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

NCT ID: NCT06931028

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-12
• Study Completion Date: 2027-06-11

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

placebo

Participants receive placebo by subcutaneous (SC) injection once a week.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

placebo administered subcutaneously (SC) once a week.

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

Group Type: EXPERIMENTAL

IBI362

Intervention Type: DRUG

Once-weekly injections of gradually increased doses of IBI362

Interventions

placebo

placebo administered subcutaneously (SC) once a week.

Intervention Type: OTHER

IBI362

Once-weekly injections of gradually increased doses of IBI362

Intervention Type: DRUG

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:

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Third Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

baiyi yan

Role: CONTACT

baiyi.yan@innoventbio.com

0512-69566088

Facility Contacts

tianpei hong

Role: primary

tpho66@bjmu.edu.cn

010-82266918

Other Identifiers

CIBI362E301

Identifier Type: -

Identifier Source: org_study_id