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)Intervention-Specific Appendix (ISA1, 10Feb2022: Participants with OSA unwilling or unable to use PAP therapy - SURMOUNT-OSA

Eli Lilly and Company0 个研究点目标入组 206 人开始时间: 2022年5月9日最近更新: 2024年6月3日

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•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
•Participants who are unwilling or unable to use PAP therapy
•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) no
•F.1.3.1 Number of subjects for this age range 124

•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.

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