DelfaGLP-1 Atlas

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RecruitingPhase 3

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)

Asset

Mazdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

1

Recruiting sites

1

Enrollment

260

estimated

Study population

Obesity / overweight, Sleep apnea

Key I/E criterion

•BMI ≥28

Primary endpoint

•AHI, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06931028
Org study IDCIBI362E301

Timeline

Milestones

Study first posted2025-04-16actual
Study start2025-06-12actual
Last update posted2025-06-29actual
Primary completion2027-05-07estimated
Study completion2027-06-11estimated

Assets

Investigational agents

Mazdutide

Study populations

Who this study enrolls

Obesity / overweightSleep apnea

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
5
Weight & body composition
1
Cardiometabolic biomarkers
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Week 48

Body weight, % change

percent change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure (SBP)

Time frame:Week 48

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Other clinical outcomes

5 endpoints
Primary/protocol endpoint

Change from Baseline in Apnea-Hypopnea Index (AHI)

Time frame:Week 48

AHI, change

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Week 48

AHI, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants with ≥50% AHI Reduction from Baseline

Time frame:Week 48

OSA responder

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Week 48

OSA responder

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Week 48

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.