NCT05694260

A Clinical Study in Children With Heterozygous Familial Hypercholesterolemia (HeFH) Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing (CLEAR Path 1)

An Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Bempedoic Acid in Pediatric Patients (6 to 17 Years of Age) With Heterozygous Familial Hypercholesterolemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Esperion Therapeutics, Inc. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Multiple-dose study to measure pharmacokinetics, pharmacodynamics and safety of bempedoic acid in pediatric participants 6 to 17 years of age with HeFH.

Detailed description

Dose-selection based on body weight will be determined for use in pediatric clinical development.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Bempedoic acid	Once daily oral dosing with oral tablets.

Timeline

• Start date: 2023-01-12
• Primary completion: 2025-06-04
• Completion: 2025-06-04
• First posted: 2023-01-23
• Last updated: 2025-08-08

Locations

24 sites across 6 countries: United States, Canada, Denmark, Germany, Netherlands, Spain

Regulatory

• FDA-regulated drug study