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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 2 / Phase 3

Age range

6 years - 17 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

153 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Quadruple masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (48)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

48 locations

Study team and timeline

Lead sponsor

Merck Sharp & Dohme LLC

Study start

Aug 21, 2025 Actual

Primary completion

Dec 4, 2033 Estimated

Study completion

Jan 23, 2037 Estimated

First posted

Jul 10, 2025 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts