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

NCTNCT06931028Other idCIBI362E301

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Overview

Status: Recruiting
Phase: Phase 3
Enrollment: 260 participants (estimated)
Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
Design: Randomized · Triple masking
Countries: 1 country
China
Start: 12 Jun 2025
Primary completion: 7 May 2027 (estimated)
Completion: 11 Jun 2027 (estimated)
First posted: 16 Apr 2025
Last update posted: 29 Jun 2025
Conditions: Sleep Apnea · Obstructive · Obesity

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2025202620272028

Ph 3
A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2
NCT06931028
12 Jun 2025 to est. 11 Jun 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

placeboOther
IBI362Drug

Arms2

Placebo comparator
placebo
Participants receive placebo by subcutaneous (SC) injection once a week.
Experimental
IBI362
①2mg, SC, once a week\* 4weeks; ②4mg, SC, once a week\* 4weeks；③6mg, SC, once a week\* 4weeks，9mg,SC,once a week\* 36weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

Change from Baseline in Apnea-Hypopnea Index (AHI)
Time frame · Week 48
Registry description
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(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
Registry description
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.
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
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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