NCT06994650招募中3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The change of AHI form baseline after 52 weeks of treatment
研究概览
简要总结
This study is a phase 3 clinical trial, aiming to evaluate the efficacy and safety of HRS-9531 injection in obese subjects with obstructive sleep apnea (OSA) who are on positive airway pressure ventilation (PAP) therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 -75 (inclusive), male or female Sex
- •BMI ≥28.0 kg/m2；
- •≥3 months of diet/exercise control pre-screening with ≤5.0 kg weight fluctuation in prior 3 months.
- •Confirmed OSA diagnosis with screening PSG showing AHI ≥15.0 events/h.
- •≥3 months of PAP therapy pre-screening with planned continuation; willingness to pause PAP ≥1 week before each PSG.
- •Females/males of childbearing potential must use highly effective contraception from consent until 2 months post-treatment, with no pregnancy/donation plans. Females require negative pregnancy test ≤3 days pre-randomization and non-lactating.
排除标准
- •Endocrine disorders significantly affecting weight (e.g., Cushing's syndrome, hypo-/hyperthyroidism) or monogenic/hereditary obesity syndromes excluded.
- •Diabetes mellitus (excluding gestational diabetes).
- •Prior/planned OSA-related major surgeries (e.g., tonsillectomy/adenoidectomy) that may affect breathing.
- •Have significant craniofacial abnormalities that may affect breathing at baseline
- •Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration
- •Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
- •Impaired gastric emptying (e.g., gastric bypass, pyloric stenosis)；Chronic use of GI motility-affecting drugs；Severe GI disorders (e.g., active PUD, IBD)；GI surgeries (except non-motility-affecting procedures)
- •Pancreatic disorders (acute/chronic pancreatitis, pancreatic injury)；Acute cholecystitis history；Symptomatic/treated gallbladder disease
- •Have used drugs or treatments that may cause significant weight gain or loss within 3 months
- •Investigator-determined unsuitability/unwillingness to pause PAP therapy for at least 1 week pre-PSG (e.g., safety/occupational/personal considerations).
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
HRS9531
Experimental
干预措施: HRS9531 (Drug)
结局指标
主要结局
The change of AHI form baseline after 52 weeks of treatment
时间窗: 52 weeks
次要结局
- The percentage of subjects with ≥50% AHI reduction from baseline after 52 weeks of treatment;(52 weeks)
- The percentage change in AHI from baseline after 52 weeks of treatment(52 weeks)
- The percentage of subjects with AHI <5.0 events /h, or AHI ranging from 5.0 to 14.0 events/h and Epworth Sleepiness Scale (ESS) ≤10 after 52 weeks of treatment;(52 weeks)
- The percent change in body weight from baseline after 52 weeks of treatment.(52 weeks)
研究者
研究点 (1)
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