- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07571005
AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea (AMAZE 3)
Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure (AMAZE 3)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 3
Contacten en locaties
Studiecontact
- Naam: Novo Nordisk
- Telefoonnummer: (+1) 866-867-7178
- E-mail: clinicaltrials@novonordisk.com
Studie Locaties
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New South Wales
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Macquarie Park, New South Wales, Australië, 2113
- Werving
- Woolcock Institute
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Queensland
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Birtinya, Queensland, Australië, 4575
- Werving
- University of Sunshine Coast - Vitality Village
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South Brisbane, Queensland, Australië, 4101
- Nog niet aan het werven
- Mater Research - RIO Clinical Trials Unit
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South Australia
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Adelaide, South Australia, Australië, 5000
- Werving
- Nightingale Research Adelaide
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Western Australia
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Crawley, Western Australia, Australië, 6009
- Werving
- University of Western Australia - Centre for Sleep Science
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100044
- Werving
- Peking University People's Hospital-Endocrinology
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Jiangsu
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Nanjing, Jiangsu, China, 210011
- Werving
- The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
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Suzhou, Jiangsu, China, 215006
- Werving
- The First Affiliated Hospital of Soochow University-Endocrinology
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Zhenjiang, Jiangsu, China, 212001
- Werving
- The Affiliated Hospital of Jiangsu University-Endocrinology
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Zhejiang
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Huzhou, Zhejiang, China, 313000
- Werving
- Huzhou Central Hospital-Endocrinology
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Herning, Denemarken, 7400
- Werving
- Regionshospitalet Gødstrup, Øre-næse-hals-kirurgisk
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Køge, Denemarken, 4600
- Werving
- Sjællands Universitetshospital, Køge - Øre-Næse-Hals afdeling
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Bochum, Duitsland, 44787
- Werving
- Siteworks GmbH Bochum
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Hamburg, Duitsland, 22607
- Werving
- Wendisch - Dahl Hamburg - DZHW
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Hanover, Duitsland, 30449
- Werving
- Siteworks GmbH Hannover
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Karlsruhe, Duitsland, 76137
- Werving
- Siteworks GmbH Karlsruhe
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Münster, Duitsland, 48145
- Werving
- Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
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Schleswig, Duitsland, 24837
- Werving
- Siteworks GmbH - Prüfzentrum Schleswig | RespiRatio
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Jaipur, Indië, 302039
- Werving
- Asthma Bhawan
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New Delhi, Indië, 110029
- Werving
- Vardhaman Mahavir Medical College & Safdarjung Hospital
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Andhra Pradesh
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Guntur, Andhra Pradesh, Indië, 522004,
- Voltooid
- Guntur Government medical College
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Vijayawada, Andhra Pradesh, Indië, 520008
- Werving
- Government Siddhartha Medical College & Government General Hospital, Vijayawada
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Karnataka
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Bengaluru, Karnataka, Indië, 560074
- Werving
- Rajarajeswari Medical College and Hospital
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Kerala
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Kochi, Kerala, Indië, 682041
- Werving
- Amrita Institute of Medical Sciences & Research Centre
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Maharashtra
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Mumbai, Maharashtra, Indië, 401107
- Werving
- Bhaktivedanta Hospital & Research Institute
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Nagpur, Maharashtra, Indië, 440010
- Werving
- Asian Kidney Hospital And Medical Centre
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New Delhi
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Delhi, New Delhi, Indië, 110029
- Nog niet aan het werven
- All India Institute of Medical Sciences_Delhi
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Odisha
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Bhubaneswar, Odisha, Indië, 751019
- Nog niet aan het werven
- All India Institute of Medical Sciences (AIIMS), Bhubaneswar
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Telangana
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Hyderabad, Telangana, Indië, 500084
- Voltooid
- Yashoda Hospital
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Uttar Pradesh
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Lucknow, Uttar Pradesh, Indië, 226006
- Werving
- Midland Healthcare & Research Center
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West Bengal
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Kolkata, West Bengal, Indië, 700054
- Werving
- Apollo Multispeciality Hospital, Kolkata
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Gdansk, Polen, 80-214
- Werving
- Uniwersyteckie Centrum Kliniczne
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Gdansk, Polen, 80-546
- Werving
- Penta Hospitals Badania Kliniczne Sp. z o.o.
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Krakow, Polen, 31-202
- Voltooid
- Krakowski Szpital Specjalistyczny im. Jana Pawla II
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Krakow, Polen, 30-901
- Werving
- 5 Wojskowy Szpital Kliniczny z Polikliniką-Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie
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Poznan, Polen, 60-569
- Werving
- Uniwersytecki Szpital Kliniczny W Poznaniu
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Warsaw, Polen, 02-507
- Werving
- Państwowy Instytut Medyczny MSWiA
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Warsaw, Polen, 02-677
- Werving
- ETG Warszawa Sp. z o.o.
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Warsaw, Polen, 01-138
- Werving
- National Institute Of Tuberculosis And Lung Diseases - Instytut Gruźlicy i Chorób Płuc
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Warsaw, Polen, 00-124
- Werving
- Gyncentrum Sp. z o. o.
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Dolnoslaskie Voivodeship
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Wroclaw, Dolnoslaskie Voivodeship, Polen, 50-981
- Werving
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
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Barcelona, Spanje, 08035
- Werving
- Hospital Vall d'hebrón
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Castilleja de la Cuesta, Spanje, 41950
- Werving
- Hospital Vithas Sevilla
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Lleida, Spanje, 25198
- Werving
- Hospital Univ. de Santa María de Lleida
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Logroño, Spanje, 26006
- Werving
- Hospital Universitario San Pedro
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Madrid, Spanje, 28034
- Werving
- Hospital Ramon y Cajal
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Madrid, Spanje, 28036
- Werving
- Instituto de Investigaciones del Sueño
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Vitoria-Gasteiz, Spanje, 01004
- Werving
- Hospital Universitario de Araba
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Castille-La Mancha
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Guadalajara, Castille-La Mancha, Spanje, 19002
- Werving
- Hospital Universitario de Guadalajara
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Madrid
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Pozuelo de Alarcón, Madrid, Spanje, 28223
- Werving
- H.U. Quirónsalud Madrid
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Chiayi City, Taiwan, 600
- Nog niet aan het werven
- Ditmanson Medical Foundation Chia-Yi Christian Hospital
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Taipei, Taiwan, 110
- Werving
- Taipei Medical University Hospital
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Taipei, Taiwan, 106
- Werving
- Cathay General Hospital
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Taipei, Taiwan, 116
- Werving
- Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology
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Taoyuan, Taiwan, 333
- Werving
- Chang Gung Memorial Hospital, Linkou
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Alanya/ Antalya, Turkije (Türkiye), 07400
- Werving
- T.C. Sağlık Bakanlığı Alaaddin Keykubat Üniversitesi Alanya Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
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Maltepe/İstanbull, Turkije (Türkiye), 34843
- Werving
- İstanbul İl Sağlik Müdürlüğü Süreyyapaşa Göğüs Hastaliklari Ve Göğüs Cerrahisi Eğitim Ve Araştirma Hastanesi
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Merkez/Battalgazi/Malatya, Turkije (Türkiye), 44280
- Werving
- İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları
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Merkez/Çorum, Turkije (Türkiye), 19040
- Werving
- Hitit Üniversitesi Çorum Erol Olçok Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
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Yenimahalle / Ankara, Turkije (Türkiye), 06170
- Werving
- Ankara Etlik Şehir Hastanesi-Göğüs Hastalıkları
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Yuregir/Adana, Turkije (Türkiye), 01060
- Werving
- Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye
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Yıldırım/Bursa, Turkije (Türkiye), 16310
- Werving
- Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
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Zeytinburnu/İstanbul, Turkije (Türkiye), 34020
- Werving
- Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi
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California
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San Diego, California, Verenigde Staten, 92123
- Werving
- Artemis Insitute for Clin Res
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Florida
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Miami, Florida, Verenigde Staten, 33176
- Werving
- PharmaDev Clinical Research Institute LLC
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Naples, Florida, Verenigde Staten, 34102
- Nog niet aan het werven
- Essence MD Research
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Ocala, Florida, Verenigde Staten, 34470
- Werving
- Renstar Medical Research
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30328
- Werving
- Conquest Research
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Lawrenceville, Georgia, Verenigde Staten, 30046
- Werving
- Physicians Research Associates
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Illinois
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Chicago, Illinois, Verenigde Staten, 60637
- Werving
- University of Chicago
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New York
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New York, New York, Verenigde Staten, 10021
- Werving
- Weil Cornell Medicine
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45212
- Werving
- CTI Clinical Research Center
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Pennsylvania
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DuBois, Pennsylvania, Verenigde Staten, 15801
- Nog niet aan het werven
- Clinical Research Associates of Central PA, LLC
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Texas
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DeSoto, Texas, Verenigde Staten, 75115
- Werving
- Epic Medical Research
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El Paso, Texas, Verenigde Staten, 79912
- Werving
- Advanced Neurology Epilepsy and Sleep Center ANESC
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El Paso, Texas, Verenigde Staten, 79912
- Werving
- Biorhythms Center for Integrative Sleep Medicine
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Houston, Texas, Verenigde Staten, 77089
- Werving
- Houston Pulm Med Res Network
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San Antonio, Texas, Verenigde Staten, 78229
- Werving
- Sleep Therapy Research Center
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Sugar Land, Texas, Verenigde Staten, 77478
- Werving
- Tricoastal Sleep Center
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Washington
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Renton, Washington, Verenigde Staten, 98057
- Werving
- Rainier Clin Res Ctr Inc
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Placebo-vergelijker: Placebo
Deelnemers zullen een placebo krijgen dat overeenkomt met NNC0487-0111, eenmaal per week subcutaan toegediend, als aanvulling op een caloriebeperkt dieet en meer lichaamsbeweging.
|
Placebo, afgestemd op NNC0487-0111, wordt subcutaan toegediend met behulp van PDS290 voorgevulde pen-injectoren op een van de lichaamsdelen: dij, buik of bovenarm.
|
|
Experimenteel: NNC0487-0111
Deelnemers worden gerandomiseerd om 1 van de 2 doseringsniveaus van NNC0487-0111 subcutaan eenmaal per week te ontvangen als aanvulling op een caloriebeperkt dieet en verhoogde fysieke activiteit.
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NNC0487-0111 wordt subcutaan toegediend met PDS290 voorgevulde peninjectoren op één van de lichaamsdelen: dij, buik of bovenarm.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Relative change in body weight
Tijdsspanne: From baseline (week 0) to (week 80)
|
Measured as percentage (%) change in body weight.
|
From baseline (week 0) to (week 80)
|
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Change in apnoea-hypopnoea index (AHI)
Tijdsspanne: From baseline (week 0) to (week 80)
|
Measured as events/hour.
|
From baseline (week 0) to (week 80)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Verandering in middelomtrek
Tijdsspanne: Van baseline (week 0) tot (week 80)
|
Gemeten in centimeter (cm).
|
Van baseline (week 0) tot (week 80)
|
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Verandering in systolische bloeddruk (SBP)
Tijdsspanne: Van baseline (week 0) tot (week 80)
|
Gemeten als millimeter kwik (mmHg).
|
Van baseline (week 0) tot (week 80)
|
|
Verandering in diastolische bloeddruk (DBP)
Tijdsspanne: Vanaf baseline (week 0) tot (week 80)
|
Gemeten in mmHg.
|
Vanaf baseline (week 0) tot (week 80)
|
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Aantal TEAEs die leiden tot permanente behandelingstaken
Tijdsspanne: Vanaf de baseline (week 0) tot week 84
|
Gemeten als gebeurtenissen.
|
Vanaf de baseline (week 0) tot week 84
|
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Relative change in AHI
Tijdsspanne: From baseline (week 0) to (week 80)
|
Measured as percentage change in AHI.
|
From baseline (week 0) to (week 80)
|
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Achievement of 50% reduction in AHI (Yes/No)
Tijdsspanne: 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
Tijdsspanne: 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 ESS score
Tijdsspanne: 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 PROMIS Short Form v1.0 Sleep Disturbance 8b score
Tijdsspanne: 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
Tijdsspanne: From baseline (week 0) to (week 80)
|
Measured as kilogram (Kg).
|
From baseline (week 0) to (week 80)
|
|
Change in body mass index (BMI)
Tijdsspanne: From baseline (week 0) to (week 80)
|
Measured as kilograms per meter square (kg/m^2).
|
From baseline (week 0) to (week 80)
|
|
Improvement in obstructive sleep apnoea (OSA) severity category: AHI < 5/hour = normal (Yes/No)
Tijdsspanne: From baseline (week 0) to (week 80)
|
Measured as number of participants.
|
From baseline (week 0) to (week 80)
|
|
Change in neck circumference
Tijdsspanne: From baseline (week 0) to (week 80)
|
Measured as cm.
|
From baseline (week 0) to (week 80)
|
|
Change in Total cholesterol
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline.
|
From baseline (week 0) to (week 80)
|
|
Change in Non-HDL cholesterol
Tijdsspanne: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline.
|
From baseline (week 0) to (week 80)
|
|
Change in Triglycerides
Tijdsspanne: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline.
|
From baseline (week 0) to (week 80)
|
|
Change in fasting plasma glucose
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: From baseline (week 0) to week 84
|
Measured as Events.
|
From baseline (week 0) to week 84
|
|
Achievement of: AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No)
Tijdsspanne: From baseline (week 0) to (week 80)
|
Measures as number of participants
|
From baseline (week 0) to (week 80)
|
|
Change in sleep apnoea specific hypoxic burden (SASHB)
Tijdsspanne: From baseline (week 0) to (week 80)
|
Measured as percentage minutes per hour (%min/h).
|
From baseline (week 0) to (week 80)
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score
Tijdsspanne: 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 wakefulness 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)
|
|
Improvement in obstructive sleep apnoea (OSA) severity category: ≥ 5 and < 15/hour = mild (Yes/No)
Tijdsspanne: From baseline (week 0) to (week 80)
|
Measured as number of participants.
|
From baseline (week 0) to (week 80)
|
|
Improvement in obstructive sleep apnoea (OSA) severity category: ≥ 15 and < 30/hour = moderate (Yes/No)
Tijdsspanne: From baseline (week 0) to (week 80)
|
Measured as number of participants.
|
From baseline (week 0) to (week 80)
|
|
Improvement in obstructive sleep apnoea (OSA) severity category: ≥ 30/hour = severe (Yes/No)
Tijdsspanne: From baseline (week 0) to (week 80)
|
Measured as number of participants.
|
From baseline (week 0) to (week 80)
|
|
Change in high-sensitivity C-reactive protein (hsCRP)
Tijdsspanne: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline
|
From baseline (week 0) to (week 80)
|
|
Chage in Very low-density lipoprotein (VLDL) cholesterol
Tijdsspanne: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline.
|
From baseline (week 0) to (week 80)
|
|
Change in glycated haemoglobin (HbA1c)
Tijdsspanne: From baseline (week 0) to (week 80)
|
Measured as % of HbA1c.
|
From baseline (week 0) to (week 80)
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Clinical Transparency dept. 2834, Novo Nordisk A/S
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het zenuwstelsel
- Voedingsstoornissen
- Overvoeding
- Lichaamsgewicht
- Ziekten van de luchtwegen
- Ademhalingsstoornissen
- Slaap-waakstoornissen
- Apneu
- Slaapstoornissen, intrinsiek
- Dyssomnieën
- Slaapapneusyndromen
- Pathologische aandoeningen, tekenen en symptomen
- Voedings- en stofwisselingsziekten
- Tekenen en symptomen
- Overgewicht
- Obesitas
- Slaapapneu, obstructief
Andere studie-ID-nummers
- NN9490-8025
- U1111-1313-6359 (Andere identificatie: World Health Organization (WHO))
- 2024-520442-36 (Andere identificatie: European Medical Agency (EMA))
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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