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El ensayo clínico NCT07058077 para Hipercolesterolemia Familiar Heterocigota (HeFH) está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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MerckA Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029) Fase II, Fase III 153 Adolescentes
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07058077 está diseñado para estudiar el tratamiento de Hipercolesterolemia Familiar Heterocigota (HeFH). Es un estudio intervencionista de Fase II Fase III. Su estado actual es: reclutando. El estudio se inició el 21 de agosto de 2025, con el objetivo de reclutar a 153 participantes. Dirigido por Merck, se espera que finalice el 23 de enero de 2037. Los datos se actualizaron por última vez en ClinicalTrials.gov el 13 de marzo de 2026.
Resumen
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...
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An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants With Heterozygous Familial Hypercholesterolemia
Condiciones médicas
Hipercolesterolemia Familiar Heterocigota (HeFH)Otros ID del estudio
- 0616-029
- U1111-1314-5796 (Identificador de registro) (UTN)
- 2024-519068-42-00 (Identificador de registro) (EU CT)
Número del NCT
Inicio del estudio (real)
2025-08-21
Última actualización
2026-03-13
Fecha de finalización (estimada)
2037-01-23
Inscripción (prevista)
153
Tipo de estudio
Intervencionista
FASE
Fase II
Fase III
Fase III
Estado general
Reclutando
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Cuádruple ciego
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalPart 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 |
ExperimentalPart 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 |
Comparador placeboPart B: Placebo Participants receive placebo orally QD for up to 24 weeks. | PLACEBO Placebo tablet matched to enlicitide decanoate taken by mouth |
ExperimentalOpen-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 |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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 |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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 |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Niño
Edad mínima
6 Years
Criterios de sexo
Todos
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
MerckContactos centrales del estudio
Contacto: Toll Free Number, 1-888-577-8839, [email protected]
21 Centros del estudio en 12 países
Asturias, Principado de
Hospital Universitario Central de Asturias ( Site 1303), Oviedo, Asturias, Principado de, 33011, Spain
Study Coordinator, Contacto, +34985108000
Reclutando
Navarre
COMPLEJO HOSPITALARIO DE NAVARRA ( Site 1302), Pamplona, Navarre, 31009, Spain
Study Coordinator, Contacto, +34660021505
Reclutando
Atlántico
Clinica de la Costa S.A.S. ( Site 0400), Barranquilla, Atlántico, 080020, Colombia
Study Coordinator, Contacto, +57 3133894240
Reclutando
Departamento de Córdoba
Oncomédica S.A.S ( Site 0401), Montería, Departamento de Córdoba, 230002, Colombia
Study Coordinator, Contacto, +57 3135342052
Reclutando
Santander Department
Fundación Cardiovascular de Colombia ( Site 0402), Piedecuesta, Santander Department, 681017, Colombia
Study Coordinator, Contacto, +573203400438
Reclutando
Valle del Cauca Department
Fundacion Valle del Lili ( Site 0403), Cali, Valle del Cauca Department, 760032, Colombia
Study Coordinator, Contacto, +573166237452
Reclutando
Delaware
Nemours/Alfred I. duPont Hospital for Children ( Site 0001), Wilmington, Delaware, 19803, United States
Study Coordinator, Contacto, 302-651-6600
Reclutando
District of Columbia
Children's National Medical Center ( Site 0015), Washington D.C., District of Columbia, 20010, United States
Study Coordinator, Contacto, 202-476-5000
Reclutando
Florida
Excel Medical Clinical Trials ( Site 0008), Boca Raton, Florida, 33434, United States
Study Coordinator, Contacto, 561-529-4356
Reclutando
Georgia
Children's Healthcare of Atlanta Cardiology ( Site 0026), Atlanta, Georgia, 30329, United States
Study Coordinator, Contacto, 404-256-2593
Reclutando
Victoria
Monash Children s Hospital ( Site 1603), Clayton, Victoria, 3168, Australia
Study Coordinator, Contacto, +61385723000
Reclutando
Antwerpen
UZ Antwerpen ( Site 0601), Edegem, Antwerpen, 2650, Belgium
Study Coordinator, Contacto, +323 821 32 51
Reclutando
Ceará
Universidade Federal Do Ceara ( Site 0201), Fortaleza, Ceará, 60430270, Brazil
Study Coordinator, Contacto, +558533668590
Reclutando
Incor - Instituto do Coracao ( Site 0200), São Paulo, 05403900, Brazil
Study Coordinator, Contacto, +551126615450
Reclutando
Beijing Municipality
Beijing Anzhen Hospital. Capital Medical University ( Site 1917), Beijing, Beijing Municipality, 100029, China
Study Coordinator, Contacto, 010-64412431
Reclutando
Zhejiang
The Children's Hospital of Zhejiang University School of Medicine ( Site 1905), Hangzhou, Zhejiang, 310057, China
Study Coordinator, Contacto, 0571-86036545
Reclutando
Uusimaa
New Childrens Hospital ( Site 0800), Helsinki, Uusimaa, 00029, Finland
Study Coordinator, Contacto, +358 9 4711
Reclutando
North Holland
Amsterdam UMC, locatie AMC ( Site 1000), Amsterdam, North Holland, 1105 AZ, Netherlands
Study Coordinator, Contacto, +31205666360
Reclutando
Canterbury
New Zealand Clinical Research (Christchurch) ( Site 1700), Christchurch, Canterbury, 8011, New Zealand
Study Coordinator, Contacto, NZCR +6433729477
Reclutando
Central Singapore
National University Hospital-Paediatrics ( Site 1800), Singapore, Central Singapore, 117599, Singapore
Study Coordinator, Contacto, +6567795555
Reclutando
Sheffield Childrens Hospital ( Site 1503), Sheffield, S10 2TH, United Kingdom
Study Coordinator, Contacto, +441142717000
Reclutando