Study of Anaceptrapib in Heterozygous Familial Hypercholesterolemia
Research type
Research Study
Full title
A 1-Year, Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Assess the Efficacy and Tolerability of Anacetrapib When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Medication(s) in Patients with Heterozygous Familial Hypercholesterolemia
IRAS ID
94683
Contact name
Handrean Soran
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2011-004525-27
Duration of Study in the UK
6 years, 8 months, 4 days
Research summary
Heterozygous familial hypercholesterolemia (HeFH) is a genetic disorder caused by mutations in the LDL receptor (which normally removes LDL from the circulation) or apolipoprotein B genes (which is the part of LDL that binds with the receptor) leading to significantly increased levels of LDL-C (low-density lipoprotein cholesterol or ‘bad cholesterol’). An estimated 1 in 500 people in the general population have HeFH and the disorder increases the risk of heart attack and stroke. Established lipid-lowering therapies alone do not currently reduce the LDL-C levels sufficiently in this patient group.
Anacetrapib is being developed to reduce the risk of heart attack and stroke. The drug lowers the activity of a protein, cholesteryl ester transfer protein (CETP), in blood to decrease the amount of LDL-C (bad cholesterol) and increase the amount of HDL-C (good cholesterol). These changes are usually associated with a lower risk of heart attack and stroke.
The purpose of this study is to test the safety of the research study drug, anacetrapib and test how effective anacetrapib is at lowering bad cholesterol (LDL-C) when compared to placebo (a look-alike tablet with no active ingredients, sometimes called a sugar pill). The study drug will be taken in addition to the patient’s ongoing therapy.
Approximately 300 people with HeFH aged 18-80 will take part in this study worldwide and will receive treatment for about 1 year. Participants will be assigned by chance to get either anacetrapib 100mg or placebo. (There is a 1 in 3 chance of getting placebo only). Participants will need to visit the study doctor about 8 times, plus a final visit 12 weeks after their last dose of study medication. Procedures performed will include physical examinations, blood tests and ECGs (electrocardiogram to measure the electrical activity of the heart).REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
12/NW/0044
Date of REC Opinion
26 Mar 2012
REC opinion
Further Information Favourable Opinion