Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
Sponsor: Merck Sharp & Dohme LLC
Summary
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 works to lower cholesterol levels in children more than a placebo.
Official title: An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants With Heterozygous Familial Hypercholesterolemia
Key Details
Gender
All
Age Range
6 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
153
Start Date
2025-08-21
Completion Date
2037-01-23
Last Updated
2026-03-13
Healthy Volunteers
No
Interventions
Enlicitide Decanoate
Enlicitide decanoate taken by mouth
Placebo
Placebo tablet matched to enlicitide decanoate taken by mouth
Locations (21)
Nemours/Alfred I. duPont Hospital for Children ( Site 0001)
Wilmington, Delaware, United States
Children's National Medical Center ( Site 0015)
Washington D.C., District of Columbia, United States
Excel Medical Clinical Trials ( Site 0008)
Boca Raton, Florida, United States
Children's Healthcare of Atlanta Cardiology ( Site 0026)
Atlanta, Georgia, United States
Monash Children s Hospital ( Site 1603)
Clayton, Victoria, Australia
UZ Antwerpen ( Site 0601)
Edegem, Antwerpen, Belgium
Universidade Federal Do Ceara ( Site 0201)
Fortaleza, Ceará, Brazil
Incor - Instituto do Coracao ( Site 0200)
São Paulo, Brazil
Beijing Anzhen Hospital. Capital Medical University ( Site 1917)
Beijing, Beijing Municipality, China
The Children's Hospital of Zhejiang University School of Medicine ( Site 1905)
Hangzhou, Zhejiang, China
Clinica de la Costa S.A.S. ( Site 0400)
Barranquilla, Atlántico, Colombia
Oncomédica S.A.S ( Site 0401)
Montería, Departamento de Córdoba, Colombia
Fundación Cardiovascular de Colombia ( Site 0402)
Piedecuesta, Santander Department, Colombia
Fundacion Valle del Lili ( Site 0403)
Cali, Valle del Cauca Department, Colombia
New Childrens Hospital ( Site 0800)
Helsinki, Uusimaa, Finland
Amsterdam UMC, locatie AMC ( Site 1000)
Amsterdam, North Holland, Netherlands
New Zealand Clinical Research (Christchurch) ( Site 1700)
Christchurch, Canterbury, New Zealand
National University Hospital-Paediatrics ( Site 1800)
Singapore, Central Singapore, Singapore
Hospital Universitario Central de Asturias ( Site 1303)
Oviedo, Asturias, Principado de, Spain
COMPLEJO HOSPITALARIO DE NAVARRA ( Site 1302)
Pamplona, Navarre, Spain
Sheffield Childrens Hospital ( Site 1503)
Sheffield, United Kingdom