IA Trial Radar | ||
|---|---|---|
L'essai clinique NCT07058077 pour Hypercholestérolémie Familiale Hétérozygote (HeFH) est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
Un essai clinique correspond aux filtres sélectionnés
Vue en carte
Retour à la recherche
MerckUne étude de l'Enlicitide Décanoate (MK-0616, un inhibiteur oral de PCSK9) chez des enfants et adolescents atteints d'hypercholestérolémie familiale hétérozygote (MK-0616-029) Phase II, Phase III 153 Adolescent
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07058077 est conçu pour étudier le traitement de Hypercholestérolémie Familiale Hétérozygote (HeFH). Il s'agit d'une étude interventionnel en Phase II Phase III. Son statut actuel est : en recrutement. L'étude a débuté le 21 août 2025 et vise à recruter 153 participants. Dirigée par Merck, l'étude devrait être terminée d'ici le 23 janvier 2037. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 13 mars 2026.
Résumé succinct
This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial hypercholesterolemia (HeFH) and high amounts of low-density lipoprotein cholesterol (LDL-C) in the blood.
The goals of this study are to learn about the safety of enlicitide and if children tolerate it, what happens to enlicitide in a child's body over time, and if enlicitide wor...
Afficher plusTitre officiel
An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants With Heterozygous Familial Hypercholesterolemia
Pathologies
Hypercholestérolémie Familiale Hétérozygote (HeFH)Autres identifiants de l'étude
- 0616-029
- U1111-1314-5796 (Identifiant de registre) (UTN)
- 2024-519068-42-00 (Identifiant de registre) (EU CT)
Numéro NCT
Date de début (réel)
2025-08-21
Dernière mise à jour publiée
2026-03-13
Date de fin (estimée)
2037-01-23
Inscription (estimée)
153
Type d'étude
Interventionnel
PHASE
Phase II
Phase III
Phase III
Statut
En recrutement
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Quadruple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalPart A: Enlicitide Decanoate Participants receive enlicitide decanoate orally once daily (QD) at a dosage determined by age for up to 2 weeks. | Enlicitide Decanoate Enlicitide decanoate taken by mouth |
ExpérimentalPart B: Enlicitide Decanoate Participants receive enlicitide decanoate QD at a dosage determined by age for up to 24 weeks. | Enlicitide Decanoate Enlicitide decanoate taken by mouth |
Comparateur placeboPart B: Placebo Participants receive placebo orally QD for up to 24 weeks. | PLACEBO Placebo tablet matched to enlicitide decanoate taken by mouth |
ExpérimentalOpen-Label Extension: Enlicitide Decanoate Participants who complete either Part A or Part B may enroll in this open-label extension arm. Participants in the extension arm receive enlicitide decanoate QD at a dosage determined by age for up to 3 years. | Enlicitide Decanoate Enlicitide decanoate taken by mouth |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Part A: Maximum Plasma Concentration (Cmax) of Enlicitide | Blood samples will be collected to determine the Cmax of enlicitide. | At designated timepoints (up to 24 hours postdose on day 14) |
Part A: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide | Blood samples will be collected to determine the AUC0-24 of enlicitide. | At designated timepoints (up to 24 hours postdose on day 14) |
Part B: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) | Blood samples will be collected to determine the percent change from baseline in LDL-C. | Baseline and Week 24 |
Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 188 weeks |
Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 180 weeks |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Part B: Percent Change from Baseline in Apolipoprotein B (ApoB) | Blood samples will be collected to determine the percent change from baseline in apolipoprotein B. | Baseline and week 24 |
Part B: Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C) | Blood samples will be collected to determine the percent change from baseline in non-HDL-C. | Baseline and week 24 |
Part B: Percent Change from Baseline in Lipoprotein (a) (Lp(a)) | Blood samples will be collected to determine the percent change from baseline in Lp(a). | Baseline and week 24 |
Part B: Percentage of Participants With LDL-C <130 mg/dL at Week 24 | The percentage of participants with LDL-C \<130 mg/dL at week 24 will be reported. | Week 24 |
Part B: Percentage of Participants With ≥50% LDL-C LDL-C Reduction from Baseline at Week 24 | The percentage of participants with ≥50% LDL-C reduction from baseline at week 24 will be reported. | Baseline and week 24 |
Part B: Percentage of Participants With LDL-C <100 mg/dL at Week 24 | The percentage of participants with LDL-C \<100 mg/dL at week 24 will be reported. | Week 24 |
Change in Carotid Intima-media Thickness (cIMT) | Ultrasound measurements will be performed to determine the change from baseline in cIMT. | Baseline and week 24 |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Enfant
Âge minimum
6 Years
Sexes éligibles
Tous
Inclusion criteria include, but are not limited to:
- Has possible or definite diagnosis of HeFH based on a locally accepted diagnostic algorithm or diagnosis by genetic testing results
- Has a fasted LDL-C value (evaluated by the central laboratory) that is ≥130 mg/dL
- Is receiving either an optimized daily dose of statin (± nonstatin LLT); or a nonstatin LLT with documented intolerance to at least 2 different statins or refusal of statin therapy by the participant or legally acceptable representative
- Is on a stable dose of all background LLTs for at least 30 days prior to screening, with no medication or dose changes planned during participation in Part A or Part B
Exclusion criteria include, but are not limited to:
- Has a history of homozygous FH based on genetic or clinical criteria, or history of known compound heterozygous FH, or double heterozygous FH
- Has a history of nephrotic syndrome
- Has any clinically significant malabsorption condition based on principal investigator assessment
- Was previously treated/is being treated with certain other cholesterol lowering medications, including proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout
MerckContact central de l'étude
Contact: Toll Free Number, 1-888-577-8839, [email protected]
21 Centres de l'étude dans 12 pays
Antwerpen
UZ Antwerpen ( Site 0601), Edegem, Antwerpen, 2650, Belgium
Study Coordinator, Contact, +323 821 32 51
En recrutement
Delaware
Nemours/Alfred I. duPont Hospital for Children ( Site 0001), Wilmington, Delaware, 19803, United States
Study Coordinator, Contact, 302-651-6600
En recrutement
District of Columbia
Children's National Medical Center ( Site 0015), Washington D.C., District of Columbia, 20010, United States
Study Coordinator, Contact, 202-476-5000
En recrutement
Florida
Excel Medical Clinical Trials ( Site 0008), Boca Raton, Florida, 33434, United States
Study Coordinator, Contact, 561-529-4356
En recrutement
Georgia
Children's Healthcare of Atlanta Cardiology ( Site 0026), Atlanta, Georgia, 30329, United States
Study Coordinator, Contact, 404-256-2593
En recrutement
Victoria
Monash Children s Hospital ( Site 1603), Clayton, Victoria, 3168, Australia
Study Coordinator, Contact, +61385723000
En recrutement
Ceará
Universidade Federal Do Ceara ( Site 0201), Fortaleza, Ceará, 60430270, Brazil
Study Coordinator, Contact, +558533668590
En recrutement
Incor - Instituto do Coracao ( Site 0200), São Paulo, 05403900, Brazil
Study Coordinator, Contact, +551126615450
En recrutement
Beijing Municipality
Beijing Anzhen Hospital. Capital Medical University ( Site 1917), Beijing, Beijing Municipality, 100029, China
Study Coordinator, Contact, 010-64412431
En recrutement
Zhejiang
The Children's Hospital of Zhejiang University School of Medicine ( Site 1905), Hangzhou, Zhejiang, 310057, China
Study Coordinator, Contact, 0571-86036545
En recrutement
Atlántico
Clinica de la Costa S.A.S. ( Site 0400), Barranquilla, Atlántico, 080020, Colombia
Study Coordinator, Contact, +57 3133894240
En recrutement
Departamento de Córdoba
Oncomédica S.A.S ( Site 0401), Montería, Departamento de Córdoba, 230002, Colombia
Study Coordinator, Contact, +57 3135342052
En recrutement
Santander Department
Fundación Cardiovascular de Colombia ( Site 0402), Piedecuesta, Santander Department, 681017, Colombia
Study Coordinator, Contact, +573203400438
En recrutement
Valle del Cauca Department
Fundacion Valle del Lili ( Site 0403), Cali, Valle del Cauca Department, 760032, Colombia
Study Coordinator, Contact, +573166237452
En recrutement
Uusimaa
New Childrens Hospital ( Site 0800), Helsinki, Uusimaa, 00029, Finland
Study Coordinator, Contact, +358 9 4711
En recrutement
North Holland
Amsterdam UMC, locatie AMC ( Site 1000), Amsterdam, North Holland, 1105 AZ, Netherlands
Study Coordinator, Contact, +31205666360
En recrutement
Canterbury
New Zealand Clinical Research (Christchurch) ( Site 1700), Christchurch, Canterbury, 8011, New Zealand
Study Coordinator, Contact, NZCR +6433729477
En recrutement
Central Singapore
National University Hospital-Paediatrics ( Site 1800), Singapore, Central Singapore, 117599, Singapore
Study Coordinator, Contact, +6567795555
En recrutement
Asturias, Principado de
Hospital Universitario Central de Asturias ( Site 1303), Oviedo, Asturias, Principado de, 33011, Spain
Study Coordinator, Contact, +34985108000
En recrutement
Navarre
COMPLEJO HOSPITALARIO DE NAVARRA ( Site 1302), Pamplona, Navarre, 31009, Spain
Study Coordinator, Contact, +34660021505
En recrutement
Sheffield Childrens Hospital ( Site 1503), Sheffield, S10 2TH, United Kingdom
Study Coordinator, Contact, +441142717000
En recrutement