A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
Recruiting now · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Heterozygous Familial Hypercholesterolemia (HeFH)
In brief
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.
Key facts
- Study ID
- NCT07058077
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 153
- Starts
- 2025-08-21
- Expected to finish
- 2037-01-23
- Last updated by the study team
- 2026-07-31
Who can join
Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Nemours/Alfred I. duPont Hospital for Children ( Site 0001) — Wilmington, Delaware, United States (enrolling)
- Children's National Medical Center ( Site 0015) — Washington D.C., District of Columbia, United States (enrolling)
- Excel Medical Clinical Trials ( Site 0008) — Boca Raton, Florida, United States (enrolling)
- Children's Healthcare of Atlanta Cardiology ( Site 0026) — Atlanta, Georgia, United States (enrolling)
- Boston Children's Hospital ( Site 0018) — Boston, Massachusetts, United States (enrolling)
- Cincinnati Children's Hospital Medical Center ( Site 0016) — Cincinnati, Ohio, United States (enrolling)
- West Virginia University ( Site 0013) — Morgantown, West Virginia, United States (enrolling)
- Monash Children s Hospital ( Site 1603) — Clayton, Victoria, Australia (enrolling)
- UZ Antwerpen ( Site 0601) — Edegem, Antwerpen, Belgium (enrolling)
- Universidade Federal Do Ceara ( Site 0201) — Fortaleza, Ceará, Brazil (enrolling)
- Instituto Dante Pazzanese de Cardiology ( Site 0206) — São Paulo, Brazil (enrolling)
- Incor - Instituto do Coracao ( Site 0200) — São Paulo, Brazil (enrolling)
- Explora Salud ( Site 0304) — Santiago, Region M. de Santiago, Chile (enrolling)
- Pontificia Universidad Catolica de Chile ( Site 0300) — Santiago, Region M. de Santiago, Chile (enrolling)
- Beijing Anzhen Hospital. Capital Medical University ( Site 1917) — Beijing, Beijing Municipality, China (enrolling)
- Guangdong Provincial People's Hospital ( Site 1915) — Guangzhou, Guangdong, China (enrolling)
- Children's Hospital of Fudan University ( Site 1906) — Shanghai, Shanghai Municipality, China (enrolling)
- Shanghai Children's Medical Center ( Site 1918) — Shanghai, Shanghai Municipality, China (enrolling)
- The Children's Hospital of Zhejiang University School of Medicine ( Site 1905) — Hangzhou, Zhejiang, China (enrolling)
- Clinica de la Costa S.A.S. ( Site 0400) — Barranquilla, Atlántico, Colombia (enrolling)
- Oncomédica S.A.S ( Site 0401) — Montería, Departamento de Córdoba, Colombia (enrolling)
- Fundación Cardiovascular de Colombia ( Site 0402) — Piedecuesta, Santander Department, Colombia (enrolling)
- Fundacion Valle del Lili ( Site 0403) — Cali, Valle del Cauca Department, Colombia (enrolling)
- Fakultni nemocnice v Motole ( Site 0700) — Prague, Czechia (enrolling)
- New Childrens Hospital ( Site 0800) — Helsinki, Uusimaa, Finland (enrolling)
Full record on ClinicalTrials.gov
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