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RECRUITING Phase 2 / Phase 3 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT07058077

Registry updated: 2026-10-07
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Description

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.

Interventions

  • Enlicitide Decanoate (Drug)
    Enlicitide decanoate taken by mouth
  • Placebo (Drug)
    Placebo tablet matched to enlicitide decanoate taken by mouth

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

Conditions

Heterozygous Familial Hypercholesterolemia (HeFH)

Locations

  • 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
  • Boston Children's Hospital ( Site 0018) — Boston, Massachusetts, United States
  • St. Louis Children's Hospital ( Site 0014) — St Louis, Missouri, United States
  • Cincinnati Children's Hospital Medical Center ( Site 0016) — Cincinnati, Ohio, United States
  • West Virginia University ( Site 0013) — Morgantown, West Virginia, United States
  • Monash Children s Hospital ( Site 1603) — Clayton, Victoria, Australia
  • Perth Children s Hospital ( Site 1601) — Nedlands, Western Australia, Australia
  • UZ Antwerpen ( Site 0601) — Edegem, Antwerpen, Belgium
  • Universidade Federal Do Ceara ( Site 0201) — Fortaleza, Ceará, Brazil
  • Instituto Dante Pazzanese de Cardiology ( Site 0206) — São Paulo, Brazil
  • Incor - Instituto do Coracao ( Site 0200) — São Paulo, Brazil
  • Biocenter ( Site 0305) — Concepción, Biobio, Chile
  • Explora Salud ( Site 0304) — Santiago, Region M. de Santiago, Chile
  • Pontificia Universidad Catolica de Chile ( Site 0300) — Santiago, Region M. de Santiago, Chile
  • Children's Hospital Capital Institute of Pediatrics ( Site 1908) — Beijing, Beijing Municipality, China
  • Beijing Anzhen Hospital. Capital Medical University ( Site 1917) — Beijing, Beijing Municipality, China
  • Guangdong Provincial People's Hospital ( Site 1915) — Guangzhou, Guangdong, China
  • Children's Hospital of Fudan University ( Site 1906) — Shanghai, Shanghai Municipality, China
  • Shanghai Children's Medical Center ( Site 1918) — Shanghai, Shanghai 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
  • Detska nemocnice FN Brno ( Site 0701) — Brno, Brno-mesto, Czechia
  • Vseobecna fakultni nemocnice v Praze ( Site 0702) — Prague, Praha 2, Czechia
  • Fakultni nemocnice v Motole ( Site 0700) — Prague, Czechia
  • New Childrens Hospital ( Site 0800) — Helsinki, Uusimaa, Finland
  • Hopital Femme Mere Enfant ( Site 2101) — Bron, Rhone, France
  • Universitaetsklinikum Freiburg ( Site 2203) — Freiburg im Breisgau, Baden-Wurttemberg, Germany
  • Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" ( Site 0501) — Monterrey, Nuevo León, Mexico
  • Centro de Investigacion Clinica de Oaxaca ( Site 0505) — Oaxaca City, Oaxaca, Mexico
  • INVECORDIS S.C. ( Site 0503) — Huixquilucan, Mexico
  • Amsterdam UMC, locatie AMC ( Site 1000) — Amsterdam, North Holland, Netherlands
  • New Zealand Clinical Research (Christchurch) ( Site 1700) — Christchurch, Canterbury, New Zealand
  • Oslo Universitetssykehus Aker-Lipidklinikken ( Site 1100) — Oslo, Norway
  • Instytut Centrum Zdrowia Matki Polki ( Site 1201) — Lodz, Łódź Voivodeship, Poland
  • National University Hospital-Paediatrics ( Site 1800) — Singapore, Central Singapore, Singapore
  • Hospital Universitario Central de Asturias ( Site 1303) — Oviedo, Asturias, Principado de, Spain
  • Hospital Clinico Universitario de Santiago de Compostela ( Site 1300) — Santiago de Compostela, La Coruna, Spain
  • COMPLEJO HOSPITALARIO DE NAVARRA ( Site 1302) — Pamplona, Navarre, Spain
  • Birmingham Childrens Hospital ( Site 1501) — Birmingham, United Kingdom
  • Sheffield Childrens Hospital ( Site 1503) — Sheffield, United Kingdom
  • Southampton General Hospital ( Site 1502) — Southampton, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record