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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | Participants receive placebo by subcutaneous (SC) injection once a week. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Other | placebo administered subcutaneously (SC) once a week. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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:
Exclusion Criteria:
For PAPs:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| baiyi yan | Contact | 0512-69566088 | baiyi.yan@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | 100191 | China |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| C000719829 | mazdutide |
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| IBI362 |
| Drug |
Once-weekly injections of gradually increased doses of IBI362 |
|
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 |
| 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 |
| 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. | Week 48 |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |