Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients

Inclusion Criteria: * Provision of signed informed consent prior to any study-specific procedure; * Weight of ≥40 kg (88 lb) and body mass index (BMI) ≥16 and ≤42 kg/m2; * Very- high or high risk for CVD as defined in 2019 ESC/EAS Guidelines * High-intensity statin (daily atorvastatin 40/80 or rosuvastatin 20/40) without other acceptable oral lipid lowering treatment plus diet; stable \>4 weeks with LDL-C ≥85 mg/dL and triglycerides ≤400 mg/dL * Women of childbearing potential (WOCBP) must continue using a highly effective form of birth control if sexually active * Males whose partners are of CBP and not using a highly effective form of birth control will either be surgically sterile or agree to use the following forms of contraception, male or female condom with spermicide Exclusion Criteria: * Prior or active clinical condition or acute and/or unstable systemic disease, including cancer, compromising patient inclusion or preclude completion of the study, at the discretion of the Investigator * Homozygous FH * non-high intensity statins, mipomersen, lomitapide, gemfibrozil, and bempedoic acid * PCSK9 mAb within 4 weeks of screening or siRNA within 1 year * Severe renal dysfunction, defined eGFR \<30 ml/min * Recent, within 3 months of screening, atherosclerotic event or intervention * planned cardiac procedure * NYHA class III or IV heart failure * active liver disease * uncontrolled diabetes defined as fasting glucose \>200 mg/dL and HbA1c \> 9% * uncontrolled BP ≥180 mmHg systolic or ≥110 mmHg diastolic;