A Phase 2 Clinical Study in Children With HeFH Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing
HypercholesterolemiaMultiple-dose study to measure PK, PD and safety of bempedoic acid in pediatric patients 6 to 17 years of age with HeFH.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
6 to 17
Participation 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
Study Location
McMaster University Medical Center
McMaster University Medical CenterHamilton, Ontario
Canada
Contact Study Team
University of Alberta Hospital - Stollery Children's Hospital
University of Alberta Hospital - Stollery Children's HospitalEdmonton, Alberta
Canada
Contact Study Team
The Hospital for Sick Children (SickKids)
The Hospital for Sick Children (SickKids)Toronto, Ontario
Canada
Contact Study Team
Ecogene-21
Ecogene-21Chicoutimi, Quebec
Canada
Contact Study Team
- Study Sponsored By
- Esperion Therapeutics, Inc.
- Participants Required
- More Information
- Study ID:
NCT05694260