A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.

• At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following:

  1. Evidence of atherosclerotic coronary artery disease (CAD) on computer tomography (CT) or invasive coronary angiogram defined as a coronary artery stenosis ≥20% but <50% in the left main coronary artery or stenosis ≥20% but <70% in any other major epicardial coronary artery, or
  2. Coronary artery calcium (CAC) score obtained by CT-scan ≥100 Agatston units, or
  3. High 10-year ASCVD risk ≥20%, or
  4. Intermediate 10-year ASCVD risk 7.5% - <20% with at least 2 risk-enhancing factors.

• LDL-C ≥70 mg/dL (≥1.81 mmol/L) but <190 mg/dL (<4.91 mmol/L) at the screening visit. If on a background lipid lowering therapy, the dose should be stable for at least 4 weeks prior to the screening visit and the participant should be willing to remain on this background therapy for the entire duration of the study.

• History of major ASCVD event.
• History of, or planned, ischemia-driven revascularization in a coronary or extracoronary arterial bed prior to randomization
• Absence of coronary atherosclerosis on a CT angiogram or an invasive coronary angiogram in the 2 years prior to randomization
• Coronary artery calcium (CAC) score of 0 obtained in the 2 years prior to randomization
• Active liver disease or hepatic dysfunction
• Previous, current, or planned treatment with a monoclonal antibody (mAb) directed toward proprotein convertase subtilisin/kexin type 9 (PCSK9) (e.g., evolocumab, alirocumab)
• Pregnant or nursing (lactating) women
• Women of childbearing potential unless they are using effective methods of contraception while taking study treatment which includes for 6 months after last study drug administration

Other protocol-defined inclusion/exclusion criteria may apply.