Overview

A Phase 2 Clinical Study in Children With HeFH Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing

Status:
Recruiting

Trial end date:
2024-05-24

Target enrollment:
0

Participant gender:
All

Summary

Multiple-dose study to measure PK, PD and safety of bempedoic acid in pediatric patients 6 to 17 years of age with HeFH.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Esperion Therapeutics, Inc.

Treatments:

8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid

Criteria

Inclusion Criteria:

Written informed consent and assent (where applicable) Aged 6-17 years old Diagnosis of
HeFH (heterozygous familial hypercholesterolemia) Treatment with approved stable lipid
modifying therapies Fasting LDL-C greater than or equal to 130 mg/dL (3.4 mmol/L)

Exclusion Criteria:

Diagnosis of HoFH (homozygous familial hypercholesterolemia) or compound HeFH Fasting
Triglyceride greater than or equal to 400 mg/dL (4.5 mmol/L) Type 1 or Type 2 diabetes or
newly diagnosed impaired glucose tolerance Women/girls who are pregnant or breastfeeding