Last updated 11 days ago
A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
153 patients around the world
Available in United States, Brazil, Colombia
Merck Sharp & Dohme LLC
6Research sites
153Patients around the world
This study is for people with
Hypercholesterolemia
Familial hypercholesterolemia
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- 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); or a nonstatin LLT with documented intolerance to at least 2 different statins or 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.
- 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 principal 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.
Sites
Instituto do Coração do HCFMUSP
Recruiting
Universidade Federal Do Ceará
Recruiting
Clínica de la Costa - Barranquilla
Recruiting
Oncomédica - IMAT - Montería, Colombia
Recruiting
Fundación Cardiovascular de Colombia
Recruiting
Fundación Valle del Lili - Colombia
Recruiting
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Familial hypercholesterolemia
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07058077
