A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
Recruiting · NCT07058077 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
Enlicitide DecanoatePlacebo
What this trial is about
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.
Who can take part
Age range
6 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
43 locations listed across 7 US states.
- Nemours/Alfred I. duPont Hospital for Children ( Site 0001) - Wilmington, Delaware, United States
- Children's National Medical Center ( Site 0015) - Washington D.C., District of Columbia, United States
- Excel Medical Clinical Trials ( Site 0008) - Boca Raton, Florida, United States
- Children's Healthcare of Atlanta Cardiology ( Site 0026) - Atlanta, Georgia, United States
- Boston Children's Hospital ( Site 0018) - Boston, Massachusetts, United States
- Cincinnati Children's Hospital Medical Center ( Site 0016) - Cincinnati, Ohio, United States
- West Virginia University ( Site 0013) - Morgantown, West Virginia, United States
- Birmingham Childrens Hospital ( Site 1501) - Birmingham, United Kingdom
- INVECORDIS S.C. ( Site 0503) - Huixquilucan, Mexico
- Fakultni nemocnice v Motole ( Site 0700) - Prague, Czechia
- Sheffield Childrens Hospital ( Site 1503) - Sheffield, United Kingdom
- Southampton General Hospital ( Site 1502) - Southampton, United Kingdom
- Instituto Dante Pazzanese de Cardiology ( Site 0206) - São Paulo, Brazil
- Incor - Instituto do Coracao ( Site 0200) - São Paulo, Brazil
- UZ Antwerpen ( Site 0601) - Edegem, Antwerpen, Belgium
- Hospital Universitario Central de Asturias ( Site 1303) - Oviedo, Asturias, Principado de, Spain
- Clinica de la Costa S.A.S. ( Site 0400) - Barranquilla, Atlántico, Colombia
- Universitaetsklinikum Freiburg ( Site 2203) - Freiburg im Breisgau, Baden-Wurttemberg, Germany
- Children's Hospital Capital Institute of Pediatrics ( Site 1908) - Beijing, Beijing Municipality, China
- Beijing Anzhen Hospital. Capital Medical University ( Site 1917) - Beijing, Beijing Municipality, China
- Detska nemocnice FN Brno ( Site 0701) - Brno, Brno-mesto, Czechia
- New Zealand Clinical Research (Christchurch) ( Site 1700) - Christchurch, Canterbury, New Zealand
- Universidade Federal Do Ceara ( Site 0201) - Fortaleza, Ceará, Brazil
- National University Hospital-Paediatrics ( Site 1800) - Singapore, Central Singapore, Singapore
- Oncomédica S.A.S ( Site 0401) - Montería, Departamento de Córdoba, Colombia
- Guangdong Provincial People's Hospital ( Site 1915) - Guangzhou, Guangdong, China
- Hospital Clinico Universitario de Santiago de Compostela ( Site 1300) - Santiago de Compostela, La Coruna, Spain
- COMPLEJO HOSPITALARIO DE NAVARRA ( Site 1302) - Pamplona, Navarre, Spain
- Amsterdam UMC, locatie AMC ( Site 1000) - Amsterdam, North Holland, Netherlands
- Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" ( Site 0501) - Monterrey, Nuevo León, Mexico
- Centro de Investigacion Clinica de Oaxaca ( Site 0505) - Oaxaca City, Oaxaca, Mexico
- Explora Salud ( Site 0304) - Santiago, Region M. de Santiago, Chile
- Pontificia Universidad Catolica de Chile ( Site 0300) - Santiago, Region M. de Santiago, Chile
- Hopital Femme Mere Enfant ( Site 2101) - Bron, Rhone, France
- Fundación Cardiovascular de Colombia ( Site 0402) - Piedecuesta, Santander Department, Colombia
- Children's Hospital of Fudan University ( Site 1906) - Shanghai, Shanghai Municipality, China
- Shanghai Children's Medical Center ( Site 1918) - Shanghai, Shanghai Municipality, China
- New Childrens Hospital ( Site 0800) - Helsinki, Uusimaa, Finland
- Fundacion Valle del Lili ( Site 0403) - Cali, Valle del Cauca Department, Colombia
- Monash Children s Hospital ( Site 1603) - Clayton, Victoria, Australia
- Perth Children s Hospital ( Site 1601) - Nedlands, Western Australia, Australia
- The Children's Hospital of Zhejiang University School of Medicine ( Site 1905) - Hangzhou, Zhejiang, China
- Instytut Centrum Zdrowia Matki Polki ( Site 1201) - Lodz, Łódź Voivodeship, Poland