A Study of XW003 in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy

Официальное название

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study to Assess the Efficacy and Safety of XW003 Injections in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy

Обзор

The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA but not receiving PAP

Подробное описание

In this Phase III study, eligible participants will be randomized into one of the two cohorts in a 1:1 ratio to receive once-weekly subcutaneous XW003 injection or placebo, including a dose-escalation period, for up to 48 weeks.

Вмешательства

• Препарат XW003 injection
  subcutaneous injection
• Препарат placebo with matching volume
  subcutaneous injection

Первичные конечные точки

• Change from baseline in Apnea-Hypopnea Index (AHI) [Срок оценки: at week 48]

Вторичные конечные точки (4)

• Percent Change From Baseline in AHI [Срок оценки: at week 48]
• Percentage of Participants With ≥50% AHI Reduction From Baseline [Срок оценки: at week 48]
• Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10 [Срок оценки: at week 48]
• Percent Change From Baseline in Body Weight [Срок оценки: at week 48]

Критерии участия

Критерии включения

• Body mass index (BMI) ≥ 28.0 kg/m2;
• The results of PSG meet the diagnosis criteria of OSA and with an AHI ≥15 at screening;
• Participants must not have used PAP for at least 4 weeks prior to screening and not use PAP during the study;
• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Критерии исключения

• History of endocrine disorders which have significant impact on body weight;
• Diagnosis of diabetes (except gestational diabetes), ketoacidosis or hypertonic state/coma;
• HbA1c ≥6.5% at screening;
• Fasting blood glucose ≥7.0 mmol/L or 2-hour blood glucose ≥11.1 mmol/L after oral glucose tolerance test (OGTT) at screening; participants with FBG ≥6.1 mmol/L but <7.0 mmol/L require OGTT;
• Have diagnosis of Cheyne Stokes Respiration, or diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%;
• Respiratory and neuromuscular diseases that could interfere with the results of the trial;
• Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia;
• Change of body weight >5% within 3 months prior to screening (self-reported);
• Have a prior or planned surgical treatment for obesity (except liposuction or abdominoplasty if performed more than 1 year prior to screening);
• Have received any medication for body weight loss and blood glucose lowering or medication that could lead to significant body weight increase, within 3 months 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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT07387094 · SCW0502-5031

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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