MedTrace Logo

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

NCT07058077 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Heterozygous Familial Hypercholesterolemia (HeFH)

Interventions

DRUG

Enlicitide Decanoate

Enlicitide decanoate taken by mouth

DRUG

Placebo

Placebo tablet matched to enlicitide decanoate taken by mouth

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-21
Primary Completion
2033-12-04
Completion
2037-01-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Chile
  • China
  • Colombia
  • Finland
  • Netherlands
  • New Zealand
  • Singapore
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07058077 on ClinicalTrials.gov