This study is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of GZR18 injection in obese subjects with moderate to severe obstructive sleep apnea who are unable or unwilling to undergo positive airway pressure (PAP) therapy.
Subject is aged ≥18 years at the time of signing the informed consent form.
Body mass index (BMI) is ≥28 kg/m² at both screening and randomization.
Subject has a documented history of at least one unsuccessful attempt at weight loss through dietary control prior to screening, and has had <5% change in body weight during the 12 weeks prior to screening.
Subject has been diagnosed with obstructive sleep apnea (OSA) , and has a centrally assessed apnea-hypopnea index (AHI) ≥15 events/hour on polysomnography (PSG) at screening.
Known or suspected hypersensitivity to glucagon-like peptide-1 receptor agonists (GLP-1 RAs) or any of their excipients, or presence of a contraindication to GLP-1 RA use.
History of any type of diabetes mellitus (history of gestational diabetes is permitted).
Has undergone or plans to undergo during the study period surgical or device-based obesity treatment (exceptions: acupuncture, liposuction, or abdominal fat removal performed >1 year prior to screening; prior device-based obesity treatment is acceptable if the device was removed >1 year before screening).
Secondary obesity due to disease, medication, or other causes (e.g., Cushing's syndrome, Prader-Willi syndrome, monogenic obesity, or obesity secondary to hypothalamic/pituitary injury).
Parallel
Placebo
Drugsubcutaneous administration
GZR18 injection
Drugsubcutaneous administration
Change from baseline in Apnea-Hypopnea Index (AHI) after 52 weeks of treatment
Percentage change in AHI from baseline
Proportion of participants with ≥50% reduction in AHI from baseline
Proportion of participants achieving the following criteria：AHI < 5; or 5 ≤ AHI ≤ 14 and Epworth Sleepiness Scale (ESS) score ≤ 10
Percentage change in body weight from baseline
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This trial is not recruiting at the moment. You can still explore other options:
