- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Novo Nordisk
- Telefonnummer: (+1) 866-867-7178
- E-post: clinicaltrials@novonordisk.com
Studiesteder
-
-
New South Wales
-
Macquarie Park, New South Wales, Australia, 2113
- Rekruttering
- Woolcock Institute
-
-
Queensland
-
Birtinya, Queensland, Australia, 4575
- Rekruttering
- University of Sunshine Coast - Vitality Village
-
South Brisbane, Queensland, Australia, 4101
- Har ikke rekruttert ennå
- Mater Research - RIO Clinical Trials Unit
-
-
South Australia
-
Adelaide, South Australia, Australia, 5000
- Rekruttering
- Nightingale Research Adelaide
-
-
Western Australia
-
Crawley, Western Australia, Australia, 6009
- Rekruttering
- University of Western Australia - Centre for Sleep Science
-
-
-
-
-
Herning, Danmark, 7400
- Rekruttering
- Regionshospitalet Gødstrup, Øre-næse-hals-kirurgisk
-
Køge, Danmark, 4600
- Rekruttering
- Sjællands Universitetshospital, Køge - Øre-Næse-Hals afdeling
-
-
-
-
California
-
San Diego, California, Forente stater, 92123
- Rekruttering
- Artemis Insitute for Clin Res
-
-
Florida
-
Miami, Florida, Forente stater, 33176
- Rekruttering
- PharmaDev Clinical Research Institute LLC
-
Naples, Florida, Forente stater, 34102
- Har ikke rekruttert ennå
- Essence MD Research
-
Ocala, Florida, Forente stater, 34470
- Rekruttering
- Renstar Medical Research
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30328
- Rekruttering
- Conquest Research
-
Lawrenceville, Georgia, Forente stater, 30046
- Rekruttering
- Physicians Research Associates
-
-
Illinois
-
Chicago, Illinois, Forente stater, 60637
- Rekruttering
- University of Chicago
-
-
New York
-
New York, New York, Forente stater, 10021
- Rekruttering
- Weil Cornell Medicine
-
-
Ohio
-
Cincinnati, Ohio, Forente stater, 45212
- Rekruttering
- CTI Clinical Research Center
-
-
Pennsylvania
-
DuBois, Pennsylvania, Forente stater, 15801
- Har ikke rekruttert ennå
- Clinical Research Associates of Central PA, LLC
-
-
Texas
-
DeSoto, Texas, Forente stater, 75115
- Rekruttering
- Epic Medical Research
-
El Paso, Texas, Forente stater, 79912
- Rekruttering
- Advanced Neurology Epilepsy and Sleep Center ANESC
-
El Paso, Texas, Forente stater, 79912
- Rekruttering
- Biorhythms Center for Integrative Sleep Medicine
-
Houston, Texas, Forente stater, 77089
- Rekruttering
- Houston Pulm Med Res Network
-
San Antonio, Texas, Forente stater, 78229
- Rekruttering
- Sleep Therapy Research Center
-
Sugar Land, Texas, Forente stater, 77478
- Rekruttering
- Tricoastal Sleep Center
-
-
Washington
-
Renton, Washington, Forente stater, 98057
- Rekruttering
- Rainier Clin Res Ctr Inc
-
-
-
-
-
Jaipur, India, 302039
- Rekruttering
- Asthma Bhawan
-
New Delhi, India, 110029
- Rekruttering
- Vardhaman Mahavir Medical College & Safdarjung Hospital
-
-
Andhra Pradesh
-
Guntur, Andhra Pradesh, India, 522004,
- Fullført
- Guntur Government medical College
-
Vijayawada, Andhra Pradesh, India, 520008
- Rekruttering
- Government Siddhartha Medical College & Government General Hospital, Vijayawada
-
-
Karnataka
-
Bengaluru, Karnataka, India, 560074
- Rekruttering
- Rajarajeswari Medical College and Hospital
-
-
Kerala
-
Kochi, Kerala, India, 682041
- Rekruttering
- Amrita Institute of Medical Sciences & Research Centre
-
-
Maharashtra
-
Mumbai, Maharashtra, India, 401107
- Rekruttering
- Bhaktivedanta Hospital & Research Institute
-
Nagpur, Maharashtra, India, 440010
- Rekruttering
- Asian Kidney Hospital And Medical Centre
-
-
New Delhi
-
Delhi, New Delhi, India, 110029
- Har ikke rekruttert ennå
- All India Institute of Medical Sciences_Delhi
-
-
Odisha
-
Bhubaneswar, Odisha, India, 751019
- Har ikke rekruttert ennå
- All India Institute of Medical Sciences (AIIMS), Bhubaneswar
-
-
Telangana
-
Hyderabad, Telangana, India, 500084
- Fullført
- Yashoda Hospital
-
-
Uttar Pradesh
-
Lucknow, Uttar Pradesh, India, 226006
- Rekruttering
- Midland Healthcare & Research Center
-
-
West Bengal
-
Kolkata, West Bengal, India, 700054
- Rekruttering
- Apollo Multispeciality Hospital, Kolkata
-
-
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100044
- Rekruttering
- Peking University People's Hospital-Endocrinology
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210011
- Rekruttering
- The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
-
Suzhou, Jiangsu, Kina, 215006
- Rekruttering
- The First Affiliated Hospital of Soochow University-Endocrinology
-
Zhenjiang, Jiangsu, Kina, 212001
- Rekruttering
- The Affiliated Hospital of Jiangsu University-Endocrinology
-
-
Zhejiang
-
Huzhou, Zhejiang, Kina, 313000
- Rekruttering
- Huzhou Central Hospital-Endocrinology
-
-
-
-
-
Gdansk, Polen, 80-214
- Rekruttering
- Uniwersyteckie Centrum Kliniczne
-
Gdansk, Polen, 80-546
- Rekruttering
- Penta Hospitals Badania Kliniczne Sp. z o.o.
-
Krakow, Polen, 31-202
- Fullført
- Krakowski Szpital Specjalistyczny im. Jana Pawla II
-
Krakow, Polen, 30-901
- Rekruttering
- 5 Wojskowy Szpital Kliniczny z Polikliniką-Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie
-
Poznan, Polen, 60-569
- Rekruttering
- Uniwersytecki Szpital Kliniczny W Poznaniu
-
Warsaw, Polen, 02-507
- Rekruttering
- Państwowy Instytut Medyczny MSWiA
-
Warsaw, Polen, 02-677
- Rekruttering
- ETG Warszawa Sp. z o.o.
-
Warsaw, Polen, 01-138
- Rekruttering
- National Institute Of Tuberculosis And Lung Diseases - Instytut Gruźlicy i Chorób Płuc
-
Warsaw, Polen, 00-124
- Rekruttering
- Gyncentrum Sp. z o. o.
-
-
Dolnoslaskie Voivodeship
-
Wroclaw, Dolnoslaskie Voivodeship, Polen, 50-981
- Rekruttering
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
-
-
-
-
-
Barcelona, Spania, 08035
- Rekruttering
- Hospital Vall d'hebrón
-
Castilleja de la Cuesta, Spania, 41950
- Rekruttering
- Hospital Vithas Sevilla
-
Lleida, Spania, 25198
- Rekruttering
- Hospital Univ. de Santa María de Lleida
-
Logroño, Spania, 26006
- Rekruttering
- Hospital Universitario San Pedro
-
Madrid, Spania, 28034
- Rekruttering
- Hospital Ramon y Cajal
-
Madrid, Spania, 28036
- Rekruttering
- Instituto de Investigaciones del Sueño
-
Vitoria-Gasteiz, Spania, 01004
- Rekruttering
- Hospital Universitario de Araba
-
-
Castille-La Mancha
-
Guadalajara, Castille-La Mancha, Spania, 19002
- Rekruttering
- Hospital Universitario de Guadalajara
-
-
Madrid
-
Pozuelo de Alarcón, Madrid, Spania, 28223
- Rekruttering
- H.U. Quirónsalud Madrid
-
-
-
-
-
Chiayi City, Taiwan, 600
- Har ikke rekruttert ennå
- Ditmanson Medical Foundation Chia-Yi Christian Hospital
-
Taipei, Taiwan, 110
- Rekruttering
- Taipei Medical University Hospital
-
Taipei, Taiwan, 106
- Rekruttering
- Cathay General Hospital
-
Taipei, Taiwan, 116
- Rekruttering
- Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology
-
Taoyuan, Taiwan, 333
- Rekruttering
- Chang Gung Memorial Hospital, Linkou
-
-
-
-
-
Alanya/ Antalya, Tyrkia (Türkiye), 07400
- Rekruttering
- T.C. Sağlık Bakanlığı Alaaddin Keykubat Üniversitesi Alanya Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
-
Maltepe/İstanbull, Tyrkia (Türkiye), 34843
- Rekruttering
- İstanbul İl Sağlik Müdürlüğü Süreyyapaşa Göğüs Hastaliklari Ve Göğüs Cerrahisi Eğitim Ve Araştirma Hastanesi
-
Merkez/Battalgazi/Malatya, Tyrkia (Türkiye), 44280
- Rekruttering
- İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları
-
Merkez/Çorum, Tyrkia (Türkiye), 19040
- Rekruttering
- Hitit Üniversitesi Çorum Erol Olçok Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
-
Yenimahalle / Ankara, Tyrkia (Türkiye), 06170
- Rekruttering
- Ankara Etlik Şehir Hastanesi-Göğüs Hastalıkları
-
Yuregir/Adana, Tyrkia (Türkiye), 01060
- Rekruttering
- Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye
-
Yıldırım/Bursa, Tyrkia (Türkiye), 16310
- Rekruttering
- Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
-
Zeytinburnu/İstanbul, Tyrkia (Türkiye), 34020
- Rekruttering
- Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi
-
-
-
-
-
Bochum, Tyskland, 44787
- Rekruttering
- Siteworks GmbH Bochum
-
Hamburg, Tyskland, 22607
- Rekruttering
- Wendisch - Dahl Hamburg - DZHW
-
Hanover, Tyskland, 30449
- Rekruttering
- Siteworks GmbH Hannover
-
Karlsruhe, Tyskland, 76137
- Rekruttering
- Siteworks GmbH Karlsruhe
-
Münster, Tyskland, 48145
- Rekruttering
- Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
-
Schleswig, Tyskland, 24837
- Rekruttering
- Siteworks GmbH - Prüfzentrum Schleswig | RespiRatio
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo
Deltakerne vil motta placebo som tilsvarer NNC0487-0111 subkutant en gang i uken som et tillegg til en kaloriredusert diett og økt fysisk aktivitet.
|
Placebo matchet til NNC0487-0111 vil bli administrert subkutant ved bruk av PDS290 fylte penn-injektorer til en av kroppsdelene: lår, mage eller overarm.
|
|
Eksperimentell: NNC0487-0111
Deltakerne vil bli randomisert til å motta 1 av 2 dosenivåer av NNC0487-0111 subkutant én gang i uken som et tillegg til en kaloriredusert diett og økt fysisk aktivitet.
|
NNC0487-0111 vil bli administrert subkutant ved bruk av PDS290 fylte penn-injektorer til en av kroppsdelene: lår, mage eller overarm.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Relative change in body weight
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as percentage (%) change in body weight.
|
From baseline (week 0) to (week 80)
|
|
Change in apnoea-hypopnoea index (AHI)
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as events/hour.
|
From baseline (week 0) to (week 80)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Endring i midjemål
Tidsramme: Fra utgangspunkt (uke 0) til (uke 80)
|
Målt i centimeter (cm).
|
Fra utgangspunkt (uke 0) til (uke 80)
|
|
Endring i systolisk blodtrykk (SBP)
Tidsramme: Fra baseline (uke 0) til (uke 80)
|
Målt i millimeter kvikksølv (mmHg).
|
Fra baseline (uke 0) til (uke 80)
|
|
Endring i diastolisk blodtrykk (DBP)
Tidsramme: Fra utgangspunktet (uke 0) til (uke 80)
|
Målt i mmHg.
|
Fra utgangspunktet (uke 0) til (uke 80)
|
|
Antall TEAE-er som fører til permanent behandlingsavbrudd
Tidsramme: Fra utgangspunkt (uke 0) til uke 84
|
Målt som hendelser.
|
Fra utgangspunkt (uke 0) til uke 84
|
|
Relative change in AHI
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as percentage change in AHI.
|
From baseline (week 0) to (week 80)
|
|
Achievement of 50% reduction in AHI (Yes/No)
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as number of participant.
|
From baseline (week 0) to (week 80)
|
|
Achievement of: AHI less than (<) 5
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as number of participants.
|
From baseline (week 0) to (week 80)
|
|
Change in ESS score
Tidsramme: 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)
|
|
Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score
Tidsramme: 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
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as kilogram (Kg).
|
From baseline (week 0) to (week 80)
|
|
Change in body mass index (BMI)
Tidsramme: 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)
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as number of participants.
|
From baseline (week 0) to (week 80)
|
|
Change in neck circumference
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as cm.
|
From baseline (week 0) to (week 80)
|
|
Change in Total cholesterol
Tidsramme: 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
Tidsramme: 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
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline.
|
From baseline (week 0) to (week 80)
|
|
Change in Non-HDL cholesterol
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline.
|
From baseline (week 0) to (week 80)
|
|
Change in Triglycerides
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline.
|
From baseline (week 0) to (week 80)
|
|
Change in fasting plasma glucose
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline.
|
From baseline (week 0) to (week 80)
|
|
Change in glycated haemoglobin (HbA1c)
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as % of HbA1c.
|
From baseline (week 0) to (week 80)
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Clinical Transparency dept. 2834, Novo Nordisk A/S
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i nervesystemet
- Ernæringsforstyrrelser
- Overernæring
- Kroppsvekt
- Sykdommer i luftveiene
- Respirasjonsforstyrrelser
- Søvnvåkenforstyrrelser
- Apné
- Søvnforstyrrelser, iboende
- Dyssomnier
- Søvnapné syndromer
- Patologiske tilstander, tegn og symptomer
- Ernæringsmessige og metabolske sykdommer
- Tegn og symptomer
- Overvektig
- Overvekt
- Søvnapné, obstruktiv
Andre studie-ID-numre
- NN9490-8025
- U1111-1313-6359 (Annen identifikator: World Health Organization (WHO))
- 2024-520442-36 (Annen identifikator: European Medical Agency (EMA))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .