Sleep ApneaPhase 3NCT06931028
A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2
A Phase 3 study testing IBI362 in people with Sleep Apnea and Obstructive, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive, Obesity
- What is being tested?
- IBI362
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2025to 11 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, 100191
tianpei hong, 010-82266918, tpho66@bjmu.edu.cn
About this study
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)
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.
- Conditions
- Sleep Apnea, Obstructive, Obesity
- Being tested
- placebo, IBI362
- Medical subject headings
- Sleep Apnea Syndromes, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
placebo administered subcutaneously (SC) once a week.
IBI362Drug
Once-weekly injections of gradually increased doses of IBI362
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Participants receive placebo by subcutaneous (SC) injection once a week. Receives: Other: placebo |
| IBI362 | Experimental | ①2mg, SC, once a week* 4weeks; ②4mg, SC, once a week* 4weeks；③6mg, SC, once a week* 4weeks，9mg,SC,once a week* 36weeks Receives: Drug: IBI362 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Apnea-Hypopnea Index (AHI)
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.
Measured: Week 48
Secondary outcomes (6)
Percent Change from Baseline in Body Weight
Measured: Week 48
Change from Baseline in Systolic Blood Pressure (SBP)
Measured: Week 48
Percent Change from Baseline in Apnea-Hypopnea Index (AHI)
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.
Measured: Week 48
Percentage of Participants with ≥50% AHI Reduction from Baseline
Measured: Week 48
Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10
Measured: Week 48
Change from Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB)
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.
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start12 Jun 2025
- Primary completion7 May 2027 (estimated)
- Study completion11 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931028
- Sponsor's protocol ID
- CIBI362E301
- Status last verified
- Jun 2025
- First submitted
- 9 Apr 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06931028
- Acronym / sponsor ID
- CIBI362E301
- Conditions
- Sleep Apnea, Obstructive, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 7 May 2027 (estimated)
- Study completion
- 11 Jun 2027 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: placeboParticipants receive placebo by subcutaneous (SC) injection once a week. |
| IBI362 | Experimental | Drug: IBI362①2mg, SC, once a week* 4weeks; ②4mg, SC, once a week* 4weeks；③6mg, SC, once a week* 4weeks，9mg,SC,once a week* 36weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboplacebo administered subcutaneously (SC) once a week. | Other | placebo |
| IBI362Once-weekly injections of gradually increased doses of IBI362 | Drug | IBI362 |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Sleep Apnea
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IBI362 in people with Sleep Apnea and Obstructive, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact baiyi yan (0512-69566088, baiyi.yan@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Apnea-Hypopnea Index (AHI) (time frame: Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.