Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
Status:
Completed
Trial end date:
2020-03-17
Target enrollment:
Participant gender:
Summary
The primary objective of the study is to demonstrate the reduction of low-density lipoprotein
cholesterol (LDL-C) by evinacumab intravenously (IV) in comparison to placebo after 24 weeks
in patients with homozygous familial hypercholesterolemia (HoFH). The secondary objectives of
the study are to evaluate the effect of evinacumab IV on other lipid parameters, evaluate the
effect of evinacumab on LDL-C goal attainment, assess the effect of evinacumab on eligibility
for apheresis (using German and US apheresis criteria), evaluate the safety and tolerability
of evinacumab in patients with HoFH, assess the pharmacokinetics (PK) of evinacumab in
patients with HoFH and evaluate the potential development of anti-evinacumab antibodies.