AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 2, Phase 3Ages 6 Years - 17 YearsAllMerck Sharp & Dohme LLC
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ130 mg/dL * Is receiving either: * An optimized daily dose of statin (ยฑ 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
๐Ÿ’Š

What it tests

  • Enlicitide Decanoate
  • Placebo
๐Ÿ“

Where

47 sites
Nemours/Alfred I. duPont Hospital for Children ( Site 0001)
Wilmington, United States
Children's National Medical Center ( Site 0015)
Washington D.C., United States
Excel Medical Clinical Trials ( Site 0008)
Boca Raton, United States
Children's Healthcare of Atlanta Cardiology ( Site 0026)
Atlanta, United States
Boston Children's Hospital ( Site 0018)
Boston, United States
St. Louis Children's Hospital ( Site 0014)
St Louis, United States
Cincinnati Children's Hospital Medical Center ( Site 0016)
Cincinnati, United States
West Virginia University ( Site 0013)
Morgantown, United States

โ€ฆand 39 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy