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: 2025-11-12
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2/PHASE3
153 participants
INTERVENTIONAL
2025-08-21
2037-01-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Enlicitide Decanoate
Enlicitide decanoate taken by mouth
Placebo
Placebo tablet matched to enlicitide decanoate taken by mouth
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
New Zealand Clinical Research (Christchurch) ( Site 1700)
Christchurch, Canterbury, New Zealand
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Merck Clinical Trials Information
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
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