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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)

10. september 2026 oppdatert 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 Not Treated With Positive Airway Pressure (AMAZE 3)

This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with excess body weight and obstructive sleep apnoea not treated with positive airway pressure lose weight and improve sleep apnoea. 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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

300

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Clinical Transparency dept. 2834, Novo Nordisk A/S

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. mai 2026

Primær fullføring (Antatt)

12. juli 2028

Studiet fullført (Antatt)

4. oktober 2028

Datoer for studieregistrering

Først innsendt

30. april 2026

Først innsendt som oppfylte QC-kriteriene

30. april 2026

Først lagt ut (Faktiske)

6. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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. .

Abonnere