Despite the availability of several classes of very effective drugs available to treat
heterozygous Familial Hypercholesterolemia (HeFH), there remains a large unmet medical need
for new, effective and well tolerated therapies. There are a number of therapies given on a
chronic basis to reduce long term risk, such as statins, fibrates, niacin, omega 3 fatty
acids, resins, cholesterol absorption inhibitors and antiplatelet or anticoagulant drugs, but
subjects with heterozygous Familial Hypercholesterolemia remain at high risk for
cardiovascular events. There is still a need for acute therapies that can lead to rapid
pacification of unstable plaque in order to reduce the risk of these events. This study will
assess the effects of CER-001 , a recombinant human Apo-A-1 based HDL mimetic, on indices of
atherosclerotic plaque progression and regression as assessed by 3Tesla MRI (3TMRI)and
intravascular ultrasound (IVUS) evaluations in patients with HeFH.