NCT07226765进行中（未招募）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 Not on Positive Airway Pressure Therapy and Living With Overweight or Obesity (MARITIME-OSA-2)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen
- 入组人数
- 250
- 试验地点
- 119
- 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 not on PAP therapy and are living with overweight or obesity.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 双盲 (受试者、研究者)
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
- Participants must have an AHI of 15 or higher on polysomnography (PSG) at Day 1 before randomization.
- Body Mass Index (BMI) of 27 kg/m^2 or more at the time of screening.
- History of at least one unsuccessful attempt at weight loss through diet and exercise.
- Participants must not have used PAP therapy for at least 4 weeks before screening, are unwilling/unable to use PAP, and do not plan to use PAP therapy during the study.
排除标准
- Individuals who have had any previous or planned upper airway surgery or major ear, nose or throat surgery for OSA.
- Those with significant craniofacial abnormalities that may affect breathing at screening.
- Participants diagnosed with 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 or other treatments, that in the opinion of the investigator, may interfere with study outcomes.
- Individuals with respiratory diseases like obesity hypoventilation syndrome or daytime hypercapnia, neuromuscular diseases or other conditions that could interfere with the trial results, according to the investigator's opinion.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive placebo SC.
干预措施: Placebo (Drug)
Maridebart Cafraglutide
Experimental
Participants will receive maridebart cafraglutide subcutaneously (SC).
干预措施: Maridebart cafraglutide (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
次要结局
- Percent Change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at Week 52(At Week 52)
- Change in AHI from Baseline at Week 24(At Week 24)
- Percent 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-related Impairment 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 in Patient Global Impression of Severity (PGI-S) Sleep-Related Impairment, Sleep Quality, Sleepiness from Baseline at Week 52(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 in Fasting Insulin From Baseline at Week 52(At Week 52)
- Change in Fasting Plasma Glucose (FPG) (mg/dL, mmol/L) From Baseline at Week 52(At Week 52)
- Change in Hemoglobin A1c 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 Week 100)
- Plasma Concentration of Maridebart Cafraglutide at Week 52(At Week 52)
- Percent 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)
- Percent 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 (SBP) 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 (119)
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标识符
- NCT 编号
- NCT07226765
- 其他研究编号
- 20250002
日期
- 首次提交
- (10个月前)
- 首次发布
- (10个月前)
- 主要完成日期
- (11个月后)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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