Key Inclusion criteria:

• Male and female participants 18 to ≤80 years of age at Screening visit
• Established ASCVD, defined as documented coronary heart disease (CHD), cerebrovascular disease (CVD), or peripheral arterial disease (PAD) at Screening visit
• On stable dose of local guideline recommended lipid lowering therapy for at least 30 days prior to Screening visit
• Participants must successfully complete the run-in period of background inclisiran treatment in order to be randomized
• On standard of care (SoC) treatment for other CVD risk factors including hypertension and diabetes for at least 30 days prior to Randomization/Baseline visit
• Central laboratory reported Lp(a) ≥175 nmol/L at Screening visit
• Central laboratory reported LDL-C >70 mg/dL (or >1.8 mmol/L) at Screening visit

Key Exclusion Criteria:

• Prior treatment with inclisiran

• Any other PCSK9 inhibitor (e.g., evolocumab, alirocumab) use within 4 months prior to Screening visit

• Uncontrolled hypertension at Randomization/Baseline visit

• Heart failure New York Heart Association (NYHA) class IV at Screening visit or at Randomization/Baseline visit (Day 1)

• Triglycerides ≥400 mg/dL at Screening visit

• History of malignancy of any organ system within the past 5 years

• Myocardial infarction, stroke or other major bleeding, coronary or lower limb re vascularization, major cardiac or non-cardiac surgery between Screening visit and Randomization/Baseline visit (Day 1)

• Central laboratory reported platelet count <140,000 per mm3

• Active liver disease or hepatic dysfunction at Screening visit

• Significant kidney disease at Screening visit

• Pregnant or nursing women at Screening visit

• Any uncontrolled chronic or serious medical condition which may pose an immediate risk to clinical stability of the study participant at Screening visit

  • Other protocol-defined inclusion/exclusion criteria may apply.