RecruitingPhase 2Phase 3NCT07058077

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants With Heterozygous Familial Hypercholesterolemia

Sponsor

Merck Sharp & Dohme LLC

Enrollment

153 participants

Start Date

Aug 21, 2025

Study Type

INTERVENTIONAL

Conditions

Heterozygous Familial Hypercholesterolemia (HeFH)

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

Min Age: 6 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Enlicitide Decanoate and a drug called Placebo for people with heterozygous familial hypercholesterolemia (hefh). The study is currently recruiting participants at 38 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEnlicitide Decanoate

Enlicitide decanoate taken by mouth

DRUGPlacebo

Placebo tablet matched to enlicitide decanoate taken by mouth

Locations(43)

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

Monash Children s Hospital ( Site 1603)

Clayton, Victoria, Australia

Perth Children s Hospital ( Site 1601)

Nedlands, Western Australia, Australia

UZ Antwerpen ( Site 0601)

Edegem, Antwerpen, Belgium

Universidade Federal Do Ceara ( Site 0201)

Fortaleza, Ceará, Brazil

Instituto Dante Pazzanese de Cardiology ( Site 0206)

São Paulo, Brazil

Incor - Instituto do Coracao ( Site 0200)

São Paulo, Brazil

Explora Salud ( Site 0304)

Santiago, Region M. de Santiago, Chile

Pontificia Universidad Catolica de Chile ( Site 0300)

Santiago, Region M. de Santiago, Chile

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

Guangdong Provincial People's Hospital ( Site 1915)

Guangzhou, Guangdong, China

Children's Hospital of Fudan University ( Site 1906)

Shanghai, Shanghai Municipality, China

Shanghai Children's Medical Center ( Site 1918)

Shanghai, Shanghai Municipality, China

The Children's Hospital of Zhejiang University School of Medicine ( Site 1905)

Hangzhou, Zhejiang, China

Clinica de la Costa S.A.S. ( Site 0400)

Barranquilla, Atlántico, Colombia

Oncomédica S.A.S ( Site 0401)

Montería, Departamento de Córdoba, Colombia

Fundación Cardiovascular de Colombia ( Site 0402)

Piedecuesta, Santander Department, Colombia

Fundacion Valle del Lili ( Site 0403)

Cali, Valle del Cauca Department, Colombia

Detska nemocnice FN Brno ( Site 0701)

Brno, Brno-mesto, Czechia

Fakultni nemocnice v Motole ( Site 0700)

Prague, Czechia

New Childrens Hospital ( Site 0800)

Helsinki, Uusimaa, Finland

Hopital Femme Mere Enfant ( Site 2101)

Bron, Rhone, France

Universitaetsklinikum Freiburg ( Site 2203)

Freiburg im Breisgau, Baden-Wurttemberg, Germany

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

INVECORDIS S.C. ( Site 0503)

Huixquilucan, Mexico

Amsterdam UMC, locatie AMC ( Site 1000)

Amsterdam, North Holland, Netherlands

New Zealand Clinical Research (Christchurch) ( Site 1700)

Christchurch, Canterbury, New Zealand

Instytut Centrum Zdrowia Matki Polki ( Site 1201)

Lodz, Łódź Voivodeship, Poland

National University Hospital-Paediatrics ( Site 1800)

Singapore, Central Singapore, Singapore

Hospital Universitario Central de Asturias ( Site 1303)

Oviedo, Asturias, Principado de, Spain

Hospital Clinico Universitario de Santiago de Compostela ( Site 1300)

Santiago de Compostela, La Coruna, Spain

COMPLEJO HOSPITALARIO DE NAVARRA ( Site 1302)

Pamplona, Navarre, Spain

Birmingham Childrens Hospital ( Site 1501)

Birmingham, United Kingdom

Sheffield Childrens Hospital ( Site 1503)

Sheffield, United Kingdom

Southampton General Hospital ( Site 1502)

Southampton, United Kingdom

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NCT07058077

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