A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants With Heterozygous Familial Hypercholesterolemia
- Heterozygous Familial Hypercholesterolemia (HeFH)
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Merck Sharp & Dohme LLC
- Enrolment target
- 153
- Started
- 21 August 2025
- Main results due
- 4 December 2033
- Study sites
- 46
- Registry updated
- 28 September 2026
Can you take part?
- Ages 6 years to 17 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: 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) * A nonstatin LLT with documented intolerance to at least 2 different statins, or documented intolerance to 1 statin plus 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: 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 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(46)
Nemours/Alfred I. duPont Hospital for Children ( Site 0001)
Wilmington, Delaware, United States
Recruiting
Children's National Medical Center ( Site 0015)
Washington D.C., District of Columbia, United States
Recruiting
Excel Medical Clinical Trials ( Site 0008)
Boca Raton, Florida, United States
Recruiting
Children's Healthcare of Atlanta Cardiology ( Site 0026)
Atlanta, Georgia, United States
Recruiting
Boston Children's Hospital ( Site 0018)
Boston, Massachusetts, United States
Recruiting
St. Louis Children's Hospital ( Site 0014)
St Louis, Missouri, United States
Recruiting
Cincinnati Children's Hospital Medical Center ( Site 0016)
Cincinnati, Ohio, United States
Recruiting
West Virginia University ( Site 0013)
Morgantown, West Virginia, United States
Recruiting
Monash Children s Hospital ( Site 1603)
Clayton, Victoria, Australia
Recruiting
Perth Children s Hospital ( Site 1601)
Nedlands, Western Australia, Australia
Recruiting
UZ Antwerpen ( Site 0601)
Edegem, Antwerpen, Belgium
Recruiting
Universidade Federal Do Ceara ( Site 0201)
Fortaleza, Ceará, Brazil
Recruiting
Instituto Dante Pazzanese de Cardiology ( Site 0206)
São Paulo, Brazil
Recruiting
Incor - Instituto do Coracao ( Site 0200)
São Paulo, Brazil
Recruiting
Biocenter ( Site 0305)
Concepción, Biobio, Chile
Recruiting
Explora Salud ( Site 0304)
Santiago, Region M. de Santiago, Chile
Recruiting
Pontificia Universidad Catolica de Chile ( Site 0300)
Santiago, Region M. de Santiago, Chile
Recruiting
Children's Hospital Capital Institute of Pediatrics ( Site 1908)
Beijing, Beijing Municipality, China
Recruiting
Beijing Anzhen Hospital. Capital Medical University ( Site 1917)
Beijing, Beijing Municipality, China
Recruiting
Guangdong Provincial People's Hospital ( Site 1915)
Guangzhou, Guangdong, China
Recruiting
Children's Hospital of Fudan University ( Site 1906)
Shanghai, Shanghai Municipality, China
Recruiting
Shanghai Children's Medical Center ( Site 1918)
Shanghai, Shanghai Municipality, China
Recruiting
The Children's Hospital of Zhejiang University School of Medicine ( Site 1905)
Hangzhou, Zhejiang, China
Recruiting
Clinica de la Costa S.A.S. ( Site 0400)
Barranquilla, Atlántico, Colombia
Recruiting
Oncomédica S.A.S ( Site 0401)
Montería, Departamento de Córdoba, Colombia
Recruiting
Fundación Cardiovascular de Colombia ( Site 0402)
Piedecuesta, Santander Department, Colombia
Recruiting
Fundacion Valle del Lili ( Site 0403)
Cali, Valle del Cauca Department, Colombia
Recruiting
Detska nemocnice FN Brno ( Site 0701)
Brno, Brno-mesto, Czechia
Recruiting
Vseobecna fakultni nemocnice v Praze ( Site 0702)
Prague, Praha 2, Czechia
Recruiting
Fakultni nemocnice v Motole ( Site 0700)
Prague, Czechia
Recruiting
New Childrens Hospital ( Site 0800)
Helsinki, Uusimaa, Finland
Recruiting
Hopital Femme Mere Enfant ( Site 2101)
Bron, Rhone, France
Recruiting
Universitaetsklinikum Freiburg ( Site 2203)
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Recruiting
Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" ( Site 0501)
Monterrey, Nuevo León, Mexico
Recruiting
Centro de Investigacion Clinica de Oaxaca ( Site 0505)
Oaxaca City, Oaxaca, Mexico
Recruiting
INVECORDIS S.C. ( Site 0503)
Huixquilucan, Mexico
Recruiting
Amsterdam UMC, locatie AMC ( Site 1000)
Amsterdam, North Holland, Netherlands
Recruiting
New Zealand Clinical Research (Christchurch) ( Site 1700)
Christchurch, Canterbury, New Zealand
Recruiting
Instytut Centrum Zdrowia Matki Polki ( Site 1201)
Lodz, Łódź Voivodeship, Poland
Recruiting
National University Hospital-Paediatrics ( Site 1800)
Singapore, Central Singapore, Singapore
Recruiting
Hospital Universitario Central de Asturias ( Site 1303)
Oviedo, Asturias, Principado de, Spain
Recruiting
Hospital Clinico Universitario de Santiago de Compostela ( Site 1300)
Santiago de Compostela, La Coruna, Spain
Recruiting
COMPLEJO HOSPITALARIO DE NAVARRA ( Site 1302)
Pamplona, Navarre, Spain
Recruiting
Birmingham Childrens Hospital ( Site 1501)
Birmingham, United Kingdom
Recruiting
Sheffield Childrens Hospital ( Site 1503)
Sheffield, United Kingdom
Recruiting
Southampton General Hospital ( Site 1502)
Southampton, United Kingdom
Recruiting
Showing 46 of 46 sites. 46 of the 46 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07058077. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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