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RECRUITING Phase 3 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT07571109

Registry updated: 2026-10-07
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Description

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.

Interventions

  • NNC0487-0111 (Drug)
    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) (Drug)
    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.

Eligibility criteria

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

Conditions

Obesity Overweight Obstructive Sleep Apnoea

Locations

  • 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 Pulm Med Res Network — 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 — 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
  • Nanfang Hospital, Southern Medical University-Department of Psychiatry and Psychology — Guangzhou, Guangdong, 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
  • Tianjin Medical University General Hospital-Respiratory — Tianjin, Tianjin Municipality, 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
  • Penta Hospitals Badania Kliniczne 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)
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record