Bempedoic Acid in Pediatric Patients With Heterozygous Familial Hypercholesterolemia

What is the Purpose of this Study?

The purpose of this study is to evaluate the investigational use of a drug called bempedoic acid in individuals who have heterozygous familial hypercholesterolemia (HeFH). HeFH is a condition in which there are higher-than-normal amounts of low-density lipoprotein cholesterol (LDL-C) in the blood that is not sufficiently under control with current cholesterol-lowering medication(s). Researchers aim to determine how well bempedoic acid works to lower high LDL-C, how much of the drug is in participants’ blood, and how well it is tolerated in children and adolescents with high cholesterol.


Eligibility

  • * Participant's parent(s)/guardian(s) must be willing to provide written informed consent and the participant must provide informed assent before any study-specific procedures are performed;
  • * Participant must be aged 6-17 years old and willing to swallow tablets;
  • * Participant must weigh at least 16 kilograms (kg);
  • * Participant must have a diagnosis of HeFH prior to receiving the first dose of study medication at Treatment Visit T1 per Make Early Diagnosis to Prevent Early Deaths project (MEDPED) criteria by meeting at least one of the following clinical criteria:
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

An Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Bempedoic Acid in Pediatric Patients with Heterozygous Familial Hypercholesterolemia

Study Details
Disease Type/Condition

Congenital heart, Familial hypercholesterolemia

Principal Investigator

Almeida-Jones, Myriam

Age Group

Children

Phase

II

IRB Number

STUDY00002393

ClinicalTrials.gov ID

NCT05694260

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Congenital heart, Familial hypercholesterolemia

Principal Investigator

Almeida-Jones, Myriam

Age Group

Children

Phase

II

IRB Number

1002-041

ClinicalTrials.gov ID

NCT05694260

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org