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

ConditionsSleep ApneaObstructiveObesity
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnovent Biologics (Suzhou) Co. Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Age ≥18 years at the time of signing informed consent.

Polysomnography (PSG) during screening shows an apnea-hypopnea index (AHI) ≥15 events/hour.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • placebo

    Other intervention

    placebo administered subcutaneously (SC) once a week.

  • IBI362

    Drug

    Once-weekly injections of gradually increased doses of IBI362

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: placeboPlacebo comparator 1 intervention
Group B: IBI362Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Week 48

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)

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.

Time frame
Week 48
4

Percentage of Participants with ≥50% AHI Reduction from Baseline

Time frame
Week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Innovent Biologics (Suzhou) Co. Ltd.

Lead sponsor

Source ClinicalTrials.gov
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