Actively Recruiting
A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-11
153
Participants Needed
26
Research Sites
596 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH) by accepted algorithm or genetic testing
- Fasting LDL cholesterol (LDL-C) of 130 mg/dL or higher
- Receiving optimized daily statin dose with or without nonstatin lipid-lowering therapy, or nonstatin therapy with statin intolerance or refusal
- Stable dose of all background lipid-lowering therapies for at least 30 days before screening without planned changes during study
You will not qualify if you...
- History of homozygous familial hypercholesterolemia or compound/double heterozygous FH
- History of nephrotic syndrome
- Any clinically significant malabsorption condition
- Prior or current treatment with certain cholesterol-lowering drugs including PCSK9 inhibitors without adequate washout
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
Nemours/Alfred I. duPont Hospital for Children ( Site 0001)
Wilmington, Delaware, United States, 19803
Actively Recruiting
2
Children's National Medical Center ( Site 0015)
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
3
Excel Medical Clinical Trials ( Site 0008)
Boca Raton, Florida, United States, 33434
Actively Recruiting
4
Children's Healthcare of Atlanta Cardiology ( Site 0026)
Atlanta, Georgia, United States, 30329
Actively Recruiting
5
Cincinnati Children's Hospital Medical Center ( Site 0016)
Cincinnati, Ohio, United States, 45229
Actively Recruiting
6
West Virginia University ( Site 0013)
Morgantown, West Virginia, United States, 26506
Actively Recruiting
7
Monash Children s Hospital ( Site 1603)
Clayton, Victoria, Australia, 3168
Actively Recruiting
8
UZ Antwerpen ( Site 0601)
Edegem, Antwerpen, Belgium, 2650
Actively Recruiting
9
Universidade Federal Do Ceara ( Site 0201)
Fortaleza, Ceará, Brazil, 60430270
Actively Recruiting
10
Incor - Instituto do Coracao ( Site 0200)
São Paulo, Brazil, 05403900
Actively Recruiting
11
Beijing Anzhen Hospital. Capital Medical University ( Site 1917)
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
12
Shanghai Children's Medical Center ( Site 1918)
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
13
The Children's Hospital of Zhejiang University School of Medicine ( Site 1905)
Hangzhou, Zhejiang, China, 310057
Actively Recruiting
14
Clinica de la Costa S.A.S. ( Site 0400)
Barranquilla, Atlántico, Colombia, 080020
Actively Recruiting
15
Oncomédica S.A.S ( Site 0401)
Montería, Departamento de Córdoba, Colombia, 230002
Actively Recruiting
16
Fundación Cardiovascular de Colombia ( Site 0402)
Piedecuesta, Santander Department, Colombia, 681017
Actively Recruiting
17
Fundacion Valle del Lili ( Site 0403)
Cali, Valle del Cauca Department, Colombia, 760032
Actively Recruiting
18
New Childrens Hospital ( Site 0800)
Helsinki, Uusimaa, Finland, 00029
Actively Recruiting
19
Amsterdam UMC, locatie AMC ( Site 1000)
Amsterdam, North Holland, Netherlands, 1105 AZ
Actively Recruiting
20
New Zealand Clinical Research (Christchurch) ( Site 1700)
Christchurch, Canterbury, New Zealand, 8011
Actively Recruiting
21
National University Hospital-Paediatrics ( Site 1800)
Singapore, Central Singapore, Singapore, 117599
Actively Recruiting
22
Hospital Universitario Central de Asturias ( Site 1303)
Oviedo, Asturias, Principado de, Spain, 33011
Actively Recruiting
23
Hospital Clinico Universitario de Santiago de Compostela ( Site 1300)
Santiago de Compostela, La Coruna, Spain, 15706
Actively Recruiting
24
COMPLEJO HOSPITALARIO DE NAVARRA ( Site 1302)
Pamplona, Navarre, Spain, 31009
Actively Recruiting
25
Birmingham Childrens Hospital ( Site 1501)
Birmingham, United Kingdom, B4 6NH
Actively Recruiting
26
Sheffield Childrens Hospital ( Site 1503)
Sheffield, United Kingdom, S10 2TH
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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