Study to assess the LDL-C lowering efficacy of different doses of LIB003 administered every 4 weeks in subjects on stable statin and/or ezetimibe therapy
Randomized, Double-Blind, Placebo-Controlled, Phase 2 study to assess the LDL-C lowering efficacy at Week 12 of various doses of LIB003 administered subcutaneously (SC) every 4 weeks (Q4W) in patients with hypercholesterolemia on stable diet and oral LDL-C-lowering drug therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
81
LIB003 or placebo
Midwest Institute For Clinical Research
Indianapolis, Indiana, United States
Louisville Metabolic and Atherosclerosis Research Center
Louisville, Kentucky, United States
Sterling Research Group
Cincinnati, Ohio, United States
The Lindner Research Center
Cincinnati, Ohio, United States
Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 12
Change in serum LDL-C from baseline after 12 weeks
Time frame: baseline to 12 weeks
The incidence and severity of treatment emergent adverse events (TEAEs)
safety and tolerability will be based on the incidence and severity of treatment emergent adverse events
Time frame: baseline to 12 weeks
Percent reduction in apolipoprotein B (Apo B) at week 12
Change in serum Apo B from baseline after 12 weeks
Time frame: baseline to 12 weeks
Percent reduction in lipoprotein (a) [Lp(a)] at week 12
Change in serum Lp(a) from baseline after 12 weeks
Time frame: baseline to 12 weeks
Percent reduction in free PCSK9 at week 12
Change in serum free PCSK9 from baseline after 12 weeks
Time frame: baseline to 12 weeks
Presence of anti LIB003 antibodies (ADAs)
Measurement of ADAs at baseline and various intervals
Time frame: baseline to 12 weeks
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Metabolic & Atherosclerosis Research Center (MARC)
Cincinnati, Ohio, United States