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NCT05694260
A Phase 2 Clinical Study in Children With HeFH Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing
Conditions: Hypercholesterolemia
Sex: All
Ages: 6 Years – 17 Years
Phase: PHASE2
Enrollment: 54
Sponsor: Esperion Therapeutics, Inc.
Location: United States
Summary
Multiple-dose study to measure PK, PD and safety of bempedoic acid in pediatric patients 6 to 17 years of age with HeFH.
Eligibility 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
Source: ClinicalTrials.gov (NCT05694260). StuddyBuddy aggregates publicly available trial information.