- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07225816
Examen de la manière dont la durée du jeûne et l'arrêt temporaire des médicaments GLP-1 affectent la quantité de nourriture restant dans l'estomac chez les personnes utilisant le liraglutide (injecté), le sémaglutide (pris par voie orale) ou le sémaglutide (injecté)
Étude de l'effet de la durée du jeûne et de la suspension temporaire des agonistes des récepteurs du GLP-1 sur le contenu gastrique résiduel chez les participants traités par liraglutide sous-cutané, sémaglutide oral ou sémaglutide sous-cutané
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Novo Nordisk
- Numéro de téléphone: (+1) 866-867-7178
- E-mail: clinicaltrials@novonordisk.com
Lieux d'étude
-
-
California
-
Cypress, California, États-Unis, 90630
- Recrutement
- Altasciences Clinical LA, Inc.
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Critères d'inclusion :
- Sous traitement d'entretien avec soit du liraglutide 3,0 milligramme (mg) pendant au moins 5 jours, du sémaglutide oral 14 mg (formulation R1) ou 9 mg (formulation R2) pendant au moins 5 semaines, ou du sémaglutide 2,4 mg pendant au moins 5 semaines avant le dépistage.
Critères d'exclusion :
- Déjà inclus dans cette étude.
- Déjà re-dépisté pour cette étude.
- Femme enceinte, allaitante ou ayant l'intention de devenir enceinte ou en âge de procréer et n'utilisant pas une méthode contraceptive adéquate.
- Participation actuelle (c'est-à-dire, consentement éclairé signé) à toute autre étude clinique interventionnelle.
- Exposition à des produits médicinaux expérimentaux, sauf le traitement d'entretien avec du liraglutide 3,0 mg, du sémaglutide oral 9 ou 14 mg, ou du sémaglutide 2,4 mg comme requis par le critère d'inclusion, dans les 30 jours ou 5 demi-vies du produit médicamenteux expérimental (si connu), la période la plus longue étant retenue, avant le dépistage (Visite 1).
- Toute condition qui, de l'avis de l'investigateur, pourrait compromettre la sécurité du participant ou sa conformité au protocole.
- Changement anticipé du mode de vie (par exemple, alimentation, exercice ou habitudes de sommeil) pendant l'étude.
- Le participant est l'investigateur ou un autre membre du personnel du site ou un parent de ceux-ci directement impliqué dans la conduite de l'étude.
- Incapacité mentale, barrières linguistiques ou refus de se conformer aux exigences du protocole, pouvant compromettre la compréhension ou la coopération pendant l'étude, selon l'appréciation de l'investigateur.
- Présence de troubles gastro-intestinaux cliniquement significatifs ou de symptômes de troubles gastro-intestinaux susceptibles d'affecter l'absorption des médicaments ou des nutriments, ou selon l'appréciation de l'investigateur.
- Antécédents d'interventions chirurgicales majeures impliquant l'œsophage ou l'estomac susceptibles d'affecter l'absorption des produits de l'essai (par exemple, gastrectomie subtotale et totale, gastrectomie longitudinale, chirurgie de pontage gastrique) ou présence actuelle d'implant gastro-intestinal a*.
- Insuffisance rénale avec un débit de filtration glomérulaire estimé (DFGe) inférieur à (<) 30 millilitre par minute par 1,73 mètre carré (ml/min/1,73 m²) au dépistage basé sur l'équation de créatinine de la Collaboration épidémiologique de la maladie rénale chronique (CKD-EPI) selon les critères KDIGO 2024.
- Traitement actuel avec de l'insuline ou des sécrétagogues pouvant causer une hypoglycémie pendant les périodes de jeûne.
- Antécédents d'acidocétose.
- Diagnostiqué ou suspecté de souffrir de gastroparesie, de hernie hiatale ou de reflux gastro-œsophagien sévère avec des symptômes quotidiens et/ou en position couchée.
- Utilisation d'autres médicaments connus pour affecter la motilité de l'estomac.
- Incapacité à s'allonger en décubitus latéral droit pour l'échographie gastrique.
Habitudes alimentaires inhabituelles et besoins diététiques spéciaux ou refus de manger les repas fournis dans l'étude.
- Tel que déclaré par le participant ou rapporté dans les dossiers médicaux.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Liraglutide
Les participants recevront du liraglutide par voie sous-cutanée.
|
Les participants recevront du liraglutide par voie sous-cutanée.
|
|
Expérimental: Sémaglutide oral
Les participants recevront du sémaglutide par voie orale.
|
Les participants recevront du sémaglutide par voie orale.
|
|
Expérimental: Sémaglutide
Les participants recevront du sémaglutide par voie sous-cutanée.
|
Les participants recevront du sémaglutide par voie sous-cutanée.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal after dosing of subcutaneous (s.c.) liraglutide once daily (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal after dosing of oral semaglutide once daily (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal after dosing of s.c. semaglutide once weekly (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Gastric volume after fasting following a solid, high-fat meal after dosing of s.c. liraglutide once daily
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40
|
Measured as milliliters per kilogram (mL/kg).
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40
|
|
Gastric volume after fasting following a solid, high-fat meal after dosing of oral semaglutide once daily
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161
|
Measured as mL/kg.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161
|
|
Gastric volume after fasting following a solid, high-fat meal after dosing of s.c. semaglutide once weekly
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141
|
Measured as mL/kg.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal after dosing of s.c. liraglutide once daily (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal after dosing of oral semaglutide once daily (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal after dosing of s.c. semaglutide once weekly (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a liquid meal after dosing of s.c. liraglutide once daily (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44
|
Measured as count of participants
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a liquid meal after dosing of oral semaglutide once daily (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a liquid meal after dosing of s.c. semaglutide once weekly (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148
|
|
Gastric volume after fasting following liquid meal after dosing of s.c. liraglutide once daily
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44
|
Measured as mL/kg
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44
|
|
Gastric volume after fasting following liquid meal after dosing of oral semaglutide once daily
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165
|
Measured as mL/kg
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165
|
|
Gastric volume after fasting following a liquid meal after dosing of s.c. semaglutide once weekly
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148
|
Measured as mL/kg
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a liquid meal after dosing of s.c. liraglutide once daily (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44
|
Measured as count of participants
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a liquid meal after dosing of oral semaglutide once daily (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165
|
Measured as count of participants
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a liquid meal after dosing of s.c. semaglutide once weekly (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148
|
Measured as count of participants
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal 1 day after dosing of s.c. liraglutide once daily (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 48
|
Measured as count of participants
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 48
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal 7 days after dosing of oral semaglutide once daily (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171
|
Measured as count of participants
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal 14 days after dosing of oral semaglutide once daily (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178
|
Measured as count of participants
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal 7 days after dosing of s.c. semaglutide once weekly (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 9, Day 153
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 9, Day 153
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal 14 days after dosing of s.c. semaglutide once weekly (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160
|
|
Gastric volume after fasting following a solid, high-fat meal 1 day after dosing of s.c. liraglutide once daily
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 48
|
Measured as mL/kg
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 48
|
|
Gastric volume after fasting following a solid, high-fat meal 7 days after dosing of oral semaglutide once daily
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171
|
Measured as mL/kg
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171
|
|
Gastric volume after fasting following a solid, high-fat meal 14 days after dosing of oral semaglutide once daily
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178
|
Measured as mL/kg
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178
|
|
Gastric volume after fasting following a solid, high-fat meal 7 days after dosing of s.c. semaglutide once weekly
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 9, Day 153
|
Measured as mL/kg
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 9, Day 153
|
|
Gastric volume after fasting following a solid, high-fat meal 14 days after dosing of s.c. semaglutide once weekly
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160
|
Measured as mL/kg
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal 1 day after dosing of s.c. liraglutide once daily (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 48
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 48
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal 7 days after dosing of oral semaglutide once daily (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal 14 days after dosing of oral semaglutide once daily (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal 7 days after dosing of s.c. semaglutide once weekly (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 9, Day 153
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 9, Day 153
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal 14 days after dosing of s.c. semaglutide 2.4 mg once weekly (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1
|
|
Gastric volume after fasting following a solid, high-fat meal
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1
|
Measured as mL/kg.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a liquid meal (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5
|
|
Gastric volume after fasting following a liquid meal
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5
|
Measured as mL/kg
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a liquid meal (Yes/No)
Délai: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Troubles nutritionnels
- Suralimentation
- Poids
- En surpoids
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Signes et symptômes
- Obésité
- Hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Hormones gastro-intestinales
- Peptides de type glucagon
- Progcagon
- Peptide de type glucagon 1
- Liraglutide
- sémaglutide
Autres numéros d'identification d'étude
- NN9536-8438
- U1111-1323-7355 (Autre identifiant: World Health Organization (WHO))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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