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 (AMAZE 4)
8 september 2026 uppdaterad av: Novo Nordisk A/S
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)
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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
300
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Novo Nordisk
- Telefonnummer: (+1) 866-867-7178
- E-post: clinicaltrials@novonordisk.com
Studieorter
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New South Wales
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Macquarie Park, New South Wales, Australien, 2113
- Rekrytering
- Woolcock Institute
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Queensland
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Birtinya, Queensland, Australien, 4575
- Rekrytering
- University of Sunshine Coast - Vitality Village
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South Brisbane, Queensland, Australien, 4101
- Har inte rekryterat ännu
- Mater Research - RIO Clinical Trials Unit
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South Australia
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Adelaide, South Australia, Australien, 5000
- Rekrytering
- Nightingale Research Adelaide
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Western Australia
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Crawley, Western Australia, Australien, 6009
- Rekrytering
- University of Western Australia - Centre for Sleep Science
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Arizona
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Gilbert, Arizona, Förenta staterna, 85297
- Rekrytering
- Dignity Health, Mercy Gilbert
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Florida
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Bradenton, Florida, Förenta staterna, 34209
- Rekrytering
- DM Clinical
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Naples, Florida, Förenta staterna, 34102
- Rekrytering
- Essence MD Research
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West Palm Beach, Florida, Förenta staterna, 33409
- Rekrytering
- Palm Beach Research Center
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Georgia
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Atlanta, Georgia, Förenta staterna, 30328
- Rekrytering
- NeuroTrials Research, Inc.
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Lawrenceville, Georgia, Förenta staterna, 30046
- Rekrytering
- Physicians Research Associates
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Illinois
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Chicago, Illinois, Förenta staterna, 60634
- Rekrytering
- Chicago Research Center, Inc
-
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New York
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New York, New York, Förenta staterna, 10021
- Rekrytering
- Weil Cornell Medicine
-
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North Dakota
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Fargo, North Dakota, Förenta staterna, 58104
- Rekrytering
- Lillestol Research LLC
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45212
- Rekrytering
- CTI Clinical Research Center
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Pennsylvania
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DuBois, Pennsylvania, Förenta staterna, 15801
- Har inte rekryterat ännu
- Clinical Research Associates of Central PA, LLC
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South Carolina
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Columbia, South Carolina, Förenta staterna, 29201
- Rekrytering
- Bogan Sleep Consultants, LLC
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Texas
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DeSoto, Texas, Förenta staterna, 75115
- Rekrytering
- Epic Medical Research
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El Paso, Texas, Förenta staterna, 79912
- Rekrytering
- Advanced Neurology Epilepsy and Sleep Center ANESC
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El Paso, Texas, Förenta staterna, 79912
- Rekrytering
- Biorhythms Center for Integrative Sleep Medicine
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Houston, Texas, Förenta staterna, 77089
- Rekrytering
- Houston Pulm Med Res Network
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San Antonio, Texas, Förenta staterna, 78229
- Rekrytering
- Sleep Therapy Research Center
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Sugar Land, Texas, Förenta staterna, 77478
- Rekrytering
- Tricoastal Sleep Center
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Washington
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Renton, Washington, Förenta staterna, 98057
- Rekrytering
- Rainier Clin Res Ctr Inc
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Seattle, Washington, Förenta staterna, 98104
- Rekrytering
- Seattle Clinical Research Center
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-
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Jaipur, Indien, 302039
- Rekrytering
- Asthma Bhawan
-
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Andhra Pradesh
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Guntur, Andhra Pradesh, Indien, 522004,
- Avslutad
- Guntur Government medical College
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Vijayawada, Andhra Pradesh, Indien, 520008
- Rekrytering
- Government Siddhartha Medical College & Government General Hospital, Vijayawada
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Karnataka
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Bengaluru, Karnataka, Indien, 560074
- Rekrytering
- Rajarajeswari Medical College and Hospital
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Kerala
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Kochi, Kerala, Indien, 682041
- Rekrytering
- Amrita Institute of Medical Sciences & Research Centre
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Maharashtra
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Mumbai, Maharashtra, Indien, 401107
- Rekrytering
- Bhaktivedanta Hospital & Research Institute
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Nagpur, Maharashtra, Indien, 440010
- Rekrytering
- Asian Kidney Hospital And Medical Centre
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, Indien, 110029
- Har inte rekryterat ännu
- Vardhaman Mahavir Medical College & Safdarjung Hospital
-
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New Delhi
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Delhi, New Delhi, Indien, 110029
- Rekrytering
- All India Institute of Medical Sciences_Delhi
-
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Odisha
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Bhubaneswar, Odisha, Indien, 751019
- Har inte rekryterat ännu
- All India Institute of Medical Sciences (AIIMS), Bhubaneswar
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Telangana
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Hyderabad, Telangana, Indien, 500084
- Avslutad
- Yashoda Hospital
-
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Uttar Pradesh
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Lucknow, Uttar Pradesh, Indien, 226006
- Rekrytering
- Midland Healthcare & Research Center
-
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West Bengal
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Kolkata, West Bengal, Indien, 700054
- Rekrytering
- Apollo Multispeciality Hospital, Kolkata
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-
-
-
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Fukuoka, Japan, 814-0180
- Rekrytering
- Fukuoka University Hospital_Respiratory Medicine
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Hiroshima, Japan, 730-0051
- Rekrytering
- Chatani NeuroSleep Clinic_Neurology
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Kumamoto, Japan, 862-0954
- Rekrytering
- Kuwamizu Hospital_Internal Medicine
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Okinawa, Japan, 901-2132
- Rekrytering
- Nakamura Clinic_Pulmonology
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Osaka, Japan, 532-0003
- Rekrytering
- Osaka Kaisei Hospital_Sleep Medical Center
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Sapporo-shi, Hokkaido, Japan, 062-0931
- Rekrytering
- KKR Sappro Medical Center_Respiratory Medicine
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Shizuoka, Japan, 436-8555
- Rekrytering
- Chutoen General Medical Center_Neurology
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Tokyo, Japan, 103-0027
- Rekrytering
- Tokyo-Eki Center-building Clinic_Internal Medicine
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Tokyo, Japan, 193-0811
- Rekrytering
- Tokyo Tenshi Hospital_Internal medicine
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Tokyo, Japan, 113-8431
- Rekrytering
- Juntendo University Hospital_Cardiovascular Biology And Medicine
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100044
- Rekrytering
- Peking University People's Hospital-Endocrinology
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Guangdong
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Guangzhou, Guangdong, Kina, 510515
- Har inte rekryterat ännu
- Nanfang Hospital, Southern Medical University-Department of Psychiatry and Psychology
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Shenzhen, Guangdong, Kina, 518020
- Har inte rekryterat ännu
- Shenzhen People's Hospital-Sleep Medicine Department
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Henan
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Luoyang, Henan, Kina, 471003
- Har inte rekryterat ännu
- The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology
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Jiangsu
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Nanjing, Jiangsu, Kina, 210011
- Rekrytering
- The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300052
- Har inte rekryterat ännu
- Tianjin Medical University General Hospital-Respiratory
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Gdansk, Polen, 80-214
- Rekrytering
- Uniwersyteckie Centrum Kliniczne
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Gdansk, Polen, 80-546
- Rekrytering
- Penta Hospitals Badania Kliniczne Sp. z o.o.
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Krakow, Polen, 31-202
- Avslutad
- Krakowski Szpital Specjalistyczny im. Jana Pawla II
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Krakow, Polen, 30-901
- Rekrytering
- 5 Wojskowy Szpital Kliniczny z Polikliniką-Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie
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Poznan, Polen, 60-569
- Rekrytering
- Uniwersytecki Szpital Kliniczny W Poznaniu
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Warsaw, Polen, 02-507
- Rekrytering
- Państwowy Instytut Medyczny MSWiA
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Warsaw, Polen, 02-677
- Rekrytering
- ETG Warszawa Sp. z o.o.
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Warsaw, Polen, 01-138
- Rekrytering
- National Institute Of Tuberculosis And Lung Diseases - Instytut Gruźlicy i Chorób Płuc
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Warsaw, Polen, 00-124
- Rekrytering
- Gyncentrum Sp. z o. o.
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Dolnoslaskie Voivodeship
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Wroclaw, Dolnoslaskie Voivodeship, Polen, 50-981
- Rekrytering
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
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Barcelona, Spanien, 08035
- Rekrytering
- Hospital Vall d'hebrón
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Castilleja de la Cuesta, Spanien, 41950
- Rekrytering
- Hospital Vithas Sevilla
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Lleida, Spanien, 25198
- Rekrytering
- Hospital Univ. de Santa María de Lleida
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Logroño, Spanien, 26006
- Rekrytering
- Hospital Universitario San Pedro
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Madrid, Spanien, 28034
- Rekrytering
- Hospital Ramon y Cajal
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Madrid, Spanien, 28036
- Rekrytering
- Instituto de Investigaciones del Sueño
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Vitoria-Gasteiz, Spanien, 01004
- Rekrytering
- Hospital Universitario de Araba
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Castille-La Mancha
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Guadalajara, Castille-La Mancha, Spanien, 19002
- Rekrytering
- Hospital Universitario de Guadalajara
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Madrid
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Pozuelo de Alarcón, Madrid, Spanien, 28223
- Rekrytering
- H.U. Quirónsalud Madrid
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Chiayi City, Taiwan, 600
- Har inte rekryterat ännu
- Ditmanson Medical Foundation Chia-Yi Christian Hospital
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Taipei, Taiwan, 110
- Rekrytering
- Taipei Medical University Hospital
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Taipei, Taiwan, 106
- Rekrytering
- Cathay General Hospital
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Taipei, Taiwan, 116
- Rekrytering
- Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology
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Taoyuan, Taiwan, 333
- Rekrytering
- Chang Gung Memorial Hospital, Linkou
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Alanya/ Antalya, Turkiet (Türkiye), 07400
- Rekrytering
- T.C. Sağlık Bakanlığı Alaaddin Keykubat Üniversitesi Alanya Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
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Maltepe/İstanbull, Turkiet (Türkiye), 34843
- Rekrytering
- İstanbul İl Sağlik Müdürlüğü Süreyyapaşa Göğüs Hastaliklari Ve Göğüs Cerrahisi Eğitim Ve Araştirma Hastanesi
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Merkez/Battalgazi/Malatya, Turkiet (Türkiye), 44280
- Rekrytering
- İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları
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Merkez/Çorum, Turkiet (Türkiye), 19040
- Rekrytering
- Hitit Üniversitesi Çorum Erol Olçok Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
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Yenimahalle / Ankara, Turkiet (Türkiye), 06170
- Rekrytering
- Ankara Etlik Şehir Hastanesi-Göğüs Hastalıkları
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Yuregir/Adana, Turkiet (Türkiye), 01060
- Rekrytering
- Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye
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Yıldırım/Bursa, Turkiet (Türkiye), 16310
- Rekrytering
- Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
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Zeytinburnu/İstanbul, Turkiet (Türkiye), 34020
- Rekrytering
- Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi
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Bochum, Tyskland, 44787
- Rekrytering
- Siteworks GmbH Bochum
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Hamburg, Tyskland, 22607
- Rekrytering
- Wendisch - Dahl Hamburg - DZHW
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Hanover, Tyskland, 30449
- Rekrytering
- Siteworks GmbH Hannover
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Karlsruhe, Tyskland, 76137
- Rekrytering
- Siteworks GmbH Karlsruhe
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Münster, Tyskland, 48145
- Rekrytering
- Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
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Schleswig, Tyskland, 24837
- Rekrytering
- Siteworks GmbH - Prüfzentrum Schleswig | RespiRatio
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Placebo-jämförare: Placebo
Deltagarna får placebo som matchar NNC0487-0111 subkutant en gång i veckan som ett komplement till en kalorireducerad kost och ökad fysisk aktivitet.
|
Placebo matchat till NNC0487-0111 kommer att administreras subkutant med PDS290 förfyllda pen-injektorer till en av kroppsdelarna: lår, mage eller överarm.
|
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Experimentell: NNC0487-0111
Deltagarna kommer att randomiseras att få en av de två dosnivåerna av NNC0487-0111 subkutant en gång i veckan som ett komplement till en kalorireducerad kost och ökad fysisk aktivitet.
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NNC0487-0111 kommer att administreras subkutant med PDS290 förfyllda peninjektorer till en av kroppsdelarna: lår, buk eller överarm.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Relative change in body weight
Tidsram: From baseline (week 0) to (week 80)
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Measured as percentage (%) change in body weight.
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From baseline (week 0) to (week 80)
|
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Change in apnoea-hypopnoea index (AHI)
Tidsram: From baseline (week 0) to (week 80)
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Measured as events/hour.
|
From baseline (week 0) to (week 80)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Förändring i midjeomfång
Tidsram: Från baslinje (vecka 0) till (vecka 80)
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Mätt i centimeter (cm).
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Från baslinje (vecka 0) till (vecka 80)
|
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Förändring i systoliskt blodtryck (SBP)
Tidsram: Från baseline (vecka 0) till (vecka 80)
|
Mätt som millimeter kvicksilver (mmHg).
|
Från baseline (vecka 0) till (vecka 80)
|
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Förändring i diastoliskt blodtryck (DBP)
Tidsram: Från baslinje (vecka 0) till (vecka 80)
|
Mätt i mmHg.
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Från baslinje (vecka 0) till (vecka 80)
|
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Förändring av högkänsligt C-reaktivt protein (hsCRP)
Tidsram: Från baslinje (vecka 0) till (vecka 80)
|
Mätt som förhållande till baslinjen.
|
Från baslinje (vecka 0) till (vecka 80)
|
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Förändring av glykosylerat hemoglobin (HbA1c)
Tidsram: Från baslinje (vecka 0) till (vecka 80)
|
Mäts i procent (%) av HbA1c.
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Från baslinje (vecka 0) till (vecka 80)
|
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Antal TEAEs som leder till permanent behandlingsavbrott
Tidsram: Från baseline (vecka 0) till vecka 84
|
Mätt som händelser.
|
Från baseline (vecka 0) till vecka 84
|
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Relative change in AHI
Tidsram: From baseline (week 0) to (week 80)
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Measured as percentage change in AHI.
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From baseline (week 0) to (week 80)
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Achievement of 50% reduction in AHI (Yes/No)
Tidsram: From baseline (week 0) to (week 80)
|
Measured as number of participant.
|
From baseline (week 0) to (week 80)
|
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Achievement of: AHI less than (<) 5
Tidsram: From baseline (week 0) to (week 80)
|
Measured as number of participants.
|
From baseline (week 0) to (week 80)
|
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Achievement of: AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No)
Tidsram: From baseline (week 0) to (week 80)
|
Measured as number of participants.
|
From baseline (week 0) to (week 80)
|
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Change in sleep apnoea specific hypoxic burden (SASHB)
Tidsram: From baseline (week 0) to (week 80)
|
measured as %min/h (percentage minutes per hour).
|
From baseline (week 0) to (week 80)
|
|
Change in ESS score
Tidsram: From baseline (week 0) to (week 80)
|
Measured as score on a scale.
ESS measures the level of daytime sleepiness or average sleep propensity.
The measure consists of 8 items yielding one total score.
Total score ranges from 0-24.
Higher scores indicate higher sleepiness or average sleep propensity in daily life.
|
From baseline (week 0) to (week 80)
|
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Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score
Tidsram: From baseline (week 0) to (week 80)
|
Measured as score on a scale.
PROMIS-SRI measures perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakeful-ness associated with sleep problems or impaired alertness.
The measure consists of 8 items each rated on a 5-point scale ranging from "not at all" to "very much".
Individual item scores will be combined and converted to a T-score using a response pattern scoring approach.
The T-score standardises the raw score to a distribution with a mean of 50 and standard deviation of 10.
Total score (T-score range): Sleep-related impairment (ranging approximately from 30-80.1).
Higher scores indicate more sleep-related impairment.
|
From baseline (week 0) to (week 80)
|
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Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score
Tidsram: From baseline (week 0) to (week 80)
|
Measured as score on a scale. PROMIS-SD measures perceptions of sleep quality, sleep depth, and restoration associated with sleep. The measure consists of 8 items each rated on a 5-point scale ranging from "not at all" to "very much," "never" to "always," or "very poor" to "very good". Individual item scores will be combined and converted to a T-score using a response pattern scoring approach. The T-score standardises the raw score to a distribution with a mean of 50 and standard deviation of 10. Total score (T-score range): Sleep disturbance (ranging approximately from 30-80.1). Higher scores indicate more sleep disturbance. |
From baseline (week 0) to (week 80)
|
|
Change in body weight
Tidsram: From baseline (week 0) to (week 80)
|
Measured as kilogram (Kg).
|
From baseline (week 0) to (week 80)
|
|
Change in body mass index (BMI)
Tidsram: From baseline (week 0) to (week 80)
|
Measured as kilograms per meter square (kg/m^2).
|
From baseline (week 0) to (week 80)
|
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Improvement in obstructive sleep apnoea (OSA) severity category: AHI < 5/hour = normal (Yes/No)
Tidsram: From baseline (week 0) to (week 80)
|
Measured as number of participants.
|
From baseline (week 0) to (week 80)
|
|
Improvement in OSA severity category: ≥ 5 and < 15/hour = mild (Yes/No)
Tidsram: From baseline (week 0) to (week 80)
|
Measured as number of participants.
|
From baseline (week 0) to (week 80)
|
|
Improvement in OSA severity category: ≥ 15 and < 30/hour = moderate (Yes/No)
Tidsram: From baseline (week 0) to (week 80)
|
Measured as number of participants.
|
From baseline (week 0) to (week 80)
|
|
Improvement in OSA severity category: ≥ 30/hour = severe (Yes/No)
Tidsram: From baseline (week 0) to (week 80)
|
Measured as number of participants.
|
From baseline (week 0) to (week 80)
|
|
Withdrawal of positive airway pressure (PAP) therapy (Yes/No)
Tidsram: From baseline (week 0) to (week 80)
|
Measured as number of participants.
|
From baseline (week 0) to (week 80)
|
|
Change in neck circumference
Tidsram: From baseline (week 0) to (week 80)
|
Measured as cm.
|
From baseline (week 0) to (week 80)
|
|
Change in Total cholesterol
Tidsram: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline.
|
From baseline (week 0) to (week 80)
|
|
Change in High-density lipoprotein (HDL) cholesterol
Tidsram: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline.
|
From baseline (week 0) to (week 80)
|
|
Change in Low-density lipoprotein (LDL) cholesterol
Tidsram: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline.
|
From baseline (week 0) to (week 80)
|
|
Change in Very low-density lipoprotein (VLDL) cholesterol
Tidsram: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline.
|
From baseline (week 0) to (week 80)
|
|
Change in Non-HDL cholesterol
Tidsram: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline.
|
From baseline (week 0) to (week 80)
|
|
Change in Triglycerides
Tidsram: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline.
|
From baseline (week 0) to (week 80)
|
|
Change in fasting plasma glucose
Tidsram: From baseline (week 0) to (week 80)
|
Measured as millimoles per litre (mmol/L).
|
From baseline (week 0) to (week 80)
|
|
Number of Treatment emergent adverse events (TEAEs)
Tidsram: From baseline (week 0) to week 84
|
Measured as events.
|
From baseline (week 0) to week 84
|
|
Number of Treatment emergent serious adverse events (TESAEs)
Tidsram: From baseline (week 0) to week 84
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Measured as Events.
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From baseline (week 0) to week 84
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Clinical Transparency dept. 2834, Novo Nordisk A/S
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
5 maj 2026
Primärt slutförande (Beräknad)
26 juni 2028
Avslutad studie (Beräknad)
21 augusti 2028
Studieregistreringsdatum
Först inskickad
30 april 2026
Först inskickad som uppfyllde QC-kriterierna
30 april 2026
Första postat (Faktisk)
6 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Sjukdomar i nervsystemet
- Näringsstörningar
- Övernäring
- Kroppsvikt
- Luftvägssjukdomar
- Andningsstörningar
- Vakna sömnstörningar
- Apné
- Sömnstörningar, inneboende
- Dyssomni
- Sömnapnésyndrom
- Patologiska tillstånd, tecken och symtom
- Närings- och metabola sjukdomar
- Tecken och symtom
- Övervikt
- Fetma
- Sömnapné, obstruktiv
Andra studie-ID-nummer
- NN9490-8293
- U1111-1313-6538 (Annan identifierare: World Health Organization (WHO))
- 2024-520443-16 (Annan identifierare: European Medical Agency (EMA))
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .