A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2
Trial Parameters
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of IBI362 in subjects with moderate-to-severe obstructive sleep apnea (OSA) and a body mass index (BMI) ≥28 kg/m2. Subjects will be randomly assigned to IBI362 9 mg and placebo groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 4-week screening period, a 48-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.
Eligibility Criteria
Inclusion Criteria: * For PAP s: Subjects who have received positive airway pressure (PAP) therapy for at least 3 consecutive months prior to screening and plan to continue PAP therapy during the study. * For non-PAP s:Subjects who are unable or unwilling to undergo PAP therapy. PAP must not have been used for at least 4 weeks prior to screening. * For all subjects: 1. Age ≥18 years at the time of signing informed consent. 2. Polysomnography (PSG) during screening shows an apnea-hypopnea index (AHI) ≥15 events/hour. 3. Body mass index (BMI) ≥28.0 kg/m² at screening. Exclusion Criteria: For PAPs： * 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 For all subjects： * Have type 1 diabetes mellitus (T1DM) or type