A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: placebo, IBI362.
- Who it may be relevant to
- Registry conditions: Sleep Apnea, Obstructive, Obesity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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)
Overview
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.
Interventions
- Other placebo
placebo administered subcutaneously (SC) once a week. - Drug IBI362
Once-weekly injections of gradually increased doses of IBI362
Primary outcome measures
- Change from Baseline in Apnea-Hypopnea Index (AHI) [Time frame: Week 48]
Secondary outcome measures (6)
- Percent Change from Baseline in Body Weight [Time frame: Week 48]
- Change from Baseline in Systolic Blood Pressure (SBP) [Time frame: Week 48]
- Percent Change from Baseline in Apnea-Hypopnea Index (AHI) [Time frame: Week 48]
- Percentage of Participants with ≥50% AHI Reduction from Baseline [Time frame: Week 48]
- Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 [Time frame: Week 48]
- Change from Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) [Time frame: Week 48]
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:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Third Hospital — Beijing
Identifiers
NCT: NCT06931028 · CIBI362E301