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NCT Number: NCT06931028

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University Third Hospital

Beijing, 100191, China

Location status: Recruiting

Location contact

tianpei hong

CONTACT

[email protected]

010-82266918

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Age ≥18 years at the time of signing informed consent.
  • Polysomnography (PSG) during screening shows an apnea-hypopnea index (AHI) ≥15 events/hour.
  • 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.

Treatment and study plan

Placebo

Other

placebo administered subcutaneously (SC) once a week.

IBI362

Drug

Once-weekly injections of gradually increased doses of IBI362

Primary outcomes

  1. Change from Baseline in Apnea-Hypopnea Index (AHI)

    Time frame: Week 48

    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.

Secondary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: Week 48

  2. Change from Baseline in Systolic Blood Pressure (SBP)

    Time frame: Week 48

  3. Percent Change from Baseline in Apnea-Hypopnea Index (AHI)

    Time frame: Week 48

    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.

  4. Percentage of Participants with ≥50% AHI Reduction from Baseline

    Time frame: Week 48

  5. Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10

    Time frame: Week 48

  6. Change from Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB)

    Time frame: Week 48

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

baiyi yan

CONTACT

[email protected]

0512-69566088

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 16, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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