A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH).
Study Masking: Part A: Open Label Part B: Double Blind
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
58
Administered by subcutaneous injection
Administered by subcutaneous injection
Research Site
New York, New York, United States
Research Site
Cincinnati, Ohio, United States
Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
LDL-C was quantified using the ultracentrifugation method.
Time frame: Baseline and Week 12
Part B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
LDL-C was quantified using the ultracentrifugation method.
Time frame: Baseline and Week 12
Part A: Change From Baseline in LDL-C at Week 12
LDL-C was quantified using the ultracentrifugation method.
Time frame: Baseline and Week 12
Part A: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Time frame: Baseline and Week 12
Part A: Percent Change From Baseline in Apolipoprotein B at Week 12
Time frame: Baseline and Week 12
Part A: Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12
Time frame: Baseline and Week 12
Part A: Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
Time frame: Baseline and Week 12
Part A: Percentage of Participants With 15% or Greater Reduction in LDL-C From Baseline at Week 12
LDL-C was quantified using the ultracentrifugation method.
Time frame: Baseline and Week 12
Part A: Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) at Week 12
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Research Site
Brussels, Belgium
Research Site
La Louvière, Belgium
Research Site
London, Ontario, Canada
Research Site
Chicoutimi, Quebec, Canada
Research Site
Brno, Czechia
Research Site
Hradec Králové, Czechia
Research Site
Uherské Hradiště, Czechia
Research Site
Dijon, France
...and 11 more locations
Time frame: Baseline and Week 12
Part B: Percent Change From Baseline in LDL-C at the Mean of Weeks 6 and 12
LDL-C was quantified using the ultracentrifugation method.
Time frame: Baseline and Weeks 6 and 12
Part B: Percent Change From Baseline in Apolipoprotein B at Week 12
Time frame: Baseline and Week 12
Part B: Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 6 and 12
Time frame: Baseline and Weeks 6 and 12
Part B: Percent Change From Baseline in Lipoprotein (a) at Week 12
Time frame: Baseline and Week 12
Part B: Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 6 and 12
Time frame: Baseline and Weeks 6 and 12