A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
NCT ID: NCT07058077
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
153 participants
INTERVENTIONAL
2025-08-21
2037-01-24
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part A: Enlicitide Decanoate
Participants receive enlicitide decanoate orally once daily (QD) at a dosage determined by age for up to 2 weeks.
Enlicitide Decanoate
Enlicitide decanoate taken by mouth
Part B: Enlicitide Decanoate
Participants receive enlicitide decanoate QD at a dosage determined by age for up to 24 weeks.
Enlicitide Decanoate
Enlicitide decanoate taken by mouth
Part B: Placebo
Participants receive placebo orally QD for up to 24 weeks.
Placebo
Placebo tablet matched to enlicitide decanoate taken by mouth
Open-Label Extension: Enlicitide Decanoate
Participants who complete either Part A or Part B may enroll in this open-label extension arm. Participants in the extension arm receive enlicitide decanoate QD at a dosage determined by age for up to 3 years.
Enlicitide Decanoate
Enlicitide decanoate taken by mouth
Interventions
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Enlicitide Decanoate
Enlicitide decanoate taken by mouth
Placebo
Placebo tablet matched to enlicitide decanoate taken by mouth
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 a nonstatin LLT with documented intolerance to at least 2 different statins or 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
* Has a history of nephrotic syndrome
* Has any clinically significant malabsorption condition based on principal 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
6 Years
17 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
The Children's Hospital of Zhejiang University School of Medicine ( Site 1905)
Hangzhou, Zhejiang, China
New Zealand Clinical Research (Christchurch) ( Site 1700)
Christchurch, Canterbury, New Zealand
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Related Links
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Merck Clinical Trials Information
Other Identifiers
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U1111-1314-5796
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024-519068-42-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
0616-029
Identifier Type: -
Identifier Source: org_study_id
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