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A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

NCT07058077

RecruitingPhase 2, Phase 3

Sponsor: Merck Sharp & Dohme LLC

Conditions: Heterozygous Familial Hypercholesterolemia (HeFH)

Interventions: Enlicitide Decanoate, Placebo

Countries: United States, Australia, Belgium, Brazil, Chile, China, Colombia, Finland

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 overview

Sex: ALL

Age: 6 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (36)
  • Wilmington, Delaware, United States
  • Washington D.C., District of Columbia, United States
  • Boca Raton, Florida, United States
  • Atlanta, Georgia, United States
  • Boston, Massachusetts, United States
  • Cincinnati, Ohio, United States
  • Morgantown, West Virginia, United States
  • Clayton, Victoria, Australia
  • Edegem, Antwerpen, Belgium
  • Fortaleza, Ceará, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • Santiago, Region M. de Santiago, Chile
  • Santiago, Region M. de Santiago, Chile
  • Beijing, Beijing Municipality, China
  • Shanghai, Shanghai Municipality, China
  • Shanghai, Shanghai Municipality, China
  • Hangzhou, Zhejiang, China
  • Barranquilla, Atlántico, Colombia
  • Montería, Departamento de Córdoba, Colombia
  • Piedecuesta, Santander Department, Colombia
  • Cali, Valle del Cauca Department, Colombia
  • Helsinki, Uusimaa, Finland
  • Freiburg im Breisgau, Baden-Wurttemberg, Germany
  • Monterrey, Nuevo León, Mexico
  • Oaxaca City, Oaxaca, Mexico
  • Huixquilucan, Mexico
  • Amsterdam, North Holland, Netherlands
  • Christchurch, Canterbury, New Zealand
  • Singapore, Central Singapore, Singapore
  • + 6 more on CT.gov