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

Prior treatment

• 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

Other illness

• planned cardiac procedure
• NYHA class III or IV heart failure
• active liver disease

Lab values

• Severe renal dysfunction, defined eGFR \<30 ml/min
• uncontrolled diabetes defined as fasting glucose \>200 mg/dL and HbA1c \> 9%

Other

• Homozygous FH
• non-high intensity statins, mipomersen, lomitapide, gemfibrozil, and bempedoic acid
• PCSK9 mAb within 4 weeks of screening or siRNA within 1 year
• Recent, within 3 months of screening, atherosclerotic event or intervention
• uncontrolled BP ≥180 mmHg systolic or ≥110 mmHg diastolic;

• 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