Comparison of LDL-C reductions at Week 12 of monthly (Q4W\[≤ 31 days\]) dosing of LIB003 300 mg administered subcutaneously (SC) to Q4W dosing of evolocumab (Repatha) 420 mg and alirocumab (Praluent) 300 mg in patients with CVD or at high risk for CVD on a stable diet and high intensity statin and other LDL-C-lowering drug therapy.
This is a randomized, open-label Phase 3 study of 12 weeks duration comparing Q4W SC doses of LIB003 300 mg, evolocumab (Repatha) 420 mg and alirocumab (Praluent) 300 mg. Approximately 220 males and females aged ≥18 years who fulfill all of the inclusion and exclusion criteria will be enrolled at up to 25 sites in the United States. Patients will be stratified by baseline LDL-C and randomized in a 2:2:1 ratio to LIB003 (88 patients), Repatha (88 patients) or Praluent (44 patients) administered SC Q4W (≤31 days). The study will consist of a Screening Period and a Treatment Period. The total study duration will be up to 21 weeks which includes up to 9-week Screening Period (depending on period required for washout of PCSK9 mAb and/or intensification of statin treatment) and 12 weeks of study drug treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
204
anti-PCSK9 small binding protein
monoclonal antibody to PCSK9
monoclonal antibody to PCSK9
Sterling Research Group
Cincinnati, Ohio, United States
The Lindner Research Center
Cincinnati, Ohio, United States
Metabolic & Atherosclerosis Research Center (MARC)
Cincinnati, Ohio, United States
LDL-C reduction from baseline at 12 weeks
LS Mean percent change from baseline to week 12
Time frame: 12 weeks
Achieved ESC/EAS LDL-C goals
Percent of patients achieving ESC/EAS 2019 LDL-C target
Time frame: 12 weeks
tolerability and safety of each treatment: injection site reactions
ISR (injection site reactions) after each dose
Time frame: 12 weeks
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