Clinical Trials in Belgium / NCT07058077
Recruiting
Phase 2/3
A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
NCT07058077 · tracked via the Priya Life Science Belgium tracker
Condition(s) studied
Heterozygous Familial Hypercholesterolemia (HeFH)
Investigational drug(s) / intervention(s)
Enlicitide Decanoate →Placebo
Enlicitide Decanoate: Enlicitide decanoate taken by mouth
Placebo: Placebo tablet matched to enlicitide decanoate taken by mouth
Study summary
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.
Eligibility
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
Primary outcome measure(s)
- Part A: Maximum Plasma Concentration (Cmax) of Enlicitide — At designated timepoints (up to 24 hours postdose on day 14)
Blood samples will be collected to determine the Cmax of enlicitide. - Part A: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide — At designated timepoints (up to 24 hours postdose on day 14)
Blood samples will be collected to determine the AUC0-24 of enlicitide. - Part B: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) — Baseline and Week 24
Blood samples will be collected to determine the percent change from baseline in LDL-C. - Number of Participants Who Experience an Adverse Event (AE) — Up to approximately 188 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. - Number of Participants Who Discontinue Study Treatment Due to an AE — Up to approximately 180 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Trial sites (47)
| Facility | City | Region | Status |
|---|---|---|---|
| Nemours/Alfred I. duPont Hospital for Children ( Site 0001) | Wilmington | Delaware | Recruiting |
| Children's National Medical Center ( Site 0015) | Washington D.C. | District of Columbia | Recruiting |
| Excel Medical Clinical Trials ( Site 0008) | Boca Raton | Florida | Recruiting |
| Children's Healthcare of Atlanta Cardiology ( Site 0026) | Atlanta | Georgia | Recruiting |
| Boston Children's Hospital ( Site 0018) | Boston | Massachusetts | Recruiting |
| St. Louis Children's Hospital ( Site 0014) | St Louis | Missouri | Recruiting |
| Cincinnati Children's Hospital Medical Center ( Site 0016) | Cincinnati | Ohio | Recruiting |
| West Virginia University ( Site 0013) | Morgantown | West Virginia | Recruiting |
| Monash Children s Hospital ( Site 1603) | Clayton | Victoria | Recruiting |
| Perth Children s Hospital ( Site 1601) | Nedlands | Western Australia | Recruiting |
| UZ Antwerpen ( Site 0601) | Edegem | Antwerpen | Recruiting |
| Universidade Federal Do Ceara ( Site 0201) | Fortaleza | Ceará | Recruiting |
| Instituto Dante Pazzanese de Cardiology ( Site 0206) | São Paulo | Brazil | Recruiting |
| Incor - Instituto do Coracao ( Site 0200) | São Paulo | Brazil | Recruiting |
| Biocenter ( Site 0305) | Concepción | Biobio | Recruiting |
| Explora Salud ( Site 0304) | Santiago | Region M. de Santiago | Recruiting |
| Pontificia Universidad Catolica de Chile ( Site 0300) | Santiago | Region M. de Santiago | Recruiting |
| Children's Hospital Capital Institute of Pediatrics ( Site 1908) | Beijing | Beijing Municipality | Recruiting |
| Beijing Anzhen Hospital. Capital Medical University ( Site 1917) | Beijing | Beijing Municipality | Recruiting |
| Guangdong Provincial People's Hospital ( Site 1915) | Guangzhou | Guangdong | Recruiting |
| Children's Hospital of Fudan University ( Site 1906) | Shanghai | Shanghai Municipality | Recruiting |
| Shanghai Children's Medical Center ( Site 1918) | Shanghai | Shanghai Municipality | Recruiting |
| The Children's Hospital of Zhejiang University School of Medicine ( Site 1905) | Hangzhou | Zhejiang | Recruiting |
| Clinica de la Costa S.A.S. ( Site 0400) | Barranquilla | Atlántico | Recruiting |
| Oncomédica S.A.S ( Site 0401) | Montería | Departamento de Córdoba | Recruiting |
| Fundación Cardiovascular de Colombia ( Site 0402) | Piedecuesta | Santander Department | Recruiting |
| Fundacion Valle del Lili ( Site 0403) | Cali | Valle del Cauca Department | Recruiting |
| Detska nemocnice FN Brno ( Site 0701) | Brno | Brno-mesto | Recruiting |
| Vseobecna fakultni nemocnice v Praze ( Site 0702) | Prague | Praha 2 | Recruiting |
| Fakultni nemocnice v Motole ( Site 0700) | Prague | Czechia | Recruiting |
| New Childrens Hospital ( Site 0800) | Helsinki | Uusimaa | Recruiting |
| Hopital Femme Mere Enfant ( Site 2101) | Bron | Rhone | Recruiting |
| Universitaetsklinikum Freiburg ( Site 2203) | Freiburg im Breisgau | Baden-Wurttemberg | Recruiting |
| Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" ( Site 0501) | Monterrey | Nuevo León | Recruiting |
| Centro de Investigacion Clinica de Oaxaca ( Site 0505) | Oaxaca City | Oaxaca | Recruiting |
| INVECORDIS S.C. ( Site 0503) | Huixquilucan | Mexico | Recruiting |
| Amsterdam UMC, locatie AMC ( Site 1000) | Amsterdam | North Holland | Recruiting |
| New Zealand Clinical Research (Christchurch) ( Site 1700) | Christchurch | Canterbury | Recruiting |
| Oslo Universitetssykehus Aker-Lipidklinikken ( Site 1100) | Oslo | Norway | Recruiting |
| Instytut Centrum Zdrowia Matki Polki ( Site 1201) | Lodz | Łódź Voivodeship | Recruiting |
+ 7 more sites — see the full list on the official registry below.
More Merck Sharp & Dohme LLC trials in Belgium
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07058077 on ClinicalTrials.gov ↗ ← All trials in Belgium