This study is researching an experimental drug called alirocumab, referred to as "study drug". In the United States, alirocumab is approved for the treatment of hypercholesterolemia (high blood cholesterol levels). The aim of the study is to see how safe and effective alirocumab is when given weekly to adult participants who have hypercholesterolemia. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug once a week * How much study drug is in the blood at different times
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
420
Administered per the protocol
Pinnacle Research Group
Anniston, Alabama, United States
RECRUITINGCullman Clinical Trials
Cullman, Alabama, United States
RECRUITINGAnaheim Clinical Trials
Anaheim, California, United States
RECRUITINGCenexel CNS
Los Alamitos, California, United States
Percent change in LDL-C
Time frame: From Baseline through Week 12
Concentrations of total alirocumab in serum
Time frame: Through Week 20
Concentrations of free Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) in serum
Time frame: Through Week 20
Percent change in LDL-C
Time frame: From Baseline through Week 8
Percent change in total cholesterol
Time frame: From Baseline through Week 12
Percent change in non-High-Density Lipoprotein-Cholesterol (HDL-C)
Time frame: From Baseline through Week 12
Percent change in HDL-C
Time frame: From Baseline through Week 12
Percent change in triglycerides
Time frame: From Baseline through Week 12
Percent change in Apolipoprotein B (ApoB)
Time frame: From Baseline through Week 12
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Through Week 20
Severity of TEAEs
Time frame: Through Week 20
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Diablo Clinical Research - Flourish Research
Walnut Creek, California, United States
RECRUITINGTampa Bay Medical Research
Clearwater, Florida, United States
RECRUITINGSouthwest General Healthcare Center
Fort Myers, Florida, United States
RECRUITINGPrecision Clinical Research
Sunrise, Florida, United States
RECRUITINGK2 Medical Research The Villages
The Villages, Florida, United States
RECRUITINGCenter for Advanced Research and Education
Gainesville, Georgia, United States
RECRUITING...and 24 more locations