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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

Full criteria on ClinicalTrials.gov

Sites (91)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nightingale Research Adelaide
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AdelaideAustraliaRecruiting
University of Sunshine Coast - Vitality Village
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BirtinyaAustraliaRecruiting
University of Western Australia - Centre for Sleep Science
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CrawleyAustraliaRecruiting
Woolcock Institute
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Macquarie ParkAustraliaRecruiting
Mater Research - RIO Clinical Trials Unit
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South BrisbaneAustraliaNot yet recruiting
Peking University People's Hospital-Endocrinology
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BeijingChinaRecruiting
Nanfang Hospital, Southern Medical University-Department of Psychiatry and Psychology
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GuangzhouChinaNot yet recruiting
The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology
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LuoyangChinaNot yet recruiting
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
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NanjingChinaRecruiting
Shenzhen People's Hospital-Sleep Medicine Department
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ShenzhenChinaRecruiting
Tianjin Medical University General Hospital-Respiratory
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TianjinChinaNot yet recruiting
Siteworks GmbH
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BochumGermanyRecruiting
Diabeteszentrum Hamburg West (DZHW) Gemeinschaftspraxis Dr. Wendisch, Dr. Dahl und Prof. Dr. Aberle
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HamburgGermanyRecruiting
Siteworks GmbH
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HanoverGermanyRecruiting
Siteworks GmbH
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KarlsruheGermanyRecruiting
Institut fuer Diabetesforschung Muenster GmbH
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MuensterGermanyRecruiting
Siteworks GmbH
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SchleswigGermanyRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Nisa Sevilla Aljarafe
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Castilleja De La CuestaSpainRecruiting
Hospital Universitario De Guadalajara SESCAM
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GuadalajaraSpainRecruiting
Hospital Universitari de Santa Maria
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LleidaSpainRecruiting
Hospital San Pedro
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LogroñoSpainRecruiting
Instituto De Investigaciones Del Sueno S.L.
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainRecruiting
Asociacion Instituto De Investigacion Sanitaria Bioaraba
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VitoriaSpainRecruiting
Rajarajeswari Medical College and Hospital
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BengaluruIndiaRecruiting
All India Institute of Medical Sciences (AIIMS) - Bhubaneswar
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BhubaneswarIndiaNot yet recruiting
All India Institute of Medical Sciences-Delhi
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DelhiIndiaRecruiting
Guntur Government medical College
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GunturIndiaCompleted
Yashoda Hospital
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HyderabadIndiaCompleted
Asthma Bhawan
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JaipurIndiaRecruiting
Amrita Institute of Medical Sciences & Research Centre
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KochiIndiaRecruiting
Apollo Multispeciality Hospital, Kolkata
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KolkataIndiaRecruiting
Midland Healthcare & Research Center
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LucknowIndiaRecruiting
Bhaktivedanta Hospital & Research Institute
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MumbaiIndiaRecruiting
Asian Kidney Hospital and Medical Centre
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NagpurIndiaRecruiting
Vardhaman Mahavir Medical College & Safdarjung Hospital
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New DelhiIndiaRecruiting
Government Siddhartha Medical College & Government General Hospital, Vijayawada
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VijayawadaIndiaRecruiting
Fukuoka University Hospital_Respiratory Medicine
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FukuokaJapanRecruiting
Chatani NeuroSleep Clinic_Neurology
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HiroshimaJapanRecruiting
Kuwamizu Hospital_Internal Medicine
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KumamotoJapanRecruiting
Nakamura Clinic_Pulmonology
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OkinawaJapanRecruiting
Osaka Kaisei Hospital_Sleep Medical Center
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OsakaJapanRecruiting
KKR Sappro Medical Center_Respiratory Medicine
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Sapporo-shi, HokkaidoJapanRecruiting
Chutoen General Medical Center_Neurology
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ShizuokaJapanRecruiting
Juntendo University Hospital_Cardiovascular Biology And Medicine
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TokyoJapanRecruiting
Tokyo Tenshi Hospital_Internal medicine
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TokyoJapanRecruiting
Tokyo-Eki Center-building Clinic_Internal Medicine
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TokyoJapanRecruiting
5 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Krakowie
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CracowPolandRecruiting
Centrum Badan Klinicznych PI-House sp. z o.o.
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GdanskPolandRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandRecruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandRecruiting
Etg Warszawa Sp. z o.o.
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WarsawPolandRecruiting
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
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WarsawPolandRecruiting
National Institute Of Tuberculosis And Lung Diseases
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WarsawPolandRecruiting
Gyncentrum Sp. z o. o.
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WarsawPolandRecruiting
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
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WroclawPolandRecruiting
Ditmanson Medical Foundation Chia-Yi Christian Hospital
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Chiayi CityTaiwanNot yet recruiting
Cathay General Hospital
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TaipeiTaiwanRecruiting
Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology
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TaipeiTaiwanRecruiting
Taipei Medical University Hospital
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TaipeiTaiwanRecruiting
Chang Gung Memorial Hospital, Linkou
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TaoyuanTaiwanRecruiting
NeuroTrials Research Inc
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AtlantaUnited StatesRecruiting
DM Clinical
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BradentonUnited StatesRecruiting
Chicago Research Center Inc.
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ChicagoUnited StatesRecruiting
CTI Clinical Research Center
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CincinnatiUnited StatesRecruiting
Bogan Sleep Consultants, LLC
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ColumbiaUnited StatesRecruiting
Epic Medical Research
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DeSotoUnited StatesRecruiting
Clinical Research Associates of Central Pa, LLC
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DuBoisUnited StatesNot yet recruiting
Advanced Neurology Epilepsy and Sleep Center ANESC
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El PasoUnited StatesRecruiting
Biorhythms Center for Integrative Sleep Medicine
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El PasoUnited StatesRecruiting
Lillestol Research, LLC
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FargoUnited StatesRecruiting
Dignity Health, Mercy Gilbert
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GilbertUnited StatesRecruiting
Houston Pulm Med Res Network
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HoustonUnited StatesRecruiting
Physicians Research Associates
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LawrencevilleUnited StatesRecruiting
Essence MD Research
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NaplesUnited StatesRecruiting
Weil Cornell Medicine
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New YorkUnited StatesRecruiting
Rainier Clin Res Ctr Inc
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RentonUnited StatesRecruiting
Sleep Therapy Research Center
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San AntonioUnited StatesRecruiting
Seattle Clinical Research Center
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SeattleUnited StatesRecruiting
Tricoastal Sleep Center
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Sugar LandUnited StatesRecruiting
Palm Beach Research Center
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West Palm BeachUnited StatesRecruiting
T.C. Sağlık Bakanlığı Alaaddin Keykubat Üniversitesi Alanya Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
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Alanya/ AntalyaTurkey (Türkiye)Recruiting
İstanbul İl Sağlik Müdürlüğü Süreyyapaşa Göğüs Hastaliklari Ve Göğüs Cerrahisi Eğitim Ve Araştirma Hastanesi
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Maltepe/İstanbullTurkey (Türkiye)Recruiting
İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları
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Merkez/Battalgazi/MalatyaTurkey (Türkiye)Recruiting
Hitit Üniversitesi Çorum Erol Olçok Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
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Merkez/ÇorumTurkey (Türkiye)Recruiting
Ankara Etlik Şehir Hastanesi-Göğüs Hastalıkları
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Yenimahalle / AnkaraTurkey (Türkiye)Recruiting
Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
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Yıldırım/BursaTurkey (Türkiye)Recruiting
Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye
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Yuregir/AdanaTurkey (Türkiye)Recruiting
Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi
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Zeytinburnu/İstanbulTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.