Clinical Trial

A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2

Recruiting Phase 3
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-04-09; most recent amendment 2025-06-25.
Status change: Not Yet Recruiting → Recruiting 2025-06-25
Trial Details
NCT Number NCT06931028
Lead Sponsor Innovent Biologics (Suzhou) Co. Ltd.
Conditions Sleep Apnea, Obstructive, Obesity
Enrollment 260 participants
Start Date 2025-06-12
Primary Completion 2027-05-07 (estimated)
Study Completion 2027-06-11 (estimated)
Updated on ClinicalTrials.gov 2025-06-29