An Open Label Study of Bempedoic Acid in Patients Aged 6 to 17 Years and Diagnosed with HeFH
Research type
Research Study
Full title
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
IRAS ID
1006008
Contact name
Satish Nachaegari
Contact email
Sponsor organisation
Esperion Therapeutics, Inc.
Eudract number
2018-004084-31
Research summary
Bempedoic acid is a medicine developed by Esperion Therapeutics, Inc. that lowers levels of ‘bad’ cholesterol (also called “LDL-cholesterol”) in the blood. Bempedoic acid is a prescription medicine approved in the United States (US) along with diet and other lipid-lowering drugs for the treatment of adults with known heart disease and/or HeFH who need additional lowering of “bad“ cholesterol. Bempedoic acid is approved in the United Kingdom along with diet, alone or with other lipid-lowering drugs for the treatment of adults with primary hypercholesterolemia or mixed dyslipidemia who need additional lowering of “bad” cholesterol. Primary hypercholesterolemia, HeFH or mixed dyslipidemia are conditions that are associated with a high cholesterol level in the blood. Bempedoic acid is considered under “investigational use” for treatment of other conditions. “Investigational use” means that this drug has not been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) or other regulatory/health authorities around the world for the condition being studied. Throughout this information sheet, bempedoic acid will be referred to as the “study drug”.\nThe purpose of this clinical research study is to evaluate how well bempedoic acid works on lowering high LDL-C, how much of bempedoic acid is in your child’s blood, and how well it is tolerated in children and adolescents with high cholesterol
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
22/WM/0228
Date of REC Opinion
23 Jan 2023
REC opinion
Further Information Unfavourable Opinion