jRCT2031240499进行中（未招募）不适用
A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obstructive Sleep Apnea and Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (J5P-MC-GZRA)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Master GZRA inclusion criteria
- •have AHI >=15 on PSG as part of the trial at screening (V1).
- •have body mass index (BMI) >=27 kg/m2
- •Study 1 GZ01 inclusion criteria
- •Participants who are unable or unwilling to use PAP therapy.
- •Participants must not have used PAP for at least 4 weeks prior to screening.
- •Study 2 GZ02 inclusion criteria
- •Participants who have been on PAP therapy for at least 3 consecutive months prior to study start and plan to continue PAP therapy during the study.
排除标准
- •Master GZRA exclusion criteria
- •Have Type 1 diabetes (T1D) or Type 2 diabetes (T2D), history of ketoacidosis, or hyperosmolar state/coma
- •Have HbA1c >=6.5% (>= 48 mmol/mol), as determined by the central laboratory at Visit
- •Had any previous or planned upper airway surgery for sleep apnea or major ear, nose or throat surgery
- •Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas >=50%, or diagnosis of Cheyne Stokes Respiration
- •Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia.
- •Active device treatment of OSA other than PAP therapy
- •Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
- •Have a self-reported change in body weight >5 kg within 3 months prior to screening
- •Have a prior or planned surgical treatment for obesity (excluding liposuction, abdominoplasty or cryolipolysis if performed more than 1 year prior to screening)
- •Have a prior or planned endoscopic and/or present device-based therapy for obesity.
- •Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity.
- •Study 2 GZ02 exclusion criteria
- •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 study.
- •Are unwilling to temporary discontinue PAP therapy for 7 days prior to PSG testing during the study.
结局指标
主要结局
-
Change from Baseline in Apnea-Hypopnea Index (AHI) [ Time Frame: Baseline to Week 52
次要结局
未报告次要终点
研究者
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