A Study of Brenipatide in Adult Participants With Major Depressive Disorder

Официальное название

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Major Depressive Disorder (RENEW-MDD 1)

Обзор

This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms. The trial is divided into three periods as follows: a screening period that will last approximately 1 month, a treatment period that will last a minimum of 12 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if depression symptoms worsen or if withdrawal from the study occurs for any reason.

Вмешательства

• Препарат Brenipatide
  Administered SC
• Препарат Placebo
  Administered SC

Первичные конечные точки

• Time to Relapse Defined as the Number of Days from Randomization to Date on Which the Participant Meets Any Relapse Criterion of Major Depressive Disorder (MDD) [Срок оценки: From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months]

Вторичные конечные точки (11)

• Mean Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m2 [Срок оценки: Baseline, Up to at Least 6 Months]
• Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score [Срок оценки: Baseline, Up to at Least 6 Months]
• Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score [Срок оценки: Baseline, Up to at Least 6 Months]
• Change from Baseline in Patient Global Impression of Severity (PGI-S) [Срок оценки: Baseline, Up to at Least 6 Months]
• Change from Baseline in Generalized Anxiety Disorder (GAD) - 7 Total Score [Срок оценки: Baseline, Up to at Least 6 Months]
• Change from Baseline in Patient Rated Symptom and Disease Severity [Срок оценки: Baseline, Up to at least 6 months]
• Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score [Срок оценки: Baseline, Up to at Least 6 Months]
• Mean Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m2 and on an Atypical Antipsychotic [Срок оценки: Baseline, Up to at Least 6 Months]
• Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide [Срок оценки: Predose Up to at Least 6 Months]
• Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADA) [Срок оценки: Baseline Up to at Least 6 Months]
• Change from Baseline in Patient-Reported Outcomes Measurement Information Systems (PROMIS) Short Form [Срок оценки: Baseline, Up to at Least 6 Months]

Критерии участия

Критерии включения

• Meet the diagnostic criteria for major depressive disorder
• Are on a stable standard of care medication for major depressive disorder
• 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 blinded study intervention, as directed
• maintain electronic and paper study diaries, as applicable, and
• complete the required questionnaires

Критерии исключения

• Have a lifetime history or current diagnosis of the following:

• schizophrenia or other psychotic disorder
• bipolar disorder
• borderline personality disorder, or
• any eating disorder.
• Have type 1 diabetes mellitus, or a history of

• ketoacidosis, or
• hyperosmolar state or coma.
• Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening
• Are actively suicidal or deemed a significant risk for suicide
• 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

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

• Accellacare - Moorpark — Moorpark
• ATP Clinical Research — Orange
• Yale University School of Medicine — New Haven
• Encore Medical Research — Hollywood
• K2 Medical Research - Maitland — Maitland
• Life Medical Research Group Corp — Miami Gardens
• Floridian Clinical Research, LLC — Miami Lakes
• CLA Research — Naples
• … и ещё 24 центра

Япония · 26 центров

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Китай · 20 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 Fourth People's Hospital of Chengdu — Чэнду
• Guangzhou Brain Hospital — Гуанчжоу
• Peking University Sixth Hospital — Haidian District
• Hefei No.4 People's Hospital — Хэфэй
• 3rd People's Hospital of Huzhou — Huzhou
• … и ещё 12 центров

Канада · 14 центров

• Heritage Medical Research Clinic — Calgary
• Premier Clinical Trial Network — Hamilton
• Kelowna Health and Memory Centre — Kelowna
• Alpha Recherche Clinique - Lévis — Lévis
• Genge Partners — Montreal
• Dar Clinical Research - Ottawa — Ottawa
• Centre de Recherche Saint-Louis inc. — Québec
• Alpha Recherche Clinique — Québec
• … и ещё 6 центров

Бразилия · 11 центров

• Hospital das Clínicas da UFMG — Belo Horizonte
• Trial Tech — Curitiba
• Clinilive — Maringá
• Centro de Pesquisa Clínica de Marília - CPCLIM — Marília
• Hospital Universitário Onofre Lopes — Natal
• Ruschel Medicina e Pesquisa Clínica — Rio de Janeiro
• Facili Centro Integrado de Psiquiatria — São Bernardo do Campo
• CPQuali Pesquisa Clínica — São Paulo
• … и ещё 3 центра

Великобритания · 10 центров

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Польша · 9 центров

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South Korea · 9 центров

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Испания · 9 центров

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Германия · 8 центров

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Мексика · 8 центров

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Тайвань · 8 центров

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Австралия · 7 центров

• NeuroCentrix — Carlton
• Lyell McEwin Hospital — Elizabeth Vale
• Barwon Health — Geelong
• Multidisciplinary Alfred Psychiatry Research Centre — Melbourne
• Paratus Clinical Research - Melbourne — Melbourne
• Toowoomba Hospital — Toowoomba
• Westmead Hospital — Westmead

Греция · 7 центров

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Пуэрто-Рико · 1 центр

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Идентификаторы

NCT: NCT07412756 · 27363 · 2025-522308-25-00 · J2S-MC-GZMH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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