JPRN-jRCT2031220155进行中（未招募）3 期
A Master Protocol to Investigate the Efficacy and Safety of Tirzepatide Once Weekly in Participants who have Obstructive Sleep Apnea and Obesity: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-OSA)ISA2 (GPI2): Participants with OSA on PAP Therapy - I8F-MC-GPI2
Masaki Takeshi0 个研究点目标入组 206 人开始时间: 2022年6月22日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 206
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Have been on PAP therapy for at least 3 consecutive months prior to screening and plan to continue PAP therapy during the study.
- •- Have an AHI >=15 on PSG as part of the trial at screening
- •- Have a body mass index (BMI) >=30 kilogram/square meter (kg/m2)
- •- Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
排除标准
- •-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
- •-Female participants must not be pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed.
- •-Have type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), history of ketoacidosis, or hyperosmolar state/coma.
- •-Have HbA1c >= 6.5% (>= 48 mmol/mol) at baseline
- •-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
- •-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 (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 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 or abdominoplasty if performed more than 1 year prior to screening)
- •-Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months (for example, mucosal ablation, gastric artery embolization, intragastric balloon, and duodenal-jejunal bypass sleeve)
研究者
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The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP) therapy in GPI-1JPRN-jRCT2031220154Masaki Takeshi206