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

Part of paid clinical trials in Wilmington, Delaware.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07058077
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Heterozygous Familial Hypercholesterolemia (HeFH)

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Enlicitide Decanoate — DRUG
    Enlicitide decanoate taken by mouth
  • Placebo — DRUG
    Placebo tablet matched to enlicitide decanoate taken by mouth

Study Details

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.

Key Dates

Start date
Aug 21, 2025
Status verified
May 2026
Primary completion
Dec 4, 2033
Completion
Jan 23, 2037

Study Design

Enrollment
153 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Enlicitide Decanoate
    Participants receive enlicitide decanoate orally once daily (QD) at a dosage determined by age for up to 2 weeks.
  • Experimental: Part B: Enlicitide Decanoate
    Participants receive enlicitide decanoate QD at a dosage determined by age for up to 24 weeks.
  • Placebo Comparator: Part B: Placebo
    Participants receive placebo orally QD for up to 24 weeks.
  • Experimental: 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.

Primary Outcome Measure

Part A: Maximum Plasma Concentration (Cmax) of Enlicitide [ Time Frame: At designated timepoints (up to 24 hours postdose on day 14) ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Nemours/Alfred I. duPont Hospital for Children ( Site 0001)WilmingtonDelaware19803
Study Coordinator
302-651-6600
Children's National Medical Center ( Site 0015)Washington D.C.District of Columbia20010
Study Coordinator
202-476-5000
Excel Medical Clinical Trials ( Site 0008)Boca RatonFlorida33434
Study Coordinator
561-529-4356
Children's Healthcare of Atlanta Cardiology ( Site 0026)AtlantaGeorgia30329
Study Coordinator
404-256-2593
Cincinnati Children's Hospital Medical Center ( Site 0016)CincinnatiOhio45229
Study Coordinator
513-636-3200
West Virginia University ( Site 0013)MorgantownWest Virginia26506
Study Coordinator
304-598-4000

Find similar trials in Wilmington, DE

By research site
Nemours/Alfred I. duPont Hospital for Children· Wilmington, DEChildren's National Medical Center· Washington D.C., DCExcel Medical Clinical Trials· Boca Raton, FLChildren's Healthcare of Atlanta Cardiology· Atlanta, GACincinnati Children's Hospital Medical Center· Cincinnati, OHWest Virginia University· Morgantown, WV

Related Studies