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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)

19. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

300

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Australien
    • New South Wales
      • Macquarie Park, New South Wales, Australien, 2113
        • Rekruttering
        • Woolcock Institute
    • Queensland
      • Birtinya, Queensland, Australien, 4575
        • Rekruttering
        • University of Sunshine Coast - Vitality Village
      • South Brisbane, Queensland, Australien, 4101
        • Ikke rekrutterer endnu
        • Mater Research - RIO Clinical Trials Unit
    • South Australia
      • Adelaide, South Australia, Australien, 5000
        • Rekruttering
        • Nightingale Research
    • Western Australia
      • Crawley, Western Australia, Australien, 6009
        • Rekruttering
        • University of Western Australia - Centre for Sleep Science
  • Forenede Stater
    • Arizona
      • Gilbert, Arizona, Forenede Stater, 85297
        • Rekruttering
        • Dignity Health, Mercy Gilbert
    • Florida
      • Bradenton, Florida, Forenede Stater, 34209
        • Rekruttering
        • DM Clinical
      • Naples, Florida, Forenede Stater, 34102
        • Rekruttering
        • Essence MD Research
      • West Palm Beach, Florida, Forenede Stater, 33409
        • Rekruttering
        • Palm Beach Research Center
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30328
        • Rekruttering
        • NeuroTrials Research, Inc.
      • Lawrenceville, Georgia, Forenede Stater, 30046
        • Rekruttering
        • Physicians Research Associates
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60634
        • Rekruttering
        • Chicago Research Center, Inc
    • New York
      • New York, New York, Forenede Stater, 10021
        • Ikke rekrutterer endnu
        • Weil Cornell Medicine
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58104
        • Rekruttering
        • Lillestol Research LLC
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45212
        • Rekruttering
        • CTI Clinical Research Center
    • Pennsylvania
      • DuBois, Pennsylvania, Forenede Stater, 15801
        • Ikke rekrutterer endnu
        • Clinical Research Associates of Central PA, LLC
    • South Carolina
      • Columbia, South Carolina, Forenede Stater, 29201
        • Rekruttering
        • Bogan Sleep Consultants, LLC
    • Texas
      • DeSoto, Texas, Forenede Stater, 75115
        • Rekruttering
        • Epic Medical Research
      • El Paso, Texas, Forenede Stater, 79912
        • Rekruttering
        • Advanced Neurology Epilepsy and Sleep Center ANESC
      • El Paso, Texas, Forenede Stater, 79912
        • Rekruttering
        • Biorhythms Center for Integrative Sleep Medicine
      • Houston, Texas, Forenede Stater, 77089
        • Rekruttering
        • Houston Pulmonary Medicine Associates, PA
      • San Antonio, Texas, Forenede Stater, 78229
        • Rekruttering
        • Sleep Therapy Research Center
      • Sugar Land, Texas, Forenede Stater, 77478
        • Rekruttering
        • Tricoastal Sleep Center
    • Washington
      • Renton, Washington, Forenede Stater, 98057
        • Rekruttering
        • Rainier Clin Res Ctr Inc
      • Seattle, Washington, Forenede Stater, 98104
        • Rekruttering
        • Seattle Clinical Research Center
  • Indien
      • Jaipur, Indien, 302039
        • Ikke rekrutterer endnu
        • Asthma Bhawan
    • Andhra Pradesh
      • Guntur, Andhra Pradesh, Indien, 522004,
        • Trukket tilbage
        • Guntur Government medical College
      • Vijayawada, Andhra Pradesh, Indien, 520008
        • Ikke rekrutterer endnu
        • Government Siddhartha Medical College & Government General Hospital, Vijayawada
    • Karnataka
      • Bengaluru, Karnataka, Indien, 560074
        • Ikke rekrutterer endnu
        • RajaRajeswari Medical College and Hospital
    • Kerala
      • Kochi, Kerala, Indien, 682041
        • Ikke rekrutterer endnu
        • Amrita Institute Of Medical Sciences & Research Centre
    • Maharashtra
      • Mumbai, Maharashtra, Indien, 401107
        • Ikke rekrutterer endnu
        • Bhaktivedanta Hospital & Research Institute
      • Nagpur, Maharashtra, Indien, 440010
        • Ikke rekrutterer endnu
        • Asian Kidney Hospital And Medical Centre
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, Indien, 110029
        • Ikke rekrutterer endnu
        • Vardhaman Mahavir Medical College & Safdarjung Hospital
    • New Delhi
      • Delhi, New Delhi, Indien, 110029
        • Ikke rekrutterer endnu
        • All India Institute of Medical Sciences_Delhi
    • Odisha
      • Bhubaneswar, Odisha, Indien, 751019
        • Ikke rekrutterer endnu
        • All India Institute of Medical Sciences (AIIMS), Bhubaneswar
    • Telangana
      • Hyderabad, Telangana, Indien, 500084
        • Trukket tilbage
        • Yashoda Hospital
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, Indien, 226006
        • Ikke rekrutterer endnu
        • Midland Healthcare & Research Center
    • West Bengal
      • Kolkata, West Bengal, Indien, 700054
        • Ikke rekrutterer endnu
        • Apollo Multispeciality Hospital, Kolkata
  • Japan
      • Fukuoka, Japan, 814-0180
        • Ikke rekrutterer endnu
        • Fukuoka University Hospital_Respiratory Medicine
      • Hiroshima, Japan, 730-0051
        • Rekruttering
        • Chatani NeuroSleep Clinic_Neurology
      • Kumamoto, Japan, 862-0954
        • Rekruttering
        • Kuwamizu Hospital_Internal Medicine
      • Okinawa, Japan, 901-2132
        • Rekruttering
        • Nakamura Clinic_Pulmonology
      • Osaka, Japan, 532-0003
        • Rekruttering
        • Osaka Kaisei Hospital_Sleep Medical Center
      • Sapporo-shi, Hokkaido, Japan, 062-0931
        • Rekruttering
        • KKR Sappro Medical Center_Respiratory Medicine
      • Shizuoka, Japan, 436-8555
        • Ikke rekrutterer endnu
        • Chutoen General Medical Center_Neurology
      • Tokyo, Japan, 103-0027
        • Ikke rekrutterer endnu
        • Tokyo-Eki Center-building Clinic_Internal Medicine
      • Tokyo, Japan, 113-8431
        • Ikke rekrutterer endnu
        • Juntendo University Hospital_Cardiovascular Biology And Medicine
      • Tokyo, Japan, 193-0811
        • Rekruttering
        • Tokyo Tenshi Hospital_Internal medicine
  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100044
        • Ikke rekrutterer endnu
        • Peking University People's Hospital-Endocrinology
    • Guangdong
      • Shenzhen, Guangdong, Kina, 518020
        • Ikke rekrutterer endnu
        • Shenzhen People's Hospital-Sleep Medicine Department
    • Henan
      • Luoyang, Henan, Kina, 471003
        • Ikke rekrutterer endnu
        • The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210011
        • Ikke rekrutterer endnu
        • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina, 300052
        • Ikke rekrutterer endnu
        • Tianjin Medical University General Hospital-Respiratory
  • Polen
      • Gdansk, Polen, 80-214
        • Ikke rekrutterer endnu
        • Uniwersyteckie Centrum Kliniczne
      • Gdansk, Polen, 80-546
        • Ikke rekrutterer endnu
        • Centrum Badan Klinicznych PI-House sp. z o.o.
      • Krakow, Polen, 30-901
        • Ikke rekrutterer endnu
        • 5 Wojskowy Szpital Kliniczny z Polikliniką-Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie
      • Krakow, Polen, 31-202
        • Trukket tilbage
        • Krakowski Szpital Specjalistyczny im. Jana Pawla II
      • Poznan, Polen, 60-569
        • Ikke rekrutterer endnu
        • Uniwersytecki Szpital Kliniczny w Poznaniu
      • Warsaw, Polen, 02-507
        • Ikke rekrutterer endnu
        • PANSTWOWY INSTYTUT MEDYCZNY MSWiA
      • Warsaw, Polen, 00-124
        • Ikke rekrutterer endnu
        • Gyncentrum Sp. z o. o.
      • Warsaw, Polen, 01-138
        • Ikke rekrutterer endnu
        • National Institute Of Tuberculosis And Lung Diseases - Instytut Gruźlicy i Chorób Płuc
      • Warsaw, Polen, 02-677
        • Ikke rekrutterer endnu
        • ETG Warszawa Sp. z o.o.
    • Dolnoslaskie Voivodeship
      • Wroclaw, Dolnoslaskie Voivodeship, Polen, 50-981
        • Ikke rekrutterer endnu
        • 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
  • Spanien
      • Barcelona, Spanien, 08035
        • Ikke rekrutterer endnu
        • Hospital Vall d'Hebron
      • Castilleja de la Cuesta, Spanien, 41950
        • Rekruttering
        • Hospital Vithas Sevilla
      • Lleida, Spanien, 25198
        • Rekruttering
        • Hospital Univ. de Santa María de Lleida
      • Logroño, Spanien, 26006
        • Ikke rekrutterer endnu
        • Hospital Universitario San Pedro
      • Madrid, Spanien, 28034
        • Rekruttering
        • Hospital Ramon y Cajal
      • Madrid, Spanien, 28036
        • Rekruttering
        • Instituto de Investigaciones del Sueno
      • Vitoria-Gasteiz, Spanien, 01004
        • Rekruttering
        • Hospital Universitario de Araba
    • Castille-La Mancha
      • Guadalajara, Castille-La Mancha, Spanien, 19002
        • Rekruttering
        • Hospital Universitario de Guadalajara
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spanien, 28223
        • Rekruttering
        • H.U. Quirónsalud Madrid
  • Taiwan
      • Chiayi City, Taiwan, 600
        • Ikke rekrutterer endnu
        • Ditmanson Medical Foundation Chia-Yi Christian Hospital
      • Taipei, Taiwan, 106
        • Ikke rekrutterer endnu
        • Cathay General Hospital
      • Taipei, Taiwan, 110
        • Ikke rekrutterer endnu
        • Taipei Medical University Hospital
      • Taipei, Taiwan, 116
        • Ikke rekrutterer endnu
        • Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology
      • Taoyuan, Taiwan, 333
        • Ikke rekrutterer endnu
        • Chang Gung Memorial Hospital, Linkou
  • Tyrkiet (Türkiye)
      • Alanya/ Antalya, Tyrkiet (Türkiye), 07400
        • Ikke rekrutterer endnu
        • T.C. Sağlık Bakanlığı Alaaddin Keykubat Üniversitesi Alanya Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
      • Maltepe/İstanbull, Tyrkiet (Türkiye), 34843
        • Rekruttering
        • İstanbul İl Sağlik Müdürlüğü Süreyyapaşa Göğüs Hastaliklari Ve Göğüs Cerrahisi Eğitim Ve Araştirma Hastanesi
      • Merkez/Battalgazi/Malatya, Tyrkiet (Türkiye), 44280
        • Rekruttering
        • İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları
      • Merkez/Çorum, Tyrkiet (Türkiye), 19040
        • Rekruttering
        • Hitit Üniversitesi Çorum Erol Olçok Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
      • Yenimahalle / Ankara, Tyrkiet (Türkiye), 06170
        • Rekruttering
        • Ankara Etlik Şehir Hastanesi-Göğüs Hastalıkları
      • Yuregir/Adana, Tyrkiet (Türkiye), 01060
        • Rekruttering
        • Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye
      • Yıldırım/Bursa, Tyrkiet (Türkiye), 16310
        • Rekruttering
        • Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
      • Zeytinburnu/İstanbul, Tyrkiet (Türkiye), 34020
        • Rekruttering
        • Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi
  • Tyskland
      • 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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Deltagerne vil modtage placebo svarende til NNC0487-0111 subkutant en gang om ugen som supplement til en kaloriereduceret kost og øget fysisk aktivitet.
Medicin: Placebo (matchet til NNC0487-0111)
Placebo svarende til NNC0487-0111 vil blive administreret subkutant ved hjælp af PDS290 fyldte pen-injektorer til en af kropsdelene: lår, mave eller overarm.
Eksperimentel: NNC0487-0111
Deltagerne vil blive randomiseret til at modtage 1 af de 2 doseniveauer af NNC0487-0111 subkutant en gang om ugen som et supplement til en kaloriereduceret diæt og øget fysisk aktivitet.
Medicin: NNC0487-0111
NNC0487-0111 vil blive administreret subkutant ved hjælp af PDS290 præfyldte pen-injektorer til en af følgende kropsdele: lår, mave eller overarm.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
Tidsramme
Ændring i taljemål
Tidsramme: Fra baseline (uge 0) til (uge 80)
Målt i centimeter (cm).
Fra baseline (uge 0) til (uge 80)
Ændring i systolisk blodtryk (SBP)
Tidsramme: Fra baseline (uge 0) til (uge 80)
Målt i millimeter kviksølv (mmHg).
Fra baseline (uge 0) til (uge 80)
Ændring i diastolisk blodtryk (DBP)
Tidsramme: Fra baseline (uge 0) til (uge 80)
Målt i mmHg.
Fra baseline (uge 0) til (uge 80)
Ændring i højfølsomt C-reaktivt protein (hsCRP)
Tidsramme: Fra baseline (uge 0) til (uge 80)
Målt som forhold til udgangspunktet.
Fra baseline (uge 0) til (uge 80)
Ændring i glykeret hæmoglobin (HbA1c)
Tidsramme: Fra baseline (uge 0) til (uge 80)
Målt som procent (%) af HbA1c.
Fra baseline (uge 0) til (uge 80)
Antal TEAE'er, der førte til permanent behandlingsafbrydelse
Tidsramme: Fra baseline (uge 0) til uge 84
Målt som hændelser.
Fra baseline (uge 0) til uge 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)
Achievement of: AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No)
Tidsramme: From baseline (week 0) to (week 80)
Measured 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 %min/h (percentage minutes per hour).
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 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 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)
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)
Improvement in 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 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 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)
Withdrawal of positive airway pressure (PAP) therapy (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 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 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novo Nordisk A/S

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. maj 2026

Primær færdiggørelse (Anslået)

26. juni 2028

Studieafslutning (Anslået)

21. august 2028

Datoer for studieregistrering

Først indsendt

30. april 2026

Først indsendt, der opfyldte QC-kriterier

30. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NN9490-8293
  • U1111-1313-6538 (Anden identifikator: World Health Organization (WHO))
  • 2024-520443-16 (Anden identifikator: European Medical Agency (EMA))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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