Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C

Inclusion Criteria:

1. Completion on a previously qualifying inclisiran Phase II trial MDCO-PCS-16-01 (ORION-3), or Phase III lipid lowering ORION feeder study [MDCO-PCS-17-03 (ORION-9),MDCO-PCS-17-4 (ORION-10), or MDCO-PCS-17-08 (ORION-11)] meaning the subject receivedthe last dose of study drug and completed the final study visit per applicableprotocol.
2. On current lipid-lowering therapies (such as a statin and/or ezetimibe) from previousstudy with no planned medication or dose change during study participation.
3. Willing and able to give informed consent before initiation of any study-relatedprocedures and willing to comply with all required study procedures.

Exclusion Criteria:

1. Any uncontrolled or serious disease, or any medical or surgical condition, that mayeither interfere with participation in the clinical study, and/or put the subject atsignificant risk [according to investigator's (or delegate's) judgment] if he/sheparticipates in the clinical study.
2. An underlying known disease, or surgical, physical, or medical condition that, in theopinion of the investigator (or delegate) might interfere with interpretation of theclinical study results.
3. Severe concomitant noncardiovascular disease that carries the risk of reducing lifeexpectancy to less than 3 years,
4. Active liver disease defined as any known current infectious, neoplastic, or metabolicpathology of the liver or unexplained alanine aminotransferase (ALT), aspartateaminotransferase (AST), elevation >3x the upper limit of normal (ULN), or totalbilirubin (TBIL) elevation >2x ULN at the last recorded visit in the feeder studyprior to study entry visit.
5. Females who are pregnant or nursing, or who are of childbearing potential andunwilling to use at least one method of acceptable effective contraception (eg, oralcontraceptives, barrier methods, approved contraceptive implant, long-term injectablecontraception, intrauterine device) for the entire duration of the study. Exemptionsfrom this criterion:
6. Women >2 years postmenopausal (defined as 1 year or longer since last menstrualperiod) and more than 55 years of age.
7. Postmenopausal women (as defined above) and less than 55 years of age with anegative pregnancy test within 24 hours of randomization.
8. Women who are surgically sterilized at least 3 months prior to enrollment.
9. Planned use of other investigational medicinal products other than inclisiran ordevices during the course of the study.
10. Any condition that according to the investigator could interfere with the conduct ofthe study, such as but not limited to:
11. Subjects who are unable to communicate or to cooperate with the investigator
12. Unable to understand the protocol requirements, instructions and study-relatedrestrictions, the nature, scope, and possible consequences of the study (including subjects whose cooperation is doubtful due to drug abuse or alcoholdependency)
13. Unlikely to comply with the protocol requirements, instructions, andstudy-related restrictions (eg, uncooperative attitude, inability to return forfollow-up visits, and improbability of completing the study)
14. Have any medical or surgical condition, which in the opinion of the investigatorwould put the subject at increased risk from participating in the study
15. Persons directly involved in the conduct of the study. The above information is not intended to contain all considerations relevant to aparticipant's potential participation in a clinical trial.