Effect of CER-001 on Plaque Volume in Homozygous Familial Hypercholesterolemia (HoFH) Subjects
Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
Summary
The available medications used to treat HoFH are targeted at reducing circulating levels of
total and LDL-cholesterol. These measures can retard the progression of cardiovascular
disease, however, they are unlikely to regress existing disease due to years of cholesterol
accumulation in the vessel walls and therefore cannot adequately reduce the existing risk for
an ischemic event. HDL has multiple actions that could lead to plaque stabilization and
regression, such as rapid removal of large quantities of cholesterol from the vasculature,
improvement in endothelial function, protection against oxidative damage and reduction in
inflammation. 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 measurements in patients with HoFH.