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)
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)
研究概览
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名:Novo Nordisk
- 电话号码:(+1) 866-867-7178
- 邮箱:clinicaltrials@novonordisk.com
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
-
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
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
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
调查人员
- 研究主任:Clinical Transparency dept. 2834、Novo Nordisk A/S
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 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)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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