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 USA tracker

Sponsor

Merck Sharp & Dohme LLC

Phase

Phase 2/Phase 3

Started

2025-08-21

Last updated

2026-09-14

Condition(s) studied

Heterozygous Familial Hypercholesterolemia (HeFH)

Investigational drug(s) / intervention(s)

Enlicitide DecanoatePlacebo

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

Sex

ALL

Min age

6 Years

Max age

17 Years

Healthy volunteers

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 (43)

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
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
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
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
Instytut Centrum Zdrowia Matki Polki ( Site 1201)	Lodz	Łódź Voivodeship	Recruiting
National University Hospital-Paediatrics ( Site 1800)	Singapore	Central Singapore	Recruiting
Hospital Universitario Central de Asturias ( Site 1303)	Oviedo	Asturias, Principado de	Recruiting
Hospital Clinico Universitario de Santiago de Compostela ( Site 1300)	Santiago de Compostela	La Coruna	Recruiting
COMPLEJO HOSPITALARIO DE NAVARRA ( Site 1302)	Pamplona	Navarre	Recruiting

+ 3 more sites — see the full list on the official registry below.

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 the USA