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NCT07058077PHASE2, PHASE3Recruiting

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

Merck Sharp & Dohme LLC

Start Date

8/21/2025

Completion Date

1/23/2037

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 Criteria

Age Range: 6 years to 17 years

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

Interventions

DRUG

Enlicitide Decanoate

DRUG

Placebo

Interested in This Trial?

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Conditions

Heterozygous Familial Hypercholesterolemia (HeFH)

Locations

Nemours/Alfred I. duPont Hospital for Children ( Site 0001)

Wilmington, Delaware 19803

United States

Children's National Medical Center ( Site 0015)

Washington D.C., District of Columbia 20010

United States

Excel Medical Clinical Trials ( Site 0008)

Boca Raton, Florida 33434

United States

Children's Healthcare of Atlanta Cardiology ( Site 0026)

Atlanta, Georgia 30329

United States

Boston Children's Hospital ( Site 0018)

Boston, Massachusetts 02115

United States

Cincinnati Children's Hospital Medical Center ( Site 0016)

Cincinnati, Ohio 45229

United States

West Virginia University ( Site 0013)

Morgantown, West Virginia 26506

United States

Monash Children s Hospital ( Site 1603)

Clayton, Victoria 3168

Australia

UZ Antwerpen ( Site 0601)

Edegem, Antwerpen 2650

Belgium

Universidade Federal Do Ceara ( Site 0201)

Fortaleza, Ceará 60430270

Brazil

Instituto Dante Pazzanese de Cardiology ( Site 0206)

São Paulo, 04012-909

Brazil

Incor - Instituto do Coracao ( Site 0200)

São Paulo, 05403900

Brazil

Explora Salud ( Site 0304)

Santiago, Region M. de Santiago 7500504

Chile

Pontificia Universidad Catolica de Chile ( Site 0300)

Santiago, Region M. de Santiago 8330032

Chile

Beijing Anzhen Hospital. Capital Medical University ( Site 1917)

Beijing, Beijing Municipality 100029

China

Guangdong Provincial People's Hospital ( Site 1915)

Guangzhou, Guangdong 510080

China

Children's Hospital of Fudan University ( Site 1906)

Shanghai, Shanghai Municipality 200032

China

Shanghai Children's Medical Center ( Site 1918)

Shanghai, Shanghai Municipality 200120

China

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

Hangzhou, Zhejiang 310057

China

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

Barranquilla, Atlántico 080020

Colombia

Oncomédica S.A.S ( Site 0401)

Montería, Departamento de Córdoba 230002

Colombia

Fundación Cardiovascular de Colombia ( Site 0402)

Piedecuesta, Santander Department 681017

Colombia

Fundacion Valle del Lili ( Site 0403)

Cali, Valle del Cauca Department 760032

Colombia

Fakultni nemocnice v Motole ( Site 0700)

Prague, 150 00

Czechia

New Childrens Hospital ( Site 0800)

Helsinki, Uusimaa 00029

Finland

Universitaetsklinikum Freiburg ( Site 2203)

Freiburg im Breisgau, Baden-Wurttemberg 79106

Germany

Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" ( Site 0501)

Monterrey, Nuevo León 64460

Mexico

Centro de Investigacion Clinica de Oaxaca ( Site 0505)

Oaxaca City, Oaxaca 68020

Mexico

INVECORDIS S.C. ( Site 0503)

Huixquilucan, 52763

Mexico

Amsterdam UMC, locatie AMC ( Site 1000)

Amsterdam, North Holland 1105 AZ

Netherlands

New Zealand Clinical Research (Christchurch) ( Site 1700)

Christchurch, Canterbury 8011

New Zealand

National University Hospital-Paediatrics ( Site 1800)

Singapore, Central Singapore 117599

Singapore

Hospital Universitario Central de Asturias ( Site 1303)

Oviedo, Asturias, Principado de 33011

Spain

Hospital Clinico Universitario de Santiago de Compostela ( Site 1300)

Santiago de Compostela, La Coruna 15706

Spain

COMPLEJO HOSPITALARIO DE NAVARRA ( Site 1302)

Pamplona, Navarre 31009

Spain

Birmingham Childrens Hospital ( Site 1501)

Birmingham, B4 6NH

United Kingdom

Sheffield Childrens Hospital ( Site 1503)

Sheffield, S10 2TH

United Kingdom

Southampton General Hospital ( Site 1502)

Southampton, SO16 6YD

United Kingdom