NCT06931028

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

A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Assess the Efficacy and Safety of IBI362 in Chinese Subjects With Moderate-to-Severe Obstructive Sleep Apnea and BMI≥28 kg/m2 (GLORY-OSA)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Apnea
• Obstructive
• Obesity

Interventions

Type	Name	Description
OTHER	placebo	placebo administered subcutaneously (SC) once a week.
DRUG	IBI362	Once-weekly injections of gradually increased doses of IBI362

Timeline

• Start date: 2025-06-12
• Primary completion: 2027-05-07
• Completion: 2027-06-11
• First posted: 2025-04-16
• Last updated: 2025-06-29

Locations

1 site across 1 country: China