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

NCT06931028 | Recruiting Phase 3

• 1 other identifier: CIBI362E301
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  Week 48

Secondary Outcomes (6)

• Percent Change from Baseline in Body Weight

  Week 48

• Change from Baseline in Systolic Blood Pressure (SBP)

  Week 48

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

  Week 48

• Percentage of Participants with ≥50% AHI Reduction from Baseline

  Week 48

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

  Week 48

Study Arms (2)

placebo

PLACEBO COMPARATOR

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

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

Drug: IBI362

Interventions

placebo OTHER

placebo administered subcutaneously (SC) once a week.

placebo

IBI362 DRUG

Once-weekly injections of gradually increased doses of IBI362

IBI362

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Obesity

Interventions

mazdutide

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

baiyi yan

CONTACT

0512-69566088; baiyi.yan@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): May 7, 2027
• Study Completion (Estimated): June 11, 2027
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)