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AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea (AMAZE 4)

2026年9月8日 更新者:Novo Nordisk A/S

Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Obstructive Sleep Apnoea Treated With Positive Airway Pressure (AMAZE 4)

This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.

研究概览

研究类型

介入性

注册 (估计的)

300

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100044
        • 招聘中
        • Peking University People's Hospital-Endocrinology
    • Guangdong
      • Guangzhou、Guangdong、中国、510515
        • 尚未招聘
        • Nanfang Hospital, Southern Medical University-Department of Psychiatry and Psychology
      • Shenzhen、Guangdong、中国、518020
        • 尚未招聘
        • Shenzhen People's Hospital-Sleep Medicine Department
    • Henan
      • Luoyang、Henan、中国、471003
        • 尚未招聘
        • The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology
    • Jiangsu
      • Nanjing、Jiangsu、中国、210011
        • 招聘中
        • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
    • Tianjin Municipality
      • Tianjin、Tianjin Municipality、中国、300052
        • 尚未招聘
        • Tianjin Medical University General Hospital-Respiratory
      • Jaipur、印度、302039
        • 招聘中
        • Asthma Bhawan
    • Andhra Pradesh
      • Guntur、Andhra Pradesh、印度、522004,
        • 完全的
        • Guntur Government medical College
      • Vijayawada、Andhra Pradesh、印度、520008
        • 招聘中
        • Government Siddhartha Medical College & Government General Hospital, Vijayawada
    • Karnataka
      • Bengaluru、Karnataka、印度、560074
        • 招聘中
        • Rajarajeswari Medical College and Hospital
    • Kerala
      • Kochi、Kerala、印度、682041
        • 招聘中
        • Amrita Institute of Medical Sciences & Research Centre
    • Maharashtra
      • Mumbai、Maharashtra、印度、401107
        • 招聘中
        • Bhaktivedanta Hospital & Research Institute
      • Nagpur、Maharashtra、印度、440010
        • 招聘中
        • Asian Kidney Hospital And Medical Centre
    • National Capital Territory of Delhi
      • New Delhi、National Capital Territory of Delhi、印度、110029
        • 尚未招聘
        • Vardhaman Mahavir Medical College & Safdarjung Hospital
    • New Delhi
      • Delhi、New Delhi、印度、110029
        • 招聘中
        • All India Institute of Medical Sciences_Delhi
    • Odisha
      • Bhubaneswar、Odisha、印度、751019
        • 尚未招聘
        • All India Institute of Medical Sciences (AIIMS), Bhubaneswar
    • Telangana
      • Hyderabad、Telangana、印度、500084
        • 完全的
        • Yashoda Hospital
    • Uttar Pradesh
      • Lucknow、Uttar Pradesh、印度、226006
        • 招聘中
        • Midland Healthcare & Research Center
    • West Bengal
      • Kolkata、West Bengal、印度、700054
        • 招聘中
        • Apollo Multispeciality Hospital, Kolkata
      • Chiayi City、台湾、600
        • 尚未招聘
        • Ditmanson Medical Foundation Chia-Yi Christian Hospital
      • Taipei、台湾、110
        • 招聘中
        • Taipei Medical University Hospital
      • Taipei、台湾、106
        • 招聘中
        • Cathay General Hospital
      • Taipei、台湾、116
        • 招聘中
        • Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology
      • Taoyuan、台湾、333
        • 招聘中
        • Chang Gung Memorial Hospital, Linkou
      • Alanya/ Antalya、土耳其(türkiye)、07400
        • 招聘中
        • T.C. Sağlık Bakanlığı Alaaddin Keykubat Üniversitesi Alanya Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
      • Maltepe/İstanbull、土耳其(türkiye)、34843
        • 招聘中
        • İstanbul İl Sağlik Müdürlüğü Süreyyapaşa Göğüs Hastaliklari Ve Göğüs Cerrahisi Eğitim Ve Araştirma Hastanesi
      • Merkez/Battalgazi/Malatya、土耳其(türkiye)、44280
        • 招聘中
        • İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları
      • Merkez/Çorum、土耳其(türkiye)、19040
        • 招聘中
        • Hitit Üniversitesi Çorum Erol Olçok Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
      • Yenimahalle / Ankara、土耳其(türkiye)、06170
        • 招聘中
        • Ankara Etlik Şehir Hastanesi-Göğüs Hastalıkları
      • Yuregir/Adana、土耳其(türkiye)、01060
        • 招聘中
        • Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye
      • Yıldırım/Bursa、土耳其(türkiye)、16310
        • 招聘中
        • Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
      • Zeytinburnu/İstanbul、土耳其(türkiye)、34020
        • 招聘中
        • Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi
      • Bochum、德国、44787
        • 招聘中
        • Siteworks GmbH Bochum
      • Hamburg、德国、22607
        • 招聘中
        • Wendisch - Dahl Hamburg - DZHW
      • Hanover、德国、30449
        • 招聘中
        • Siteworks GmbH Hannover
      • Karlsruhe、德国、76137
        • 招聘中
        • Siteworks GmbH Karlsruhe
      • Münster、德国、48145
        • 招聘中
        • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
      • Schleswig、德国、24837
        • 招聘中
        • Siteworks GmbH - Prüfzentrum Schleswig | RespiRatio
      • Fukuoka、日本、814-0180
        • 招聘中
        • Fukuoka University Hospital_Respiratory Medicine
      • Hiroshima、日本、730-0051
        • 招聘中
        • Chatani NeuroSleep Clinic_Neurology
      • Kumamoto、日本、862-0954
        • 招聘中
        • Kuwamizu Hospital_Internal Medicine
      • Okinawa、日本、901-2132
        • 招聘中
        • Nakamura Clinic_Pulmonology
      • Osaka、日本、532-0003
        • 招聘中
        • Osaka Kaisei Hospital_Sleep Medical Center
      • Sapporo-shi, Hokkaido、日本、062-0931
        • 招聘中
        • KKR Sappro Medical Center_Respiratory Medicine
      • Shizuoka、日本、436-8555
        • 招聘中
        • Chutoen General Medical Center_Neurology
      • Tokyo、日本、103-0027
        • 招聘中
        • Tokyo-Eki Center-building Clinic_Internal Medicine
      • Tokyo、日本、193-0811
        • 招聘中
        • Tokyo Tenshi Hospital_Internal medicine
      • Tokyo、日本、113-8431
        • 招聘中
        • Juntendo University Hospital_Cardiovascular Biology And Medicine
      • Gdansk、波兰、80-214
        • 招聘中
        • Uniwersyteckie Centrum Kliniczne
      • Gdansk、波兰、80-546
        • 招聘中
        • Penta Hospitals Badania Kliniczne Sp. z o.o.
      • Krakow、波兰、31-202
        • 完全的
        • Krakowski Szpital Specjalistyczny im. Jana Pawla II
      • Krakow、波兰、30-901
        • 招聘中
        • 5 Wojskowy Szpital Kliniczny z Polikliniką-Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie
      • Poznan、波兰、60-569
        • 招聘中
        • Uniwersytecki Szpital Kliniczny W Poznaniu
      • Warsaw、波兰、02-507
        • 招聘中
        • Państwowy Instytut Medyczny MSWiA
      • Warsaw、波兰、02-677
        • 招聘中
        • ETG Warszawa Sp. z o.o.
      • Warsaw、波兰、01-138
        • 招聘中
        • National Institute Of Tuberculosis And Lung Diseases - Instytut Gruźlicy i Chorób Płuc
      • Warsaw、波兰、00-124
        • 招聘中
        • Gyncentrum Sp. z o. o.
    • Dolnoslaskie Voivodeship
      • Wroclaw、Dolnoslaskie Voivodeship、波兰、50-981
        • 招聘中
        • 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
    • New South Wales
      • Macquarie Park、New South Wales、澳大利亚、2113
        • 招聘中
        • Woolcock Institute
    • Queensland
      • Birtinya、Queensland、澳大利亚、4575
        • 招聘中
        • University of Sunshine Coast - Vitality Village
      • South Brisbane、Queensland、澳大利亚、4101
        • 尚未招聘
        • Mater Research - RIO Clinical Trials Unit
    • South Australia
      • Adelaide、South Australia、澳大利亚、5000
        • 招聘中
        • Nightingale Research Adelaide
    • Western Australia
      • Crawley、Western Australia、澳大利亚、6009
        • 招聘中
        • University of Western Australia - Centre for Sleep Science
    • Arizona
      • Gilbert、Arizona、美国、85297
        • 招聘中
        • Dignity Health, Mercy Gilbert
    • Florida
      • Bradenton、Florida、美国、34209
        • 招聘中
        • DM Clinical
      • Naples、Florida、美国、34102
        • 招聘中
        • Essence MD Research
      • West Palm Beach、Florida、美国、33409
        • 招聘中
        • Palm Beach Research Center
    • Georgia
      • Atlanta、Georgia、美国、30328
        • 招聘中
        • NeuroTrials Research, Inc.
      • Lawrenceville、Georgia、美国、30046
        • 招聘中
        • Physicians Research Associates
    • Illinois
      • Chicago、Illinois、美国、60634
        • 招聘中
        • Chicago Research Center, Inc
    • New York
      • New York、New York、美国、10021
        • 招聘中
        • Weil Cornell Medicine
    • North Dakota
      • Fargo、North Dakota、美国、58104
        • 招聘中
        • Lillestol Research LLC
    • Ohio
      • Cincinnati、Ohio、美国、45212
        • 招聘中
        • CTI Clinical Research Center
    • Pennsylvania
      • DuBois、Pennsylvania、美国、15801
        • 尚未招聘
        • Clinical Research Associates of Central PA, LLC
    • South Carolina
      • Columbia、South Carolina、美国、29201
        • 招聘中
        • Bogan Sleep Consultants, LLC
    • Texas
      • DeSoto、Texas、美国、75115
        • 招聘中
        • Epic Medical Research
      • El Paso、Texas、美国、79912
        • 招聘中
        • Advanced Neurology Epilepsy and Sleep Center ANESC
      • El Paso、Texas、美国、79912
        • 招聘中
        • Biorhythms Center for Integrative Sleep Medicine
      • Houston、Texas、美国、77089
        • 招聘中
        • Houston Pulm Med Res Network
      • San Antonio、Texas、美国、78229
        • 招聘中
        • Sleep Therapy Research Center
      • Sugar Land、Texas、美国、77478
        • 招聘中
        • Tricoastal Sleep Center
    • Washington
      • Renton、Washington、美国、98057
        • 招聘中
        • Rainier Clin Res Ctr Inc
      • Seattle、Washington、美国、98104
        • 招聘中
        • Seattle Clinical Research Center
      • Barcelona、西班牙、08035
        • 招聘中
        • Hospital Vall d'hebrón
      • Castilleja de la Cuesta、西班牙、41950
        • 招聘中
        • Hospital Vithas Sevilla
      • Lleida、西班牙、25198
        • 招聘中
        • Hospital Univ. de Santa María de Lleida
      • Logroño、西班牙、26006
        • 招聘中
        • Hospital Universitario San Pedro
      • Madrid、西班牙、28034
        • 招聘中
        • Hospital Ramon y Cajal
      • Madrid、西班牙、28036
        • 招聘中
        • Instituto de Investigaciones del Sueño
      • Vitoria-Gasteiz、西班牙、01004
        • 招聘中
        • Hospital Universitario de Araba
    • Castille-La Mancha
      • Guadalajara、Castille-La Mancha、西班牙、19002
        • 招聘中
        • Hospital Universitario de Guadalajara
    • Madrid
      • Pozuelo de Alarcón、Madrid、西班牙、28223
        • 招聘中
        • H.U. Quirónsalud Madrid

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Key Inclusion Criteria:

  • Male or female (sex at birth)
  • Age 18 years or above at the time of signing informed consent
  • Previously diagnosed moderate-to-severe OSA with an AHI ≥ 15, as diagnosed with polysomnography (PSG), home sleep apnoea test (HSAT), or other method that meets local guidelines prior to screening

Key Exclusion Criteria:

  • Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening
  • History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records
  • Any planned or previous surgery within 90 days prior to screening for sleep apnoea, including septoplasty, turbinoplasty, or other ear, nose, and throat surgeries, including tonsillectomy and adenoidectomy
  • Significant craniofacial abnormalities that may affect breathing at baseline, for example Treacher Collins syndrome and Pierre Robin Sequence
  • Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonist (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较:安慰剂
参与者将每周一次皮下注射与NNC0487-0111匹配的安慰剂,作为低热量饮食和增加体力活动的辅助治疗。
与NNC0487-0111匹配的安慰剂将使用PDS290预充式笔式注射器,在以下身体部位之一进行皮下注射:大腿、腹部或上臂。
实验性的:NNC0487-0111
参与者将被随机分配接受两种剂量水平之一的NNC0487-0111皮下注射,每周一次,作为低热量饮食和增加体力活动的辅助治疗。
NNC0487-0111 将通过 PDS290 预填充笔式注射器皮下注射至以下身体部位之一:大腿、腹部或上臂。

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Relative change in body weight
大体时间:From baseline (week 0) to (week 80)
Measured as percentage (%) change in body weight.
From baseline (week 0) to (week 80)
Change in apnoea-hypopnoea index (AHI)
大体时间:From baseline (week 0) to (week 80)
Measured as events/hour.
From baseline (week 0) to (week 80)

次要结果测量

结果测量
措施说明
大体时间
腰围变化
大体时间:从基线(第0周)到(第80周)
以厘米(cm)为单位进行测量。
从基线(第0周)到(第80周)
收缩压(SBP)的变化
大体时间:从基线(第0周)到(第80周)
以毫米汞柱 (mmHg) 为单位测量。
从基线(第0周)到(第80周)
舒张压(DBP)的变化
大体时间:从基线(第 0 周)至(第 80 周)
测量单位为毫米汞柱。
从基线(第 0 周)至(第 80 周)
高敏C反应蛋白(hsCRP)的变化
大体时间:从基线(第0周)至(第80周)
以相对于基线的比值衡量。
从基线(第0周)至(第80周)
糖化血红蛋白(HbA1c)的变化
大体时间:从基线(第 0 周)到(第 80 周)
测量为HbA1c的百分比(%)。
从基线(第 0 周)到(第 80 周)
导致永久性治疗终止的TEAE数量
大体时间:从基线(第0周)至第84周
以事件衡量。
从基线(第0周)至第84周
Relative change in AHI
大体时间:From baseline (week 0) to (week 80)
Measured as percentage change in AHI.
From baseline (week 0) to (week 80)
Achievement of 50% reduction in AHI (Yes/No)
大体时间:From baseline (week 0) to (week 80)
Measured as number of participant.
From baseline (week 0) to (week 80)
Achievement of: AHI less than (<) 5
大体时间:From baseline (week 0) to (week 80)
Measured as number of participants.
From baseline (week 0) to (week 80)
Achievement of: AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No)
大体时间:From baseline (week 0) to (week 80)
Measured as number of participants.
From baseline (week 0) to (week 80)
Change in sleep apnoea specific hypoxic burden (SASHB)
大体时间:From baseline (week 0) to (week 80)
measured as %min/h (percentage minutes per hour).
From baseline (week 0) to (week 80)
Change in ESS score
大体时间:From baseline (week 0) to (week 80)
Measured as score on a scale. ESS measures the level of daytime sleepiness or average sleep propensity. The measure consists of 8 items yielding one total score. Total score ranges from 0-24. Higher scores indicate higher sleepiness or average sleep propensity in daily life.
From baseline (week 0) to (week 80)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score
大体时间:From baseline (week 0) to (week 80)
Measured as score on a scale. PROMIS-SRI measures perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakeful-ness associated with sleep problems or impaired alertness. The measure consists of 8 items each rated on a 5-point scale ranging from "not at all" to "very much". Individual item scores will be combined and converted to a T-score using a response pattern scoring approach. The T-score standardises the raw score to a distribution with a mean of 50 and standard deviation of 10. Total score (T-score range): Sleep-related impairment (ranging approximately from 30-80.1). Higher scores indicate more sleep-related impairment.
From baseline (week 0) to (week 80)
Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score
大体时间:From baseline (week 0) to (week 80)

Measured as score on a scale. PROMIS-SD measures perceptions of sleep quality, sleep depth, and restoration associated with sleep. The measure consists of 8 items each rated on a 5-point scale ranging from "not at all" to "very much," "never" to "always," or "very poor" to "very good". Individual item scores will be combined and converted to a T-score using a response pattern scoring approach. The T-score standardises the raw score to a distribution with a mean of 50 and standard deviation of 10. Total score (T-score range): Sleep disturbance (ranging approximately from 30-80.1).

Higher scores indicate more sleep disturbance.

From baseline (week 0) to (week 80)
Change in body weight
大体时间:From baseline (week 0) to (week 80)
Measured as kilogram (Kg).
From baseline (week 0) to (week 80)
Change in body mass index (BMI)
大体时间:From baseline (week 0) to (week 80)
Measured as kilograms per meter square (kg/m^2).
From baseline (week 0) to (week 80)
Improvement in obstructive sleep apnoea (OSA) severity category: AHI < 5/hour = normal (Yes/No)
大体时间:From baseline (week 0) to (week 80)
Measured as number of participants.
From baseline (week 0) to (week 80)
Improvement in OSA severity category: ≥ 5 and < 15/hour = mild (Yes/No)
大体时间:From baseline (week 0) to (week 80)
Measured as number of participants.
From baseline (week 0) to (week 80)
Improvement in OSA severity category: ≥ 15 and < 30/hour = moderate (Yes/No)
大体时间:From baseline (week 0) to (week 80)
Measured as number of participants.
From baseline (week 0) to (week 80)
Improvement in OSA severity category: ≥ 30/hour = severe (Yes/No)
大体时间:From baseline (week 0) to (week 80)
Measured as number of participants.
From baseline (week 0) to (week 80)
Withdrawal of positive airway pressure (PAP) therapy (Yes/No)
大体时间:From baseline (week 0) to (week 80)
Measured as number of participants.
From baseline (week 0) to (week 80)
Change in neck circumference
大体时间:From baseline (week 0) to (week 80)
Measured as cm.
From baseline (week 0) to (week 80)
Change in Total cholesterol
大体时间:From baseline (week 0) to (week 80)
Measured as ratio to baseline.
From baseline (week 0) to (week 80)
Change in High-density lipoprotein (HDL) cholesterol
大体时间:From baseline (week 0) to (week 80)
Measured as ratio to baseline.
From baseline (week 0) to (week 80)
Change in Low-density lipoprotein (LDL) cholesterol
大体时间:From baseline (week 0) to (week 80)
Measured as ratio to baseline.
From baseline (week 0) to (week 80)
Change in Very low-density lipoprotein (VLDL) cholesterol
大体时间:From baseline (week 0) to (week 80)
Measured as ratio to baseline.
From baseline (week 0) to (week 80)
Change in Non-HDL cholesterol
大体时间:From baseline (week 0) to (week 80)
Measured as ratio to baseline.
From baseline (week 0) to (week 80)
Change in Triglycerides
大体时间:From baseline (week 0) to (week 80)
Measured as ratio to baseline.
From baseline (week 0) to (week 80)
Change in fasting plasma glucose
大体时间:From baseline (week 0) to (week 80)
Measured as millimoles per litre (mmol/L).
From baseline (week 0) to (week 80)
Number of Treatment emergent adverse events (TEAEs)
大体时间:From baseline (week 0) to week 84
Measured as events.
From baseline (week 0) to week 84
Number of Treatment emergent serious adverse events (TESAEs)
大体时间:From baseline (week 0) to week 84
Measured as Events.
From baseline (week 0) to week 84

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Clinical Transparency dept. 2834、Novo Nordisk A/S

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月5日

初级完成 (估计的)

2028年6月26日

研究完成 (估计的)

2028年8月21日

研究注册日期

首次提交

2026年4月30日

首先提交符合 QC 标准的

2026年4月30日

首次发布 (实际的)

2026年5月6日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月8日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • NN9490-8293
  • U1111-1313-6538 (其他标识符:World Health Organization (WHO))
  • 2024-520443-16 (其他标识符:European Medical Agency (EMA))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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