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Enlicitide Decanoate for Children with High Cholesterol (HeFH)

This study is testing a new oral medication called enlicitide decanoate for children and adolescents (ages 6-17) who have Heterozygous Familial Hypercholesterolemia (HeFH). HeFH is a genetic condition that causes very high levels of "bad" cholesterol (LDL-C). The study aims to find out if enlicitide decanoate is safe, how well children tolerate it, how the body processes the medication, and if it can effectively lower LDL-C levels compared to a placebo (a pill with no active medicine). To join, participants must have a confirmed or suspected diagnosis of HeFH and high LDL-C, even while on other cholesterol-lowering treatments. The study plans to enroll 153 participants.

Study design
This is an interventional study comparing enlicitide decanoate to a placebo. It plans to enroll 153 participants aged 6 to 17 years.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Cholesterol levels will be measured at baseline and again at Week 24. Drug levels in the blood will be measured up to 24 hours after a dose on day 14.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07058077

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

Recruiting
PHASE2Ages 6–17InterventionalTreatment
Merck Sharp & Dohme LLC
~153 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:Enlicitide DecanoatePlacebo

At a glance

Recruiting sites
43 of 43 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Maximum Plasma Concentration (Cmax) of Enlicitide
Measured over At designated timepoints (up to 24 hours postdose on day 14)
+4 more outcomes measured

Conditions

Heterozygous Familial Hypercholesterolemia (HeFH)

Explore related trials

Familial hypercholesterolemia - heterozygous

NCT07058077

Where you'd take part

This study runs at 43 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Amsterdam UMC, locatie AMC ( Site 1000)

    Amsterdam, North Holland, Netherlandsstudy coordinator listed

    Recruiting

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

    Beijing, Beijing Municipality, Chinastudy coordinator listed

    Recruiting

  • Birmingham Childrens Hospital ( Site 1501)

    Birmingham, United Kingdomstudy coordinator listed

    Recruiting

  • Boston Children's Hospital ( Site 0018)

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Centro de Investigacion Clinica de Oaxaca ( Site 0505)

    Oaxaca City, Oaxaca, Mexicostudy coordinator listed

    Recruiting

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

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • Children's Hospital Capital Institute of Pediatrics ( Site 1908)

    Beijing, Beijing Municipality, Chinastudy coordinator listed

    Recruiting

  • Children's Hospital of Fudan University ( Site 1906)

    Shanghai, Shanghai Municipality, Chinastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Part A: Maximum Plasma Concentration (Cmax) of EnlicitideAt designated timepoints (up to 24 hours postdose on day 14)

    Blood samples will be collected to determine the Cmax of enlicitide.

  • Part A: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of EnlicitideAt designated timepoints (up to 24 hours postdose on day 14)

    Blood samples will be collected to determine the AUC0-24 of enlicitide.

  • Part B: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)Baseline and Week 24

    Blood samples will be collected to determine the percent change from baseline in LDL-C.

  • Number of Participants Who Experience an Adverse Event (AE)Up to approximately 188 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  • Number of Participants Who Discontinue Study Treatment Due to an AEUp to approximately 180 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.