EUCTR2021-004552-41-CZ进行中（未招募）1 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)Indication-Specific Appendix (ISA2): Participants with OSA on PAP Therapy (12Feb2022) - SURMOUNT-OSA
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- 性别
- All
入选标准
- •BMI =30 kg/m2
- •Previously diagnosed moderate-to-severe OSA with an AHI =15, as
- •diagnosed with PSG, home sleep apnea test (HSAT), or other method
- •that meets local guidelines prior to screening
- •AHI =15 on PSG as part of the trial at screening
- •=18 years old
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 82
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 124
排除标准
- •T1DM or T2DM, history of ketoacidosis, or hyperosmolar state/coma
- •Laboratory evidence diagnostic of diabetes mellitus during screening,
- •including HbA1c =6.5% (=48 mmol/mol)
- •Prior or planned surgical treatment for obesity (excluding liposuction or
- •abdominoplasty if performed >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
- •Used GLP-1 <3 months prior to Screening
- •Use stimulants <3 months prior to Screening (e.g., monafinil,
- •armodafinil, solriamfetol, pitolisant, amphetamine, dextroamphetamine,
- •dexmethylphenidate, methylphnidate, lisdexampfetamine)
- •Current use or likely to require, in the opinion of the investigator,
- •concurrent treatment with systemic glucocorticoids (excluding topical,
- •intraocular, intranasal, intra-articular or inhaled preparations) in the
- •next 12 months.
- •Current or history of (<3 months prior to screening) treatment with
- •medications that may cause significant weight gain
- •Taken medications or alternative remedies intended to promote weight
- •loss <3 months prior to Screening
- •Have history of use of marijuana within 3 months of enrollment and
- •unwillingness to abstain from marijuana use during trial.
研究者
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