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Идёт набор NCT06931028

A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2

Фаза III С лечением Sleep Apnea Obstructive Obesity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: placebo, IBI362.
Кому может быть актуально
Состояния в реестре: Sleep Apnea, Obstructive, Obesity. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Assess the Efficacy and Safety of IBI362 in Chinese Subjects With Moderate-to-Severe Obstructive Sleep Apnea and BMI≥28 kg/m2 (GLORY-OSA)

Обзор

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of IBI362 in subjects with moderate-to-severe obstructive sleep apnea (OSA) and a body mass index (BMI) ≥28 kg/m2. Subjects will be randomly assigned to IBI362 9 mg and placebo groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 4-week screening period, a 48-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.

Вмешательства

  • Другое placebo
    placebo administered subcutaneously (SC) once a week.
  • Препарат IBI362
    Once-weekly injections of gradually increased doses of IBI362

Первичные конечные точки

  • Change from Baseline in Apnea-Hypopnea Index (AHI) [Срок оценки: Week 48]
Вторичные конечные точки (6)
  • Percent Change from Baseline in Body Weight [Срок оценки: Week 48]
  • Change from Baseline in Systolic Blood Pressure (SBP) [Срок оценки: Week 48]
  • Percent Change from Baseline in Apnea-Hypopnea Index (AHI) [Срок оценки: Week 48]
  • Percentage of Participants with ≥50% AHI Reduction from Baseline [Срок оценки: Week 48]
  • Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 [Срок оценки: Week 48]
  • Change from Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) [Срок оценки: Week 48]

Критерии участия

Критерии включения

  • For PAP s: Subjects who have received positive airway pressure (PAP) therapy for at least 3 consecutive months prior to screening and plan to continue PAP therapy during the study.
  • For non-PAP s:Subjects who are unable or unwilling to undergo PAP therapy. PAP must not have been used for at least 4 weeks prior to screening.
  • For all subjects:
  • Age ≥18 years at the time of signing informed consent.
  • Polysomnography (PSG) during screening shows an apnea-hypopnea index (AHI) ≥15 events/hour.
  • Body mass index (BMI) ≥28.0 kg/m² at screening.

Критерии исключения

For PAPs：

  • Have personal or job-related responsibilities, or in the opinion of the investigator have any situation, that would make it unsafe to stop PAP therapy for 7 days prior to PSG testing during the course of the study
  • Are unwilling to stop PAP therapy for 7 days prior to polysomnography (PSG) testing during the course of the study For all subjects：
  • Have type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM).
  • Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing at time of baseline
  • Have significant craniofacial abnormalities that may affect breathing at baseline
  • Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia.
  • Active device treatment of OSA other than PAP therapy (for example, dental appliance), or other treatment, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at baseline and throughout the study.
  • Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
  • Have achieved a >5% change in body weight through diet and exercise alone for at least 12 weeks prior to 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
Тройное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT06931028 · CIBI362E301

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗