A Study of Brenipatide in Adult Participants With Schizophrenia

Официальное название

A Phase 2 Multicenter, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Adult Participants With Schizophrenia (RENEW-Scz-1)

Обзор

The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC for treatment of schizophrenia. The trial is divided into three periods as follows: Screening period will last approximately 1 month, treatment period will last a maximum of 12 months, and the follow up period will last approximately 2 months. The length of time of your study participation may last up to approximately 15 months.

Вмешательства

• Препарат Brenipatide
  Administered SC
• Препарат Placebo
  Administered SC

Первичные конечные точки

• Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index ≥25.0 Kilograms per Meter Squared (kg/m²) [Срок оценки: Baseline, Week 52]

Вторичные конечные точки (10)

• Change from Baseline on Neurocognitive Battery Composite Test Score at Week 36 [Срок оценки: Baseline, Week 36]
• Time to Relapse [Срок оценки: Randomization up to Week 52]
• Change from Baseline in Clinical Global Impression - Severity - Schizophrenia (CGI-S-SCH) [Срок оценки: Baseline, Week 52]
• Change from Baseline in Patient Global Impression - Severity [Срок оценки: Baseline, Week 52]
• Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score [Срок оценки: Baseline, Week 52]
• Change from Baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) Total Completion Time [Срок оценки: Baseline, Week 52]
• Change from Baseline on the Schizophrenia Cognition Rating Scale (SCoRS) Total Score [Срок оценки: Baseline, Week 52]
• Percentage of Participants with Body Mass Index ≥25 kg/m2 (BMI) Who Achieve Body Weight Reduction of ≥5% [Срок оценки: Baseline up to 52 Weeks]
• Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide [Срок оценки: Baseline up to Week 52]
• Number of Participants with Treatment-Emergent Anti-Drug Antibodies [Срок оценки: Baseline up to Week 52]

Критерии участия

Критерии включения

• Meet the diagnostic criteria of schizophrenia
• Are on a stable standard of care medication regimen for schizophrenia
• If the duration of illness is >6 years, participant has experienced at least one relapse of schizophrenia in last 3 years
• Have at least 1 reliable study partner (for example, a family member, social worker, caseworker, residential facility staff, or nurse)
• 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 store and use the provided study intervention as directed,
• maintain electronic or paper study diaries, as applicable, and
• complete the required questionnaires

Критерии исключения

• Have lifetime history of bipolar disorder, borderline personality disorder, or any eating disorder
• Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening
• Have type 1 diabetes, or history of ketoacidosis or hyperosmolar state or coma
• Are actively suicidal or deemed to be a significant risk for suicide
• Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study

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 · 32 центра

• Pillar Clinical Research- Little Rock — Little Rock
• Clinical Innovations, Inc. dba CITrials — Bellflower
• Collaborative Neuroscience Research, LLC — Garden Grove
• Catalina Research Institute, LLC — Montclair
• Stanford University School of Medicine — Stanford
• Collaborative Neuroscience Research, LLC — Torrance
• Sunwise Clinical Research — Walnut Creek
• Institute of Living — Hartford
• … и ещё 24 центра

Япония · 16 центров

• Uematsu Mental Clinic — Chikugo
• Horikoshi Mental Somatic Clinic — Fukushima
• Seinan Hospital — Hachinohe
• … и ещё 13 центров

Аргентина · 13 центров

• Centro Neurobiológico y de Estrés Traumático (CENydET) — Buenos Aires
• Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM) — Buenos Aires
• Instituto Nacional de Psicopatología (INAPsi)- FunDaMos — Buenos Aires
• Centro de Investigaciones Metabólicas (CINME) — Buenos Aires
• CEN Centro Especializado en Neurociencias — Córdoba
• Sanatorio Morra S.A. — Córdoba
• Instituto Kremer — Córdoba
• Centro Médico Luquez — Córdoba
• … и ещё 5 центров

Индия · 13 центров

• Galaxy Superspeciality Hospital — Aurangabad
• All India Institute of Medical Sciences (AIIMS) - Bhopal — Bhopal
• Rajiv Gandhi Government General Hospital — Chennai
• Graphic Era Institute of Medical Sciences and Hospital — Dehradun
• Dharwad Institute Of Mental Health And Neurosciences — Dharwad
• Calida Rehab - Karjat — Karjat
• Shree Mahalaxmi DIATONE Institute — Kolhāpur
• Dr. Ram Manohar Lohia Institute of Medical Sciences — Lucknow
• … и ещё 5 центров

Бразилия · 11 центров

• Hospital das Clínicas da UFMG — Belo Horizonte
• Chronos Pesquisa Clínica — Brasília
• Instituto de Pesquisa clinica de Campinas — Campinas
• Trial Tech — Curitiba
• Clinilive — Maringá
• Instituto Atena de Pesquisa Clinica — Natal
• Ruschel Medicina e Pesquisa Clínica — Rio de Janeiro
• Instituto Apice — Salvador
• … и ещё 3 центра

Тайвань · 10 центров

Список центров уточняется — проверьте первичный протокол.

Китай · 8 центров

• The Second Xiangya Hospital of Central South University — Чанша
• The Fourth People's Hospital of Chengdu — Чэнду
• The Seventh People's Hospital of Hangzhou — Ханчжоу
• Suzhou Guangji Hospital — Сучжоу
• Tianjin Anding Hospital — Тяньцзинь
• Wuhu Hospital of Beijing Anding hospital — Wuhu
• Xi An Mental Health Center — Сиань
• Zhumadian Psychiatric Hospital — Zhumadian

Идентификаторы

NCT: NCT07410507 · 27366 · J2S-MC-GZMK

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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