IBI362 for Chinese adults with obstructive sleep apnea and BMI ≥28

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)

This trial will see if once-weekly IBI362 injections help Chinese adults with moderate-to-severe obstructive sleep apnea who have a BMI of 28 or higher.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT06931028 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase III study enrolling adults with moderate-to-severe obstructive sleep apnea (AHI ≥15) and BMI ≥28 kg/m2. After a 4-week screening period including polysomnography, participants will be randomized to receive once-weekly subcutaneous IBI362 9 mg or placebo for 48 weeks, followed by a 12-week drug-withdrawal follow-up. The protocol includes participants who use positive airway pressure (PAP) therapy and those who do not, with PSG-based eligibility and on-study sleep assessments. Safety and efficacy outcomes will be compared between the IBI362 and placebo groups over the treatment and follow-up periods.

Who should consider this trial

Good fit: Adults (≥18 years) in China with polysomnography-confirmed moderate-to-severe OSA (AHI ≥15) and BMI ≥28 kg/m2 who meet the trial's PAP-use criteria are the intended participants.

Not a fit: People with mild OSA (AHI <15), BMI below 28, type 1 diabetes, or other protocol exclusions are unlikely to qualify or benefit from this trial.

Why it matters

Potential benefit: If effective, IBI362 could reduce sleep-disordered breathing and related health risks in people with obesity and moderate-to-severe OSA.

How similar studies have performed: Other clinical programs of weight-loss and metabolic agents have shown improvements in OSA severity in prior studies, but IBI362's efficacy for OSA is being tested here in a dedicated Phase III trial.

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 2 diabetes mellitus (T2DM).
* Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing at time of baseline
* Have significant craniofacial abnormalities that may affect breathing at baseline
* Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia.
* Active device treatment of OSA other than PAP therapy (for example, dental appliance), or other treatment, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at baseline and throughout the study.
* Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
* Have achieved a \>5% change in body weight through diet and exercise alone for at least 12 weeks prior to screening.

Where this trial is running

Beijing

• Peking University Third Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: baiyi yan

Conditions Sleep Apnea; Obstructive; Obesity