Tests enlicitide decanoate to lower cholesterol in children with familial high cholesterol
Tests enlicitide decanoate against a placebo in children with inherited high cholesterol.
Plain-language title generated from the registry record
Registry title: A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
Key facts
- Where
- Atlanta, Boca Raton, Boston, Cincinnati, Morgantown, St Louis, Washington D.C., and Wilmington, United StatesSee the 8 sites
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 17 years old?
Source: NCT07058077, who can take part
Where in United States
- Children's Healthcare of Atlanta Cardiology (Site 0026)Atlanta, United StatesTaking people
- Excel Medical Clinical Trials (Site 0008)Boca Raton, United StatesTaking people
- Boston Children's Hospital (Site 0018)Boston, United StatesTaking people
- Cincinnati Children's Hospital Medical Center (Site 0016)Cincinnati, United StatesTaking people
- West Virginia University (Site 0013)Morgantown, United StatesTaking people
- St. Louis Children's Hospital (Site 0014)St Louis, United StatesTaking people
- Children's National Medical Center (Site 0015)Washington D.C., United StatesTaking people
- Nemours/Alfred I. duPont Hospital for Children (Site 0001)Wilmington, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT07058077EU 2024-519068-42-00
- Record updated
- 10 November 2026
- Original 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.Read full original descriptionShow less
An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants With Heterozygous Familial Hypercholesterolemia
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.
Inclusion: 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: Was previously treated/is being treated with certain other cholesterol lowering medications, including proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout; 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.