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This study is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of GZR18 injection in obese subjects with moderate to severe obstructive sleep apnea who are unable or unwilling to undergo positive airway pressure (PAP) therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GZR18 injection | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | subcutaneous administration |
| |
| GZR18 injection |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Apnea-Hypopnea Index (AHI) after 52 weeks of treatment | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in AHI from baseline | 52weeks | |
| Proportion of participants with ≥50% reduction in AHI from baseline | 52 weeks | |
| Proportion of participants achieving the following criteria:AHI < 5; or 5 ≤ AHI ≤ 14 and Epworth Sleepiness Scale (ESS) score ≤ 10 |
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Inclusion Criteria:
Subject is aged ≥18 years at the time of signing the informed consent form.
Body mass index (BMI) is ≥28 kg/m² at both screening and randomization.
Subject has a documented history of at least one unsuccessful attempt at weight loss through dietary control prior to screening, and has had <5% change in body weight during the 12 weeks prior to screening.
Subject has been diagnosed with obstructive sleep apnea (OSA) , and has a centrally assessed apnea-hypopnea index (AHI) ≥15 events/hour on polysomnography (PSG) at screening.
Unable or unwilling to receive PAP therapy before screening, and not planning to initiate PAP therapy during the study period.
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| na ou | Contact | 15288850128 | na.ou@ganlee.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gan & Lee Pharmaceuticals | Beijing | China |
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| Drug |
subcutaneous administration |
|
| 52 weeks |
| Percentage change in body weight from baseline | 52 weeks |
| Proportion of subjects whose body weight decreased by ≥ 5%, ≥ 10%, ≥ 15%, or ≥ 20% relative to baseline | 52 weeks |
| Change in body weight (kg) and body mass index (kg/㎡) relative to baseline | 52 weeks |
| Change in neck circumference and waist circumference relative to the baseline | 52 weeks |
| Change in high-sensitivity C-reactive protein (hsCRP) relative to baseline | 52 weeks |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| 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 |
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