NCT07571109RecruitingPhase 3
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
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)
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 30 Apr 2026
- Start date
- 5 May 2026
- Primary completion date
- 26 Jun 2028
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Obesity
- NCT number
- NCT07571109
- EU CT number
- 2024-520443-16-00
- EudraCT number
- 2024-520443-16
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 300
- From 5 May 2026 to the primary completion date, 26 Jun 2028
- 91 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records
- Significant craniofacial abnormalities that may affect breathing at baseline, for example Treacher Collins syndrome and Pierre Robin Sequence
Lab values
- Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (91)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nightingale Research Adelaide Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| University of Sunshine Coast - Vitality Village Coordinator of this site? Confirm its status | Birtinya | Australia | Recruiting |
| University of Western Australia - Centre for Sleep Science Coordinator of this site? Confirm its status | Crawley | Australia | Recruiting |
| Woolcock Institute Coordinator of this site? Confirm its status | Macquarie Park | Australia | Recruiting |
| Mater Research - RIO Clinical Trials Unit Coordinator of this site? Confirm its status | South Brisbane | Australia | Not yet recruiting |
| Peking University People's Hospital-Endocrinology Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Nanfang Hospital, Southern Medical University-Department of Psychiatry and Psychology Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology Coordinator of this site? Confirm its status | Luoyang | China | Not yet recruiting |
| The Second Affiliated Hospital of Nanjing Medical University-Endocrinology Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Shenzhen People's Hospital-Sleep Medicine Department Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| Tianjin Medical University General Hospital-Respiratory Coordinator of this site? Confirm its status | Tianjin | China | Not yet recruiting |
| Siteworks GmbH Coordinator of this site? Confirm its status | Bochum | Germany | Recruiting |
| Diabeteszentrum Hamburg West (DZHW) Gemeinschaftspraxis Dr. Wendisch, Dr. Dahl und Prof. Dr. Aberle Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Siteworks GmbH Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| Siteworks GmbH Coordinator of this site? Confirm its status | Karlsruhe | Germany | Recruiting |
| Institut fuer Diabetesforschung Muenster GmbH Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| Siteworks GmbH Coordinator of this site? Confirm its status | Schleswig | Germany | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Nisa Sevilla Aljarafe Coordinator of this site? Confirm its status | Castilleja De La Cuesta | Spain | Recruiting |
| Hospital Universitario De Guadalajara SESCAM Coordinator of this site? Confirm its status | Guadalajara | Spain | Recruiting |
| Hospital Universitari de Santa Maria Coordinator of this site? Confirm its status | Lleida | Spain | Recruiting |
| Hospital San Pedro Coordinator of this site? Confirm its status | Logroño | Spain | Recruiting |
| Instituto De Investigaciones Del Sueno S.L. Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Recruiting |
| Asociacion Instituto De Investigacion Sanitaria Bioaraba Coordinator of this site? Confirm its status | Vitoria | Spain | Recruiting |
| Rajarajeswari Medical College and Hospital Coordinator of this site? Confirm its status | Bengaluru | India | Recruiting |
| All India Institute of Medical Sciences (AIIMS) - Bhubaneswar Coordinator of this site? Confirm its status | Bhubaneswar | India | Not yet recruiting |
| All India Institute of Medical Sciences-Delhi Coordinator of this site? Confirm its status | Delhi | India | Recruiting |
| Guntur Government medical College Coordinator of this site? Confirm its status | Guntur | India | Completed |
| Yashoda Hospital Coordinator of this site? Confirm its status | Hyderabad | India | Completed |
| Asthma Bhawan Coordinator of this site? Confirm its status | Jaipur | India | Recruiting |
| Amrita Institute of Medical Sciences & Research Centre Coordinator of this site? Confirm its status | Kochi | India | Recruiting |
| Apollo Multispeciality Hospital, Kolkata Coordinator of this site? Confirm its status | Kolkata | India | Recruiting |
| Midland Healthcare & Research Center Coordinator of this site? Confirm its status | Lucknow | India | Recruiting |
| Bhaktivedanta Hospital & Research Institute Coordinator of this site? Confirm its status | Mumbai | India | Recruiting |
| Asian Kidney Hospital and Medical Centre Coordinator of this site? Confirm its status | Nagpur | India | Recruiting |
| Vardhaman Mahavir Medical College & Safdarjung Hospital Coordinator of this site? Confirm its status | New Delhi | India | Recruiting |
| Government Siddhartha Medical College & Government General Hospital, Vijayawada Coordinator of this site? Confirm its status | Vijayawada | India | Recruiting |
| Fukuoka University Hospital_Respiratory Medicine Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| Chatani NeuroSleep Clinic_Neurology Coordinator of this site? Confirm its status | Hiroshima | Japan | Recruiting |
| Kuwamizu Hospital_Internal Medicine Coordinator of this site? Confirm its status | Kumamoto | Japan | Recruiting |
| Nakamura Clinic_Pulmonology Coordinator of this site? Confirm its status | Okinawa | Japan | Recruiting |
| Osaka Kaisei Hospital_Sleep Medical Center Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| KKR Sappro Medical Center_Respiratory Medicine Coordinator of this site? Confirm its status | Sapporo-shi, Hokkaido | Japan | Recruiting |
| Chutoen General Medical Center_Neurology Coordinator of this site? Confirm its status | Shizuoka | Japan | Recruiting |
| Juntendo University Hospital_Cardiovascular Biology And Medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Tokyo Tenshi Hospital_Internal medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Tokyo-Eki Center-building Clinic_Internal Medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| 5 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Centrum Badan Klinicznych PI-House sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Etg Warszawa Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| National Institute Of Tuberculosis And Lung Diseases Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Gyncentrum Sp. z o. o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Ditmanson Medical Foundation Chia-Yi Christian Hospital Coordinator of this site? Confirm its status | Chiayi City | Taiwan | Not yet recruiting |
| Cathay General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Taipei Medical University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Chang Gung Memorial Hospital, Linkou Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Recruiting |
| NeuroTrials Research Inc Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| DM Clinical Coordinator of this site? Confirm its status | Bradenton | United States | Recruiting |
| Chicago Research Center Inc. Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| CTI Clinical Research Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Bogan Sleep Consultants, LLC Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| Epic Medical Research Coordinator of this site? Confirm its status | DeSoto | United States | Recruiting |
| Clinical Research Associates of Central Pa, LLC Coordinator of this site? Confirm its status | DuBois | United States | Not yet recruiting |
| Advanced Neurology Epilepsy and Sleep Center ANESC Coordinator of this site? Confirm its status | El Paso | United States | Recruiting |
| Biorhythms Center for Integrative Sleep Medicine Coordinator of this site? Confirm its status | El Paso | United States | Recruiting |
| Lillestol Research, LLC Coordinator of this site? Confirm its status | Fargo | United States | Recruiting |
| Dignity Health, Mercy Gilbert Coordinator of this site? Confirm its status | Gilbert | United States | Recruiting |
| Houston Pulm Med Res Network Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Physicians Research Associates Coordinator of this site? Confirm its status | Lawrenceville | United States | Recruiting |
| Essence MD Research Coordinator of this site? Confirm its status | Naples | United States | Recruiting |
| Weil Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Rainier Clin Res Ctr Inc Coordinator of this site? Confirm its status | Renton | United States | Recruiting |
| Sleep Therapy Research Center Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Seattle Clinical Research Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Tricoastal Sleep Center Coordinator of this site? Confirm its status | Sugar Land | United States | Recruiting |
| Palm Beach Research Center Coordinator of this site? Confirm its status | West Palm Beach | United States | Recruiting |
| T.C. Sağlık Bakanlığı Alaaddin Keykubat Üniversitesi Alanya Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları Coordinator of this site? Confirm its status | Alanya/ Antalya | Turkey (Türkiye) | Recruiting |
| İstanbul İl Sağlik Müdürlüğü Süreyyapaşa Göğüs Hastaliklari Ve Göğüs Cerrahisi Eğitim Ve Araştirma Hastanesi Coordinator of this site? Confirm its status | Maltepe/İstanbull | Turkey (Türkiye) | Recruiting |
| İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları Coordinator of this site? Confirm its status | Merkez/Battalgazi/Malatya | Turkey (Türkiye) | Recruiting |
| Hitit Üniversitesi Çorum Erol Olçok Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları Coordinator of this site? Confirm its status | Merkez/Çorum | Turkey (Türkiye) | Recruiting |
| Ankara Etlik Şehir Hastanesi-Göğüs Hastalıkları Coordinator of this site? Confirm its status | Yenimahalle / Ankara | Turkey (Türkiye) | Recruiting |
| Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları Coordinator of this site? Confirm its status | Yıldırım/Bursa | Turkey (Türkiye) | Recruiting |
| Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye Coordinator of this site? Confirm its status | Yuregir/Adana | Turkey (Türkiye) | Recruiting |
| Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi Coordinator of this site? Confirm its status | Zeytinburnu/İstanbul | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.