Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol

Inclusion criteria

• Male or female participants ≥18 years of age.
• History of ASCVD (coronary heart disease [CHD], cardiovascular disease [CVD], or peripheral arterial disease [PAD]).
• Serum LDL-C ≥1.8 millimole (mmol)/liter (L) (≥70 mg/dL).
• Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening.
• Participants on statins should be receiving a maximally tolerated dose.
• Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins.
• Subjects on lipid-lower therapies (such as a statin and/or ezetimibe) should be on a stable dose for ≥30 days before screening with no planned medication or dose change during study participation.

Exclusion criteria

• New York Heart Association (NYHA) class IV heart failure.
• Uncontrolled cardiac arrhythmia
• Uncontrolled severe hypertension
• Active liver disease
• Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (for example, combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion:

• Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age.
• Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.
• Women who are surgically sterilized at least 3 months prior to enrollment.
• Males who are unwilling to use an acceptable method of birth control during the entire study period (such as condom with spermicide).
• Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.
• Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.