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

Inclusion Criteria:

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

1. Evidence of atherosclerotic coronary artery disease (CAD) on computertomography (CT) or invasive coronary angiogram defined as a coronary arterystenosis ≥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-enhancingfactors.

• 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 4weeks prior to the screening visit and the participant should be willing to remainon this background therapy for the entire duration of the study.

Exclusion Criteria:

• History of major ASCVD event.

• History of, or planned, ischemia-driven revascularization in a coronary orextracoronary arterial bed prior to randomization

• Absence of coronary atherosclerosis on a CT angiogram or an invasive coronaryangiogram in the 2 years prior to randomization

• Coronary artery calcium (CAC) score of 0 obtained in the 2 years prior torandomization

• Active liver disease or hepatic dysfunction

• Previous, current, or planned treatment with a monoclonal antibody (mAb) directedtoward 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 ofcontraception while taking study treatment which includes for 6 months after laststudy drug administration

Other protocol-defined inclusion/exclusion criteria may apply.