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