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Bored Studies
RecruitingPhase 2/Phase 3

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

Merck Sharp & Dohme LLC · NCT07058077

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 6–17 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2, Phase 3
Target enrollment
153
US sites recruiting
8
Study start
August 21, 2025
Record last updated
October 7, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Enlicitide Decanoate; Placebo

Conditions: Heterozygous Familial Hypercholesterolemia (HeFH)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

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

    Wilmington, DE 19803

    Site contact: Study Coordinator · 302-651-6600

  • Children's National Medical Center ( Site 0015)

    Washington D.C., DC 20010

    Site contact: Study Coordinator · 202-476-5000

  • Excel Medical Clinical Trials ( Site 0008)

    Boca Raton, FL 33434

    Site contact: Study Coordinator · 561-529-4356

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

    Atlanta, GA 30329

    Site contact: Study Coordinator · 404-256-2593

  • Boston Children's Hospital ( Site 0018)

    Boston, MA 02115

    Site contact: Study Coordinator · 616-354-3372

  • St. Louis Children's Hospital ( Site 0014)

    St Louis, MO 63110

    Site contact: Study Coordinator · 314-454-6000

  • Cincinnati Children's Hospital Medical Center ( Site 0016)

    Cincinnati, OH 45229

    Site contact: Study Coordinator · 513-636-3200

  • West Virginia University ( Site 0013)

    Morgantown, WV 26506

    Site contact: Study Coordinator · 304-598-4000

Study contacts (from the official record)

  • Toll Free Number · 1-888-577-8839 · Trialsites@msd.com
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