NCT07225686招募中3 期
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy and Living With Overweight or Obesity
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Amgen
- 入组人数
- 250
- 试验地点
- 72
- 主要终点
- Change in Apnea-Hypopnea Index (AHI) from baseline at week 52
研究概览
简要总结
This Phase 3 clinical trial is designed to evaluate the efficacy and safety of maridebart cafraglutide compared to placebo over a 52-week period in adults with obstructive sleep apnea (OSA) who are receiving positive airway pressure (PAP) therapy and are living with overweight or obesity.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AHI ≥ 15 on polysomnography at day 1 before randomization.
- •BMI ≥ 27 kg/m^2 at screening.
- •History of at least 1 unsuccessful attempt at weight loss by diet and exercise.
- •On positive airway pressure (PAP) therapy for at least 3 consecutive months before screening and plan to continue PAP therapy during the trial.
排除标准
- •Had any previous or planned upper airway surgery or major ear, nose, or throat surgery for OSA.
- •Significant craniofacial abnormalities that may affect breathing at screening.
- •Diagnosis of Central or Mixed Sleep Apnea with proportion of mixed or central apneas/hypopneas ≥ 50%, and/or diagnosis of Cheyne Stokes Respiration.
- •Active device treatment of OSA other than PAP therapy (eg, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with study outcomes.
- •Respiratory diseases such as obesity hypoventilation syndrome or daytime hypercapnia, or neuromuscular diseases such as myasthenia gravis or other conditions that could interfere with the results of the trial in the opinion of the investigator.
- •Have personal circumstances or job-related responsibilities that prevent a 7-day PAP withdrawal before polysomnography testing during the course of the trial.
研究组 & 干预措施
Maridebart Cafraglutide
Experimental
Participants will receive maridebart cafraglutide subcutaneously (SC).
干预措施: Maridebart cafraglutide (Drug)
Placebo
Placebo Comparator
Participants will receive placebo SC.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Apnea-Hypopnea Index (AHI) from baseline at week 52
时间窗: At week 52
Change in AHI from baseline at week 52
时间窗: At Week 52
次要结局
- Percentage change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at week 52(At week 52)
- Percentage Change in AHI from baseline at week 52(At week 52)
- Participants Achieving ≥ 50% AHI Reduction from baseline at week 52(At week 52)
- Participants Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤ 10 from baseline at week 52(At week 52)
- Percentage Change in Body Weight from baseline at week 52(At week 52)
- Change in Sleep Apnea-specific Hypoxic Burden (SASHB) from baseline at week 52(At week 52)
- Change in Systolic Blood Pressure from baseline at week 48(At week 48)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-related Impairment 8a Score from baseline at week 52(At week 52)
- Change in AHI from baseline at week 24(At week 24)
- Percentage change in AHI from baseline at week 24(At week 24)
- Change in SASHB from baseline at week 24(At week 24)
- Change in ESS score from baseline at week 52(At week 52)
- Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score from baseline at week 52(At week 52)
- Change in Short Form-36 Health Survey Version 2 (SF-36v2) Acute domain and summary scores from baseline at week 52(At week 52)
- Change from baseline at week 52 in Patient Global Impression of Severity (PGI-S) Sleep-related impairment, Sleep quality, and Sleepiness.(At week 52)
- Percentage of participants achieving ≥ 10% reduction in body weight from baseline at week 52(At week 52)
- Percentage of participants achieving ≥ 15% reduction in body weight from baseline at week 52(At week 52)
- Percentage of participants achieving ≥ 20% reduction in body weight from baseline at week 52(At week 52)
- Change in waist circumference from baseline at week 52(At week 52)
- Change in waist-to-height ratio from baseline at week 52(At week 52)
- Change in neck circumference from baseline at week 52(At week 52)
- Percentage change in Total Cholesterol, High-density lipoprotein cholesterol (HDL-C), Non-HDL-C, Low-density lipoprotein cholesterol (LDL-C), and Triglycerides from baseline at week 52 in fasting conditions(At week 52)
- Percent change from baseline at week 52 in fasting insulin(At week 52)
- Change from baseline at week 52 in fasting plasma glucose (FPG) (mg/dL, mmol/L)(At week 52)
- Change in hemoglobin A1c (HbA1c) (%, mmol/mol) from baseline at week 52(At week 52)
- Change in Diastolic Blood Pressure (DBP) from baseline at week 48(At week 48)
- Number of participants with Treatment-Emergent Adverse Events and Serious Adverse Events(Up to 100 weeks)
- Plasma concentration of maridebart cafraglutide at week 52(At week 52)
- Percentage Change in AHI from baseline at week 52(At Week 52)
- Participants Achieving ≥ 50% AHI Reduction from baseline at week 52(At Week 52)
- Participants Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤ 10 from baseline at week 52(At Week 52)
- Percentage Change in Body Weight from baseline at Week 52(At Week 52)
- Change in Sleep Apnea-specific Hypoxic Burden (SASHB) from baseline at Week 52(At Week 52)
- Change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at Week 52(At Week 52)
- Change in Systolic Blood Pressure from baseline at Week 48(At Week 48)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-related Impairment 8a Score from baseline at Week 52(At Week 52)
研究者
研究点 (72)
Loading locations...
相似试验
招募中
3 期
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or ObesityObesityNCT07037433Amgen12,800
进行中（未招募）
3 期
Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are OverweightObesityNCT06858839Amgen3,853
进行中（未招募）
3 期
Efficacy and Safety of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity DiseaseNCT06987695Amgen279
进行中（未招募）
3 期
Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are OverweightNCT06858878Amgen1,105
招募中
3 期
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and ObesityObesityNCT07037459Amgen5,056