A Phase 2 Clinical Study in Children With HeFH Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing (CLEAR Path 1)

Esperion Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Hypercholesterolemia

Treatments: Drug: Bempedoic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT05694260

1002-041

Details and patient eligibility

About

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

Full description

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

Enrollment: 54 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Patients at 16 to \<30 kg body weight at screening receiving once daily 60 mg bempedoic acid for 8 weeks followed by 90 mg bempedoic acid for 8 weeks.

Treatment:

Drug: Bempedoic acid

Cohort 2

Experimental group

Description:

Patients at 30 to 60 kg body weight at screening receiving once daily120 mg bempedoic acid for 8 weeks followed by 150 mg bempedoic acid for 8 weeks.

Treatment:

Drug: Bempedoic acid

Cohort 3

Experimental group

Description:

Patients at greater than 60 kg body weight at screening receiving once daily 180 mg bempedoic acid for 8 weeks.

Treatment:

Drug: Bempedoic acid