This study is to assess LDL-C reductions at Week 24 and the mean of Weeks 22 and 24 with monthly Q4W (≤31 days) dosing of LIB003 300 mg administered subcutaneously (SC) compared to placebo in patients 18 years or older with Heterozygous FH on stable diet and oral LDL-C lowering drug therapy.
A randomized, double-blind, placebo-controlled, Phase 3 study of 24 weeks duration. Approximately 600 males and females aged ≥18 years with clinical or genetic heterozygous FH who fulfill the inclusion and exclusion criteria will be enrolled. Patients will be randomized in a 2:1 ratio to LIB003 (400 patients) or placebo (200 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 35 weeks which includes up to an 11-week Screening Period (which may include up to a 8-week washout) and 24 weeks of study drug treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
478
300 mg Q4W
Metabolic & Atherosclerosis Research Center (MARC)
Cincinnati, Ohio, United States
Department of Medicine, Hadassah University Hospital
Jerusalem, Israel
Rabin Medical Center, Beilinson Hospital,
Petah Tikva, Israel
Lipid Clinic, Oslo University Hospital
Oslo, Norway
Change from baseline compared to placebo in LDL-C level
LS mean percent change in LDL-cholesterol compared to placebo
Time frame: 24 weeks
Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities
Incidence of Treatment-Emergent Adverse Events (TEAE) as assessed by Medical Dictionary for Regulatory Activities as mild, moderate or severe compared to placebo
Time frame: 24 weeks
Change in serum free PCSK9 with LIB003 compared to placebo
Change in percent LS mean between LIB003 and placebo
Time frame: 24 weeks
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Carbohydrate and Lipid Metabolism Research Unit
Johannesburg, Gauteng, South Africa
Division of Lipidology, Department of Medicine University of Cape Town
Cape Town, Western Province, South Africa
Ege University Medical School
Izmir, Bornova, Turkey (Türkiye)