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A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2 | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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)

NCT06931028•Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Peking University Third Hospital

Beijing, China

Key Dates

Start Date

June 12, 2025

Primary Completion Date

May 7, 2027

Completion Date

June 11, 2027

Last Updated

June 29, 2025

Enrollment

260

ESTIMATED participants

Conditions

Sleep ApneaObstructiveObesity

Interventions

placebo

OTHER

IBI362

DRUG

Contacts

baiyi yan

CONTACT

0512-69566088 baiyi.yan@innoventbio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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