2025-522703-14-00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 (MARITIME-OSA-1)
Amgen Inc.8 个研究点 分布在 2 个国家目标入组 45 人开始时间: 2026年2月10日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 8
- 主要终点
- Change in AHI from baseline at week 52
研究概览
简要总结
To demonstrate that maridebart cafraglutide is superior to placebo for improvement in Apnea-Hypopnea Index (AHI)
研究设计
- 分配方式
- Randomized
- 主要目的
- Period 2
- 盲法
- Double (Carer, Investigator, Subject, Analyst, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participant has provided informed consent before initiation of any study-specific activities/procedures.
- •Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
- •Documented history of previously diagnosed moderate-to-severe OSA with an AHI ≥ 15, as diagnosed with PSG, HSAT (REI ≥ 15 by HSAT), or other method that meets local guidelines before screening.
- •AHI ≥ 15 on PSG at day 1 before randomization.
- •BMI ≥ 27 kg/m2 at screening.
- •History of at least 1 unsuccessful attempt at weight loss by diet and exercise.
- •On PAP therapy for at least 3 consecutive months before screening and plan to continue PAP therapy during the study
排除标准
- •Had any previous or planned upper airway surgery for sleep apnea or major ear, nose, or throat surgery
- •Previous or planned (during the study) surgical, endoscopic, or device-based treatment for obesity.
- •Have Type 1 or Type 2 Diabetes Mellitus, or any other type of diabetes, history of ketoacidosis, or hyperosmolar state/coma
- •History of clinically relevant medical, behavioral, or psychiatric disorder, other than OSA, that is associated with insomnia or excessive sleepiness.
- •History of malignancy within the last 5 years before screening (except nonmelanoma skin cancers, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ that have been treated with curative intent).
- •History of chronic pancreatitis.
- •History of acute pancreatitis within 180 days before screening.
- •Significant craniofacial abnormalities that may affect breathing at screening.
- •Diagnosis of Central Apnea with % of 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, unless willing to stop treatment at screening and throughout the study
- •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 PSG testing during the course of the study
- •Are unwilling or unsafe in the opinion of investigator to stop PAP therapy for 7 days before PSG testing during the course of the study
- •Obesity induced by other endocrine disorders or monogenetic or syndromic forms of obesity.
- •Self-reported change in body weight > 5 kg within 90 days before screening.
结局指标
主要结局
Change in AHI from baseline at week 52
Change in AHI from baseline at week 52
次要结局
- " Percent change in AHI from baseline at week 52 Achieving ≥ 50% AHI reduction from baseline at week 52 Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤10 at week 52 Change in Sleep Apnea-specific Hypoxic burden (%/min/hour) from baseline at week 52"
- " Percent change in body weight from baseline at week 52 Change in high sensitivity C-reactive protein (hs-CRP) from baseline at week 52 Change in SBP (mmHg) from baseline at Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score from baseline at week 52"
研究者
Medical Information
Scientific
Amgen Inc.
研究点 (8)
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