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)
Status: Recruiting
Location: See all (91) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Dignity Health, Mercy Gilbert
RECRUITING
Gilbert
Florida
DM Clinical
RECRUITING
Bradenton
Essence MD Research
RECRUITING
Naples
Palm Beach Research Center
RECRUITING
West Palm Beach
Georgia
NeuroTrials Research, Inc.
RECRUITING
Atlanta
Physicians Research Associates
RECRUITING
Lawrenceville
Illinois
Chicago Research Center, Inc
RECRUITING
Chicago
North Dakota
Lillestol Research LLC
RECRUITING
Fargo
New York
Weil Cornell Medicine
NOT_YET_RECRUITING
New York
Ohio
CTI Clinical Research Center
RECRUITING
Cincinnati
Pennsylvania
Clinical Research Associates of Central PA, LLC
NOT_YET_RECRUITING
Dubois
South Carolina
Bogan Sleep Consultants, LLC
RECRUITING
Columbia
Texas
Epic Medical Research
RECRUITING
Desoto
Advanced Neurology Epilepsy and Sleep Center ANESC
RECRUITING
El Paso
Biorhythms Center for Integrative Sleep Medicine
RECRUITING
El Paso
Houston Pulmonary Medicine Associates, PA
RECRUITING
Houston
Sleep Therapy Research Center
RECRUITING
San Antonio
Tricoastal Sleep Center
RECRUITING
Sugar Land
Washington
Rainier Clin Res Ctr Inc
RECRUITING
Renton
Seattle Clinical Research Center
RECRUITING
Seattle
Other Locations
Australia
Nightingale Research
RECRUITING
Adelaide
University of Sunshine Coast - Vitality Village
RECRUITING
Birtinya
University of Western Australia - Centre for Sleep Science
RECRUITING
Crawley
Woolcock Institute
RECRUITING
Macquarie Park
Mater Research - RIO Clinical Trials Unit
NOT_YET_RECRUITING
South Brisbane
China
Peking University People's Hospital-Endocrinology
NOT_YET_RECRUITING
Beijing
The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology
NOT_YET_RECRUITING
Luoyang
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
NOT_YET_RECRUITING
Nanjing
Shenzhen People's Hospital-Sleep Medicine Department
NOT_YET_RECRUITING
Shenzhen
Tianjin Medical University General Hospital-Respiratory
NOT_YET_RECRUITING
Tianjin
Germany
Siteworks GmbH Bochum
RECRUITING
Bochum
Wendisch - Dahl Hamburg - DZHW
RECRUITING
Hamburg
Siteworks GmbH Hannover
RECRUITING
Hanover
Siteworks GmbH Karlsruhe
RECRUITING
Karlsruhe
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
RECRUITING
Münster
Siteworks GmbH - Prüfzentrum Schleswig | RespiRatio
RECRUITING
Schleswig
India
Rajarajeswari Medical College and Hospital
NOT_YET_RECRUITING
Bengaluru
All India Institute of Medical Sciences (AIIMS), Bhubaneswar
NOT_YET_RECRUITING
Bhubaneswar
All India Institute of Medical Sciences_Delhi
NOT_YET_RECRUITING
Delhi
Guntur Government medical College
COMPLETED
Guntur
Yashoda Hospital
COMPLETED
Hyderabad
Asthma Bhawan
NOT_YET_RECRUITING
Jaipur
Amrita Institute Of Medical Sciences & Research Centre
NOT_YET_RECRUITING
Kochi
Apollo Multispeciality Hospital, Kolkata
NOT_YET_RECRUITING
Kolkata
Midland Healthcare & Research Center
NOT_YET_RECRUITING
Lucknow
Bhaktivedanta Hospital & Research Institute
NOT_YET_RECRUITING
Mumbai
Asian Kidney Hospital And Medical Centre
NOT_YET_RECRUITING
Nagpur
Vardhaman Mahavir Medical College & Safdarjung Hospital
NOT_YET_RECRUITING
New Delhi
Government Siddhartha Medical College & Government General Hospital, Vijayawada
NOT_YET_RECRUITING
Vijayawada
Japan
Fukuoka University Hospital_Respiratory Medicine
NOT_YET_RECRUITING
Fukuoka
Chatani NeuroSleep Clinic_Neurology
RECRUITING
Hiroshima
Kuwamizu Hospital_Internal Medicine
RECRUITING
Kumamoto
Nakamura Clinic_Pulmonology
RECRUITING
Okinawa
Osaka Kaisei Hospital_Sleep Medical Center
RECRUITING
Osaka
KKR Sappro Medical Center_Respiratory Medicine
RECRUITING
Sapporo-shi, Hokkaido
Chutoen General Medical Center_Neurology
RECRUITING
Shizuoka
Juntendo University Hospital_Cardiovascular Biology And Medicine
NOT_YET_RECRUITING
Tokyo
Tokyo Tenshi Hospital_Internal medicine
RECRUITING
Tokyo
Tokyo-Eki Center-building Clinic_Internal Medicine
RECRUITING
Tokyo
Poland
Centrum Badan Klinicznych PI-House Sp. z o.o.
RECRUITING
Gdansk
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
5 Wojskowy Szpital Kliniczny z Polikliniką-Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie
NOT_YET_RECRUITING
Krakow
Krakowski Szpital Specjalistyczny im. Jana Pawla II
COMPLETED
Krakow
Uniwersytecki Szpital Kliniczny W Poznaniu
RECRUITING
Poznan
ETG Warszawa Sp. z o.o.
RECRUITING
Warsaw
Gyncentrum Sp. z o. o.
NOT_YET_RECRUITING
Warsaw
National Institute Of Tuberculosis And Lung Diseases - Instytut Gruźlicy i Chorób Płuc
NOT_YET_RECRUITING
Warsaw
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
RECRUITING
Warsaw
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
RECRUITING
Wroclaw
Spain
Hospital Vall d'Hebron
NOT_YET_RECRUITING
Barcelona
Hospital Vithas Sevilla
RECRUITING
Castilleja De La Cuesta
Hospital Universitario de Guadalajara
RECRUITING
Guadalajara
Hospital Univ. de Santa María de Lleida
RECRUITING
Lleida
Hospital Universitario San Pedro
RECRUITING
Logroño
Hospital Ramón y Cajal
RECRUITING
Madrid
Instituto de Investigaciones del Sueño
RECRUITING
Madrid
H.U. Quirónsalud Madrid
RECRUITING
Pozuelo De Alarcón
Hospital Universitario de Araba
RECRUITING
Vitoria-gasteiz
Taiwan
Ditmanson Medical Foundation Chia-Yi Christian Hospital
NOT_YET_RECRUITING
Chiayi City
Cathay General Hospital
NOT_YET_RECRUITING
Taipei
Taipei Medical University Hospital
NOT_YET_RECRUITING
Taipei
Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology
NOT_YET_RECRUITING
Taipei
Chang Gung Memorial Hospital, Linkou
NOT_YET_RECRUITING
Taoyuan
Turkey
T.C. Sağlık Bakanlığı Alaaddin Keykubat Üniversitesi Alanya Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
NOT_YET_RECRUITING
Alanya/ Antalya
İstanbul İl Sağlik Müdürlüğü Süreyyapaşa Göğüs Hastaliklari Ve Göğüs Cerrahisi Eğitim Ve Araştirma Hastanesi
RECRUITING
Maltepe/i̇stanbull
İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları
RECRUITING
Merkez/battalgazi/malatya
Hitit Üniversitesi Çorum Erol Olçok Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
RECRUITING
Merkez/çorum
Ankara Etlik Şehir Hastanesi-Göğüs Hastalıkları
RECRUITING
Yenimahalle / Ankara
Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
RECRUITING
Yıldırım/bursa
Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye
RECRUITING
Yuregir/adana
Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi
RECRUITING
Zeytinburnu/i̇stanbul
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2026-05-05
Estimated Completion Date: 2028-08-21
Participants
Target number of participants: 300
Treatments
Experimental: NNC0487-0111
Participants will be randomized to receive 1 of the 2 dose levels of NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Placebo_comparator: Placebo
Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S