NCT07387094招募中3 期
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
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change from baseline in Apnea-Hypopnea Index (AHI)
研究概览
简要总结
The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA but not receiving PAP
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
Placebo Comparator
once weekly
干预措施: placebo with matching volume (Drug)
XW003 Injection
Experimental
once weekly
干预措施: XW003 injection (Drug)
结局指标
主要结局
Change from baseline in Apnea-Hypopnea Index (AHI)
时间窗: at week 48
次要结局
- Percent Change From Baseline in AHI(at week 48)
- Percentage of Participants With ≥50% AHI Reduction From Baseline(at week 48)
- Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10(at week 48)
- Percent Change From Baseline in Body Weight(at week 48)
研究者
研究点 (1)
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