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

Last updated: March 4, 2026
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2/3

Condition

Hypercholesterolemia

Familial Hypercholesterolemia

Treatment

Enlicitide Decanoate

Placebo

Clinical Study ID

NCT07058077
0616-029
U1111-1314-5796
2024-519068-42-00
  • Ages 6-17
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

Inclusion criteria include, but are not limited to:

  • Has possible or definite diagnosis of HeFH based on a locally accepted diagnosticalgorithm 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); or anonstatin LLT with documented intolerance to at least 2 different statins or refusalof 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

Exclusion Criteria:

Exclusion criteria include, but are not limited to:

  • Has a history of homozygous FH based on genetic or clinical criteria, or history ofknown compound heterozygous FH, or double heterozygous FH

  • Has a history of nephrotic syndrome

  • Has any clinically significant malabsorption condition based on principalinvestigator assessment

  • Was previously treated/is being treated with certain other cholesterol loweringmedications, including proprotein convertase subtilisin/kexin type 9 (PCSK9)inhibitors without adequate washout

Study Design

Total Participants: 153
Treatment Group(s): 2
Primary Treatment: Enlicitide Decanoate
Phase: 2/3
Study Start date:
August 21, 2025
Estimated Completion Date:
January 23, 2037

Connect with a study center

  • Monash Children s Hospital ( Site 1603)

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Monash Children s Hospital ( Site 1603)

    Clayton 2171400, Victoria 2145234 3168
    Australia

    Site Not Available

  • UZ Antwerpen ( Site 0601)

    Edegem, Antwerpen 2650
    Belgium

    Active - Recruiting

  • Universidade Federal Do Ceara ( Site 0201)

    Fortaleza, Ceará 60430270
    Brazil

    Active - Recruiting

  • Universidade Federal Do Ceara ( Site 0201)

    Fortaleza 3399415, Ceará 3402362 60430270
    Brazil

    Site Not Available

  • Incor - Instituto do Coracao ( Site 0200)

    São Paulo, 05403900
    Brazil

    Active - Recruiting

  • Incor - Instituto do Coracao ( Site 0200)

    São Paulo 3448439, 05403900
    Brazil

    Site Not Available

  • Beijing Anzhen Hospital. Capital Medical University ( Site 1917)

    Beijing, Beijing Municipality 100029
    China

    Active - Recruiting

  • Beijing Anzhen Hospital. Capital Medical University ( Site 1917)

    Beijing 1816670, Beijing Municipality 2038349 100029
    China

    Site Not Available

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

    Hangzhou, Zhejiang 310057
    China

    Active - Recruiting

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

    Hangzhou 1808926, Zhejiang 1784764 310057
    China

    Site Not Available

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

    Barranquilla, Atlántico 080020
    Colombia

    Active - Recruiting

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

    Barranquilla 3689147, Atlántico 3689436 080020
    Colombia

    Site Not Available

  • Oncomédica S.A.S ( Site 0401)

    Montería, Departamento de Córdoba 230002
    Colombia

    Active - Recruiting

  • Oncomédica S.A.S ( Site 0401)

    Montería 3674453, Departamento de Córdoba 3685889 230002
    Colombia

    Site Not Available

  • Fundación Cardiovascular de Colombia ( Site 0402)

    Piedecuesta, Santander Department 681017
    Colombia

    Active - Recruiting

  • Fundación Cardiovascular de Colombia ( Site 0402)

    Piedecuesta 3672328, Santander Department 3668578 681017
    Colombia

    Site Not Available

  • Fundacion Valle del Lili ( Site 0403)

    Cali, Valle del Cauca Department 760032
    Colombia

    Active - Recruiting

  • Fundacion Valle del Lili ( Site 0403)

    Cali 3687925, Valle del Cauca Department 3666313 760032
    Colombia

    Site Not Available

  • New Childrens Hospital ( Site 0800)

    Helsinki, Uusimaa 00029
    Finland

    Active - Recruiting

  • New Childrens Hospital ( Site 0800)

    Helsinki 658225, Uusimaa 830709 00029
    Finland

    Site Not Available

  • Amsterdam UMC, locatie AMC ( Site 1000)

    Amsterdam, North Holland 1105 AZ
    Netherlands

    Active - Recruiting

  • Amsterdam UMC, locatie AMC ( Site 1000)

    Amsterdam 2759794, North Holland 2749879 1105 AZ
    Netherlands

    Site Not Available

  • New Zealand Clinical Research (Christchurch) ( Site 1700)

    Christchurch, Canterbury 8011
    New Zealand

    Active - Recruiting

  • New Zealand Clinical Research (Christchurch) ( Site 1700)

    Christchurch 2192362, Canterbury 2192628 8011
    New Zealand

    Site Not Available

  • National University Hospital-Paediatrics ( Site 1800)

    Singapore, Central Singapore 117599
    Singapore

    Active - Recruiting

  • COMPLEJO HOSPITALARIO DE NAVARRA ( Site 1302)

    Pamplona, Navarre 31009
    Spain

    Active - Recruiting

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

    Wilmington, Delaware 19803
    United States

    Active - Recruiting

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

    Wilmington 4145381, Delaware 4142224 19803
    United States

    Site Not Available

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

    Wilmington 4145381, Delaware 4142224 19803
    United States

    Active - Recruiting

  • Children's National Medical Center ( Site 0015)

    Washington D.C., District of Columbia 20010
    United States

    Active - Recruiting

  • Children's National Medical Center ( Site 0015)

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Site Not Available

  • Excel Medical Clinical Trials ( Site 0008)

    Boca Raton, Florida 33434
    United States

    Active - Recruiting

  • Excel Medical Clinical Trials ( Site 0008)

    Boca Raton 4148411, Florida 4155751 33434
    United States

    Site Not Available

  • Excel Medical Clinical Trials (0008)

    Boca Raton 4148411, Florida 4155751 33434
    United States

    Active - Recruiting

  • Children's Healthcare of Atlanta Cardiology ( Site 0026)

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

  • Children's Healthcare of Atlanta Cardiology ( Site 0026)

    Atlanta 4180439, Georgia 4197000 30329
    United States

    Site Not Available

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