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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 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

300

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Allemagne
      • Bochum, Allemagne, 44787
        • Recrutement
        • Siteworks GmbH Bochum
      • Hamburg, Allemagne, 22607
        • Recrutement
        • Wendisch - Dahl Hamburg - DZHW
      • Hanover, Allemagne, 30449
        • Recrutement
        • Siteworks GmbH Hannover
      • Karlsruhe, Allemagne, 76137
        • Recrutement
        • Siteworks GmbH Karlsruhe
      • Münster, Allemagne, 48145
        • Recrutement
        • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
      • Schleswig, Allemagne, 24837
        • Recrutement
        • Siteworks GmbH - Prüfzentrum Schleswig | RespiRatio
  • Australie
    • New South Wales
      • Macquarie Park, New South Wales, Australie, 2113
        • Recrutement
        • Woolcock Institute
    • Queensland
      • Birtinya, Queensland, Australie, 4575
        • Recrutement
        • University of Sunshine Coast - Vitality Village
      • South Brisbane, Queensland, Australie, 4101
        • Pas encore de recrutement
        • Mater Research - RIO Clinical Trials Unit
    • South Australia
      • Adelaide, South Australia, Australie, 5000
        • Recrutement
        • Nightingale Research Adelaide
    • Western Australia
      • Crawley, Western Australia, Australie, 6009
        • Recrutement
        • University of Western Australia - Centre for Sleep Science
  • Chine
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine, 100044
        • Recrutement
        • Peking University People's Hospital-Endocrinology
    • Jiangsu
      • Nanjing, Jiangsu, Chine, 210011
        • Recrutement
        • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
      • Suzhou, Jiangsu, Chine, 215006
        • Recrutement
        • The First Affiliated Hospital of Soochow University-Endocrinology
      • Zhenjiang, Jiangsu, Chine, 212001
        • Recrutement
        • The Affiliated Hospital of Jiangsu University-Endocrinology
    • Zhejiang
      • Huzhou, Zhejiang, Chine, 313000
        • Recrutement
        • Huzhou Central Hospital-Endocrinology
  • Danemark
      • Herning, Danemark, 7400
        • Recrutement
        • Regionshospitalet Gødstrup, Øre-næse-hals-kirurgisk
      • Køge, Danemark, 4600
        • Recrutement
        • Sjællands Universitetshospital, Køge - Øre-Næse-Hals afdeling
  • Espagne
      • Barcelona, Espagne, 08035
        • Recrutement
        • Hospital Vall d'hebrón
      • Castilleja de la Cuesta, Espagne, 41950
        • Recrutement
        • Hospital Vithas Sevilla
      • Lleida, Espagne, 25198
        • Recrutement
        • Hospital Univ. de Santa María de Lleida
      • Logroño, Espagne, 26006
        • Recrutement
        • Hospital Universitario San Pedro
      • Madrid, Espagne, 28034
        • Recrutement
        • Hospital Ramon y Cajal
      • Madrid, Espagne, 28036
        • Recrutement
        • Instituto de Investigaciones del Sueño
      • Vitoria-Gasteiz, Espagne, 01004
        • Recrutement
        • Hospital Universitario de Araba
    • Castille-La Mancha
      • Guadalajara, Castille-La Mancha, Espagne, 19002
        • Recrutement
        • Hospital Universitario de Guadalajara
    • Madrid
      • Pozuelo de Alarcón, Madrid, Espagne, 28223
        • Recrutement
        • H.U. Quirónsalud Madrid
  • Inde
      • Jaipur, Inde, 302039
        • Recrutement
        • Asthma Bhawan
      • New Delhi, Inde, 110029
        • Recrutement
        • Vardhaman Mahavir Medical College & Safdarjung Hospital
    • Andhra Pradesh
      • Guntur, Andhra Pradesh, Inde, 522004,
        • Complété
        • Guntur Government medical College
      • Vijayawada, Andhra Pradesh, Inde, 520008
        • Recrutement
        • Government Siddhartha Medical College & Government General Hospital, Vijayawada
    • Karnataka
      • Bengaluru, Karnataka, Inde, 560074
        • Recrutement
        • Rajarajeswari Medical College and Hospital
    • Kerala
      • Kochi, Kerala, Inde, 682041
        • Recrutement
        • Amrita Institute of Medical Sciences & Research Centre
    • Maharashtra
      • Mumbai, Maharashtra, Inde, 401107
        • Recrutement
        • Bhaktivedanta Hospital & Research Institute
      • Nagpur, Maharashtra, Inde, 440010
        • Recrutement
        • Asian Kidney Hospital And Medical Centre
    • New Delhi
      • Delhi, New Delhi, Inde, 110029
        • Pas encore de recrutement
        • All India Institute of Medical Sciences_Delhi
    • Odisha
      • Bhubaneswar, Odisha, Inde, 751019
        • Pas encore de recrutement
        • All India Institute of Medical Sciences (AIIMS), Bhubaneswar
    • Telangana
      • Hyderabad, Telangana, Inde, 500084
        • Complété
        • Yashoda Hospital
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, Inde, 226006
        • Recrutement
        • Midland Healthcare & Research Center
    • West Bengal
      • Kolkata, West Bengal, Inde, 700054
        • Recrutement
        • Apollo Multispeciality Hospital, Kolkata
  • Pologne
      • Gdansk, Pologne, 80-214
        • Recrutement
        • Uniwersyteckie Centrum Kliniczne
      • Gdansk, Pologne, 80-546
        • Recrutement
        • Penta Hospitals Badania Kliniczne Sp. z o.o.
      • Krakow, Pologne, 31-202
        • Complété
        • Krakowski Szpital Specjalistyczny im. Jana Pawla II
      • Krakow, Pologne, 30-901
        • Recrutement
        • 5 Wojskowy Szpital Kliniczny z Polikliniką-Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie
      • Poznan, Pologne, 60-569
        • Recrutement
        • Uniwersytecki Szpital Kliniczny W Poznaniu
      • Warsaw, Pologne, 02-507
        • Recrutement
        • Państwowy Instytut Medyczny MSWiA
      • Warsaw, Pologne, 02-677
        • Recrutement
        • ETG Warszawa Sp. z o.o.
      • Warsaw, Pologne, 01-138
        • Recrutement
        • National Institute Of Tuberculosis And Lung Diseases - Instytut Gruźlicy i Chorób Płuc
      • Warsaw, Pologne, 00-124
        • Recrutement
        • Gyncentrum Sp. z o. o.
    • Dolnoslaskie Voivodeship
      • Wroclaw, Dolnoslaskie Voivodeship, Pologne, 50-981
        • Recrutement
        • 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
  • Taïwan
      • Chiayi City, Taïwan, 600
        • Pas encore de recrutement
        • Ditmanson Medical Foundation Chia-Yi Christian Hospital
      • Taipei, Taïwan, 110
        • Recrutement
        • Taipei Medical University Hospital
      • Taipei, Taïwan, 106
        • Recrutement
        • Cathay General Hospital
      • Taipei, Taïwan, 116
        • Recrutement
        • Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology
      • Taoyuan, Taïwan, 333
        • Recrutement
        • Chang Gung Memorial Hospital, Linkou
  • Turquie (Türkiye)
      • Alanya/ Antalya, Turquie (Türkiye), 07400
        • Recrutement
        • T.C. Sağlık Bakanlığı Alaaddin Keykubat Üniversitesi Alanya Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
      • Maltepe/İstanbull, Turquie (Türkiye), 34843
        • Recrutement
        • İstanbul İl Sağlik Müdürlüğü Süreyyapaşa Göğüs Hastaliklari Ve Göğüs Cerrahisi Eğitim Ve Araştirma Hastanesi
      • Merkez/Battalgazi/Malatya, Turquie (Türkiye), 44280
        • Recrutement
        • İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları
      • Merkez/Çorum, Turquie (Türkiye), 19040
        • Recrutement
        • Hitit Üniversitesi Çorum Erol Olçok Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
      • Yenimahalle / Ankara, Turquie (Türkiye), 06170
        • Recrutement
        • Ankara Etlik Şehir Hastanesi-Göğüs Hastalıkları
      • Yuregir/Adana, Turquie (Türkiye), 01060
        • Recrutement
        • Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye
      • Yıldırım/Bursa, Turquie (Türkiye), 16310
        • Recrutement
        • Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
      • Zeytinburnu/İstanbul, Turquie (Türkiye), 34020
        • Recrutement
        • Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi
  • États-Unis
    • California
      • San Diego, California, États-Unis, 92123
        • Recrutement
        • Artemis Insitute for Clin Res
    • Florida
      • Miami, Florida, États-Unis, 33176
        • Recrutement
        • PharmaDev Clinical Research Institute LLC
      • Naples, Florida, États-Unis, 34102
        • Pas encore de recrutement
        • Essence MD Research
      • Ocala, Florida, États-Unis, 34470
        • Recrutement
        • Renstar Medical Research
    • Georgia
      • Atlanta, Georgia, États-Unis, 30328
        • Recrutement
        • Conquest Research
      • Lawrenceville, Georgia, États-Unis, 30046
        • Recrutement
        • Physicians Research Associates
    • Illinois
      • Chicago, Illinois, États-Unis, 60637
        • Recrutement
        • University of Chicago
    • New York
      • New York, New York, États-Unis, 10021
        • Recrutement
        • Weil Cornell Medicine
    • Ohio
      • Cincinnati, Ohio, États-Unis, 45212
        • Recrutement
        • CTI Clinical Research Center
    • Pennsylvania
      • DuBois, Pennsylvania, États-Unis, 15801
        • Pas encore de recrutement
        • Clinical Research Associates of Central PA, LLC
    • Texas
      • DeSoto, Texas, États-Unis, 75115
        • Recrutement
        • Epic Medical Research
      • El Paso, Texas, États-Unis, 79912
        • Recrutement
        • Advanced Neurology Epilepsy and Sleep Center ANESC
      • El Paso, Texas, États-Unis, 79912
        • Recrutement
        • Biorhythms Center for Integrative Sleep Medicine
      • Houston, Texas, États-Unis, 77089
        • Recrutement
        • Houston Pulm Med Res Network
      • San Antonio, Texas, États-Unis, 78229
        • Recrutement
        • Sleep Therapy Research Center
      • Sugar Land, Texas, États-Unis, 77478
        • Recrutement
        • Tricoastal Sleep Center
    • Washington
      • Renton, Washington, États-Unis, 98057
        • Recrutement
        • Rainier Clin Res Ctr Inc

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Placebo
Les participants recevront un placebo correspondant au NNC0487-0111 par voie sous-cutanée une fois par semaine, en complément d'un régime hypocalorique et d'une augmentation de l'activité physique.
Médicament: Placebo (apparié au NNC0487-0111)
Le placebo correspondant au NNC0487-0111 sera administré par voie sous-cutanée à l'aide de stylos injecteurs pré-remplis PDS290 sur l'une des parties du corps suivantes : cuisse, abdomen ou bras supérieur.
Expérimental: NNC0487-0111
Les participants seront randomisés pour recevoir l'un des deux niveaux de dose de NNC0487-0111 par voie sous-cutanée une fois par semaine, en complément d'un régime hypocalorique et d'une activité physique accrue.
Médicament: NNC0487-0111
Le NNC0487-0111 sera administré par voie sous-cutanée à l'aide d'injecteurs stylos pré-remplis PDS290 sur l'une des parties du corps : la cuisse, l'abdomen ou le bras supérieur.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Relative change in body weight
Délai: 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)
Délai: From baseline (week 0) to (week 80)
Measured as events/hour.
From baseline (week 0) to (week 80)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Modification du tour de taille
Délai: De la base (semaine 0) à (semaine 80)
Mesuré en centimètre (cm).
De la base (semaine 0) à (semaine 80)
Variation de la pression artérielle systolique (PAS)
Délai: Du point de départ (semaine 0) à (semaine 80)
Mesuré en millimètres de mercure (mmHg).
Du point de départ (semaine 0) à (semaine 80)
Changement de la pression artérielle diastolique (PAD)
Délai: Du départ (semaine 0) à (semaine 80)
Mesuré en mmHg.
Du départ (semaine 0) à (semaine 80)
Nombre d'effets indésirables émergents du traitement (TEAE) entraînant un arrêt définitif du traitement
Délai: De la valeur de base (semaine 0) à la semaine 84
Mesuré en tant qu'événements.
De la valeur de base (semaine 0) à la semaine 84
Relative change in AHI
Délai: 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)
Délai: 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
Délai: From baseline (week 0) to (week 80)
Measured as number of participants.
From baseline (week 0) to (week 80)
Change in ESS score
Délai: 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
Délai: 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
Délai: From baseline (week 0) to (week 80)
Measured as kilogram (Kg).
From baseline (week 0) to (week 80)
Change in body mass index (BMI)
Délai: 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)
Délai: From baseline (week 0) to (week 80)
Measured as number of participants.
From baseline (week 0) to (week 80)
Change in neck circumference
Délai: From baseline (week 0) to (week 80)
Measured as cm.
From baseline (week 0) to (week 80)
Change in Total cholesterol
Délai: 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
Délai: 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
Délai: From baseline (week 0) to (week 80)
Measured as ratio to baseline.
From baseline (week 0) to (week 80)
Change in Non-HDL cholesterol
Délai: From baseline (week 0) to (week 80)
Measured as ratio to baseline.
From baseline (week 0) to (week 80)
Change in Triglycerides
Délai: From baseline (week 0) to (week 80)
Measured as ratio to baseline.
From baseline (week 0) to (week 80)
Change in fasting plasma glucose
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: From baseline (week 0) to (week 80)
Measured as ratio to baseline.
From baseline (week 0) to (week 80)
Change in glycated haemoglobin (HbA1c)
Délai: From baseline (week 0) to (week 80)
Measured as % of HbA1c.
From baseline (week 0) to (week 80)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Novo Nordisk A/S

Les enquêteurs

  • Directeur d'études: Clinical Transparency dept. 2834, Novo Nordisk A/S

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

5 mai 2026

Achèvement primaire (Estimé)

12 juillet 2028

Achèvement de l'étude (Estimé)

4 octobre 2028

Dates d'inscription aux études

Première soumission

30 avril 2026

Première soumission répondant aux critères de contrôle qualité

30 avril 2026

Première publication (Réel)

6 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NN9490-8025
  • U1111-1313-6359 (Autre identifiant: World Health Organization (WHO))
  • 2024-520442-36 (Autre identifiant: European Medical Agency (EMA))

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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