stop or cut down on drinking.
• Are reliable and willing to make themselves available for the duration of the study 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 receive assistance from a support person trained to administer the study intervention.
• store and use the provided blinded study intervention, as directed
• maintain electronic and paper study diaries, as applicable, and
• complete the required questionnaires.

Критерии исключения

• Have evidence of current or within the past 180 days prior to screening (V1), history of any substance use disorder(s) of any severity with a pattern of persistent illicit or nonprescribed substance use as indicated by clinical interview, except alcohol, nicotine, or caffeine.
• Have answered "yes" to either Question 4 or Question 5 on the "Suicidal Ideation" portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) and the ideation occurred within the past 6 months, or Have answered "yes" to any of the suicide-related behaviors on the "Suicidal Behavior" portion of the C-SSRS and the behavior occurred within the past 6 months
• Have either of the following:

• history of advanced liver disease, including advanced liver fibrosis \[Stage 3\] or cirrhosis \[Stage 4\], based on prior biomarkers, imaging or liver biopsy, OR
• history of acute or alcohol-associated hepatitis based on prior liver biopsy.
• Have participated in a clinical study and have received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening (V1).

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 · 29 центров

• Headlands Research - Scottsdale — Scottsdale
• Woodland International Research Group — Little Rock
• UCLA Clinical & Translational Research Center (CTRC) — Los Angeles
• Artemis Institute for Clinical Research — Riverside
• Artemis Institute for Clinical Research — San Diego
• UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay — San Francisco
• Accel Research Sites - Lakeland Clinical Research Unit — Lakeland
• Innovative Clinical Research — Lauderhill
• … и ещё 21 центр

Китай · 27 центров

• Beijing Anding Hospital - Affiliated Capital University of Medical Science — Пекин
• Beijing HuiLongGuan Hospital — Пекин
• The Second People's Hospital of Hunan Province — Чанша
• The Second Xiangya Hospital of Central South University — Чанша
• West China Hospital, Sichuan University — Cheng Du Shi
• The Fourth People's Hospital of Chengdu — Чэнду
• Guangzhou Brain Hospital — Гуанчжоу
• The Seventh People's Hospital of Hangzhou — Ханчжоу
• … и ещё 19 центров

Япония · 16 центров

• Tokyo-Eki Center-building Clinic — Chūōku
• Ai Sakura Clinic — Fukuoka
• Hiro Mental Clinic — Fukuoka
• Rainbow and Sea Hospital — Karatsu
• Tatsuta Clinic — Kobe
• Arata Clinic — Nagasaki
• Yokogawa Ekimae Clinic — Nishi
• Hillside Clinic Jingumae — Shibuya City
• … и ещё 8 центров

South Korea · 15 центров

Список центров уточняется — проверьте первичный протокол.

Великобритания · 11 центров

Список центров уточняется — проверьте первичный протокол.

Германия · 7 центров

• FutureMeds GmbH — Berlin
• Velocity Clinical Research, Berlin — Berlin
• Klinische Forschung Dresden — Dresden
• Klinische Forschung Hamburg — Hamburg
• Zentralinstitut für Seelische Gesundheit — Mannheim
• Dedicated Research Site FutureMeds — Offenbach
• Klinische forschung Schwerin GmbH — Schwerin

Тайвань · 6 центров

Список центров уточняется — проверьте первичный протокол.

Бельгия · 5 центров

• ANIMA Research — Diepenbeek
• Kormont — Kluisbergen
• Gezondheidshuis De Gloed — Machelen
• Meclinas — Mechelen
• Medisch Centrum Saffrou — Oudenaarde

Идентификаторы

NCT: NCT07219953 · 27410 · 2025-522312-16-00 · J2S-MC-GZMP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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