This study is to assess LDL-C reductions at Week 52 with monthly (Q4W \[≤31 days\]) dosing of LIB003 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with very-high risk for CVD on a stable diet and oral LDL-C lowering drug therapy.
Randomized, double-blind, placebo-controlled, Phase 3 study of 52 weeks duration. Patients who fulfill the inclusion and exclusion criteria will be enrolled at up to 60 sites in the United States, Canada, Europe, South Africa, Asia, Australasia, and the Middle East. Patients will be randomized in a 2:1 ratio to LIB003 or placebo. The total study duration will be up to 63 weeks which includes up to a Screening Period and 52 weeks of study drug treatment. Following randomization patients will be dosed and seen in the clinic Q4W (≤31 days).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
900
PCSK9 inhibitor
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 change compared to placebo
Percent change in LS mean from baseline compared to placebo in LDL-C level
Time frame: 52 weeks
mean LDL-C change at week 50 and 52
Percent change in LS mean from baseline compared to placebo in LDL-C level at Weeks 50 and 52
Time frame: 52 weeks
Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 52 weeks
Evaluation of Adverse Events based on MedRA based on ITT population
Time frame: 52 weeks
Free PCSK9 change
Percent change in LS mean from baseline compared to placebo in free PCSK9
Time frame: 52 weeks
Percentage of patients achieving 2019 ESC/EAS LDL-C goals
To assess the effects of LIB003 on the percentage of patients achieving an LDL-C \<40 mg/dL, 55 mg/dL, \<70 mg/dL, and 100 mg/dL
Time frame: 52 weeks
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