A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
Start Date
8/21/2025
Completion Date
1/23/2037
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.
Eligibility Criteria
Age Range: 6 years to 17 years
Interventions
Enlicitide Decanoate
Placebo
Conditions
Locations
Nemours/Alfred I. duPont Hospital for Children ( Site 0001)
Wilmington, Delaware 19803
United States
Children's National Medical Center ( Site 0015)
Washington D.C., District of Columbia 20010
United States
Excel Medical Clinical Trials ( Site 0008)
Boca Raton, Florida 33434
United States
Children's Healthcare of Atlanta Cardiology ( Site 0026)
Atlanta, Georgia 30329
United States
Boston Children's Hospital ( Site 0018)
Boston, Massachusetts 02115
United States
Cincinnati Children's Hospital Medical Center ( Site 0016)
Cincinnati, Ohio 45229
United States
West Virginia University ( Site 0013)
Morgantown, West Virginia 26506
United States
Monash Children s Hospital ( Site 1603)
Clayton, Victoria 3168
Australia
UZ Antwerpen ( Site 0601)
Edegem, Antwerpen 2650
Belgium
Universidade Federal Do Ceara ( Site 0201)
Fortaleza, Ceará 60430270
Brazil
Instituto Dante Pazzanese de Cardiology ( Site 0206)
São Paulo, 04012-909
Brazil
Incor - Instituto do Coracao ( Site 0200)
São Paulo, 05403900
Brazil
Explora Salud ( Site 0304)
Santiago, Region M. de Santiago 7500504
Chile
Pontificia Universidad Catolica de Chile ( Site 0300)
Santiago, Region M. de Santiago 8330032
Chile
Beijing Anzhen Hospital. Capital Medical University ( Site 1917)
Beijing, Beijing Municipality 100029
China
Guangdong Provincial People's Hospital ( Site 1915)
Guangzhou, Guangdong 510080
China
Children's Hospital of Fudan University ( Site 1906)
Shanghai, Shanghai Municipality 200032
China
Shanghai Children's Medical Center ( Site 1918)
Shanghai, Shanghai Municipality 200120
China
The Children's Hospital of Zhejiang University School of Medicine ( Site 1905)
Hangzhou, Zhejiang 310057
China
Clinica de la Costa S.A.S. ( Site 0400)
Barranquilla, Atlántico 080020
Colombia
Oncomédica S.A.S ( Site 0401)
Montería, Departamento de Córdoba 230002
Colombia
Fundación Cardiovascular de Colombia ( Site 0402)
Piedecuesta, Santander Department 681017
Colombia
Fundacion Valle del Lili ( Site 0403)
Cali, Valle del Cauca Department 760032
Colombia
Fakultni nemocnice v Motole ( Site 0700)
Prague, 150 00
Czechia
New Childrens Hospital ( Site 0800)
Helsinki, Uusimaa 00029
Finland
Universitaetsklinikum Freiburg ( Site 2203)
Freiburg im Breisgau, Baden-Wurttemberg 79106
Germany
Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" ( Site 0501)
Monterrey, Nuevo León 64460
Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 0505)
Oaxaca City, Oaxaca 68020
Mexico
INVECORDIS S.C. ( Site 0503)
Huixquilucan, 52763
Mexico
Amsterdam UMC, locatie AMC ( Site 1000)
Amsterdam, North Holland 1105 AZ
Netherlands
New Zealand Clinical Research (Christchurch) ( Site 1700)
Christchurch, Canterbury 8011
New Zealand
National University Hospital-Paediatrics ( Site 1800)
Singapore, Central Singapore 117599
Singapore
Hospital Universitario Central de Asturias ( Site 1303)
Oviedo, Asturias, Principado de 33011
Spain
Hospital Clinico Universitario de Santiago de Compostela ( Site 1300)
Santiago de Compostela, La Coruna 15706
Spain
COMPLEJO HOSPITALARIO DE NAVARRA ( Site 1302)
Pamplona, Navarre 31009
Spain
Birmingham Childrens Hospital ( Site 1501)
Birmingham, B4 6NH
United Kingdom
Sheffield Childrens Hospital ( Site 1503)
Sheffield, S10 2TH
United Kingdom
Southampton General Hospital ( Site 1502)
Southampton, SO16 6YD
United Kingdom