NCT07787260尚未招募3 期
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of HDM1005 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Not Receiving Positive Airway Pressure (PAP) Therapy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Percentage change in body weight from baseline at week 52
研究概览
简要总结
This is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy and safety of the HDM1005 in patients with obstructive sleep apnea (OSA) and obesity not receiving positive airway pressure (PAP) therapy. Eligible participants will be screened and randomized to the HDM1005 group or the placebo group at a ratio of 1:1 , HDM1005 or placebo will be given once weekly for 52 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.
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
- •Age between 18 and 75 years, male or female, at the time of signing the informed consent form.
- •BMI ≥ 28.0 kg/m² at both screening and randomization.
- •A self-reported change in body weight no more than 5% within 90 days before screening.
- •Subject has been diagnosed with obstructive sleep apnea (OSA) according to the International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria prior to screening, 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.
排除标准
- •History of any type of diabetes mellitus (history of gestational diabetes is permitted).
- •Have obesity induced by other endocrinologic disorders or by other medicine.
- •History of thyroid C-cell carcinoma, multiple endocrine neoplasia type 2 (MEN2) or relevant family history.
- •Diagnosis of central or mixed sleep apnea or Cheyne-Stokes respiration.
- •Respiratory or neuromuscular diseases judged by the investigator to potentially interfere with trial results.
- •Clinical abnormalities or diseases related to insomnia or excessive sleepiness (excluding OSA).
- •Uncontrolled hypertension prior to screening, defined as: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg (stable for 1 month if using antihypertensive drugs).
- •History of malignancy (except cured basal cell carcinoma) in the past 5 years or at the time of screening.
- •History of severe cardiovascular or cerebrovascular diseases within the past six months.
- •The subject has any other factors that may affect the efficacy or safety evaluation of this study, and is not suitable for participation in this study in the opinion of the investigator.
结局指标
主要结局
Percentage change in body weight from baseline at week 52
时间窗: 52 week
Change in AHI from baseline at week 52
时间窗: 52 week
次要结局
- Percentage change in AHI from baseline(52 week)
- Proportion of participants with ≥50% reduction in AHI from baseline(52 week)
- Proportion of participants achieving the following criteria：AHI < 5; or 5 ≤ AHI ≤ 14 and Epworth Sleepiness Scale (ESS) score ≤ 10(52 week)
- Proportion of subjects whose body weight decreased by ≥ 5%, ≥ 10%, or ≥ 15% relative to baseline(52 week)
- Change in Epworth Sleepiness Scale (ESS) Score from Baseline at Week 52 of Treatment(52 week)
- Proportion of subjects reporting improvement in Patient Global Impression of Severity (PGIS)-OSA categories at Week 52 of treatment.(52 week)
- Incidence of adverse events (AEs)(52 week)
研究者
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