Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction

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.

Inclusion criteria

• Male or female, 18 years of age or older
• Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic cardiovascular disease (ASCVD) event or evidence of ASCVD or without ASCVD but at high risk for ASCVD based on AHA/ACC CVD risk calculator, or aged 40 years and older with diabetes and moderate- to high-intensity statin, or pre-treatment LDL-C 190 mg/dL or greater or heterozygous familial hypercholesterolemia (HeFH)
• Body mass index (BMI) between 18 and 40 kg/m2

Exclusion criteria

• Females of childbearing potential not using or willing to use an effective form of contraception, or pregnant or breastfeeding, or who have a positive serum pregnancy test at screening
• Homozygous familial hypercholesterolemia
• LDL or plasma apheresis within 2 months; lomitapide or mipomersen within 12 months
• Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment
• Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment
• Newly diagnosed or poorly controlled (HbA1c >9%) type 2 diabetes
• Uncontrolled hypertension
• Moderate to severe renal insufficiency
• Elevated liver function test at screening
• Uncontrolled cardiac arrhythmia or prolonged QT on EKG
• A history of prescription drug abuse, illicit drug use, or alcohol abuse