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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
Sponsor: Novo Nordisk A/S
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-05-05
Completion Date
2028-07-24
Last Updated
2026-05-06
Healthy Volunteers
No
Interventions
NNC0487-0111
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Placebo (matched to NNC0487-0111)
Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Locations (90)
Dignity Health, Mercy Gilbert
Gilbert, Arizona, United States
DM Clinical
Bradenton, Florida, United States
Essence MD Research
Naples, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
NeuroTrials Research, Inc.
Atlanta, Georgia, United States
Physicians Research Associates
Lawrenceville, Georgia, United States
Chicago Research Center, Inc
Chicago, Illinois, United States
Weil Cornell Medicine
New York, New York, United States
Lillestol Research LLC
Fargo, North Dakota, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Clinical Research Associates of Central PA, LLC
DuBois, Pennsylvania, United States
Bogan Sleep Consultants, LLC
Columbia, South Carolina, United States
Epic Medical Research
DeSoto, Texas, United States
Advanced Neurology Epilepsy and Sleep Center ANESC
El Paso, Texas, United States
Biorhythms Center for Integrative Sleep Medicine
El Paso, Texas, United States
Houston Pulmonary Medicine Associates, PA
Houston, Texas, United States
Sleep Therapy Research Center
San Antonio, Texas, United States
Tricoastal Sleep Center
Sugar Land, Texas, United States
Rainier Clin Res Ctr Inc
Renton, Washington, United States
Seattle Clinical Research Center
Seattle, Washington, United States
Woolcock Institute
Macquarie Park, New South Wales, Australia
University of Sunshine Coast - Vitality Village
Birtinya, Queensland, Australia
Mater Research - RIO Clinical Trials Unit
South Brisbane, Queensland, Australia
Nightingale Research
Adelaide, South Australia, Australia
University of Western Australia - Centre for Sleep Science
Crawley, Western Australia, Australia
Peking University People's Hospital-Endocrinology
Beijing, Beijing Municipality, China
Shenzhen People's Hospital-Sleep Medicine Department
Shenzhen, Guangdong, China
The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology
Luoyang, Henan, China
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
Nanjing, Jiangsu, China
Siteworks GmbH Bochum
Bochum, Germany
Wendisch - Dahl Hamburg - DZHW
Hamburg, Germany
Siteworks GmbH Hannover
Hanover, Germany
Siteworks GmbH Karlsruhe
Karlsruhe, Germany
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
Münster, Germany
Siteworks GmbH - Prüfzentrum Schleswig | RespiRatio
Schleswig, Germany
Guntur Government medical College
Guntur, Andhra Pradesh, India
Government Siddhartha Medical College & Government General Hospital, Vijayawada
Vijayawada, Andhra Pradesh, India
Rajarajeswari Medical College and Hospital
Bengaluru, Karnataka, India
Amrita Institute Of Medical Sciences & Research Centre
Kochi, Kerala, India
Bhaktivedanta Hospital & Research Institute
Mumbai, Maharashtra, India
Asian Kidney Hospital And Medical Centre
Nagpur, Maharashtra, India
Vardhaman Mahavir Medical College & Safdarjung Hospital
New Delhi, National Capital Territory of Delhi, India
All India Institute of Medical Sciences_Delhi
Delhi, New Delhi, India
All India Institute of Medical Sciences (AIIMS), Bhubaneswar
Bhubaneswar, Odisha, India
Yashoda Hospital
Hyderabad, Telangana, India
Midland Healthcare & Research Center
Lucknow, Uttar Pradesh, India
Apollo Multispeciality Hospital, Kolkata
Kolkata, West Bengal, India
Asthma Bhawan
Jaipur, India
Fukuoka University Hospital_Respiratory Medicine
Fukuoka, Japan
Chatani NeuroSleep Clinic_Neurology
Hiroshima, Japan
Kuwamizu Hospital_Internal Medicine
Kumamoto, Japan
Nakamura Clinic_Pulmonology
Okinawa, Japan
Osaka Kaisei Hospital_Sleep Medical Center
Osaka, Japan
KKR Sappro Medical Center_Respiratory Medicine
Sapporo-shi, Hokkaido, Japan
Chutoen General Medical Center_Neurology
Shizuoka, Japan
Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, Japan
Juntendo University Hospital_Cardiovascular Biology And Medicine
Tokyo, Japan
Tokyo Tenshi Hospital_Internal medicine
Tokyo, Japan
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
Wroclaw, Dolnoslaskie Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdansk, Poland
5 Wojskowy Szpital Kliniczny z Polikliniką-Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie
Krakow, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, Poland
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan, Poland
Gyncentrum Sp. z o. o.
Warsaw, Poland
National Institute Of Tuberculosis And Lung Diseases - Instytut Gruźlicy i Chorób Płuc
Warsaw, Poland
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
Warsaw, Poland
ETG Warszawa Sp. z o.o.
Warsaw, Poland
Hospital Universitario de Guadalajara
Guadalajara, Castille-La Mancha, Spain
H.U. Quirónsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Vall d'Hebron
Barcelona, Spain
Hospital Vithas Sevilla
Castilleja de la Cuesta, Spain
Hospital Univ. de Santa María de Lleida
Lleida, Spain
Hospital Universitario San Pedro
Logroño, Spain
Hospital Ramón y Cajal
Madrid, Spain
Instituto de Investigaciones del Sueño
Madrid, Spain
Hospital Universitario de Araba
Vitoria-Gasteiz, Spain
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City, Taiwan
Cathay General Hospital
Taipei, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan
T.C. Sağlık Bakanlığı Alaaddin Keykubat Üniversitesi Alanya Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
Alanya/ Antalya, Turkey (Türkiye)
İstanbul İl Sağlik Müdürlüğü Süreyyapaşa Göğüs Hastaliklari Ve Göğüs Cerrahisi Eğitim Ve Araştirma Hastanesi
Maltepe/İstanbull, Turkey (Türkiye)
İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları
Merkez/Battalgazi/Malatya, Turkey (Türkiye)
Hitit Üniversitesi Çorum Erol Olçok Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
Merkez/Çorum, Turkey (Türkiye)
Ankara Etlik Şehir Hastanesi-Göğüs Hastalıkları
Yenimahalle / Ankara, Turkey (Türkiye)
Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye
Yuregir/Adana, Turkey (Türkiye)
Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
Yıldırım/Bursa, Turkey (Türkiye)
Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi
Zeytinburnu/İstanbul, Turkey (Türkiye)