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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
260
placebo administered subcutaneously (SC) once a week.
Once-weekly injections of gradually increased doses of IBI362
Peking University Third Hospital
Beijing, China
RECRUITINGChange from Baseline in Apnea-Hypopnea Index (AHI)
AHI is defined as the average number of apnea and hypopnea events per hour of sleep, which is determined by polysomnography. The lower the value, the better, and the normal range is \<5 events/hour.
Time frame: Week 48
Percent Change from Baseline in Body Weight
Time frame: Week 48
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame: Week 48
Percent Change from Baseline in Apnea-Hypopnea Index (AHI)
AHI is defined as the average number of apnea and hypopnea events per hour of sleep, which is determined by polysomnography. The lower the value, the better, and the normal range is \<5 events/hour.
Time frame: Week 48
Percentage of Participants with ≥50% AHI Reduction from Baseline
Time frame: Week 48
Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10
Time frame: Week 48
Change from Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB)
SASHB is an indicator that quantifies the cumulative effect of hypoxia caused by apnea or hypopnea events during sleep. It is also calculated based on the results of polysomnography. It combines the severity, duration and frequency of hypoxia, and can more comprehensively reflect the systemic damage of hypoxia to the body. It is an important predictive factor for increased CVD risk. The lower the value, the better.
Time frame: Week 48
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