Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia

Inclusion Criteria:

• Male or female participants, 6 to <12 years of age at screening

• HeFH diagnosed either by genetic testing or on phenotypic criteria

• Fasting LDL-C >130 mg/dL (3.4 mmol/L) at screening

• For participants 8 to <12 years, on an optimal dose of statin (investigator'sdiscretion) unless statin intolerant, with or without other lipid-lowering therapy (e.g. ezetimibe). For participants <8 years, the use of background lipid-loweringtreatment is based on investigator's discretion.

• Participants on lipid-lowering therapies (such as statin and/or e.g. ezetimibe) mustbe on a stable dose for ≥30 days before screening with no planned medication or dosechanges during study participation.

Exclusion Criteria:

• Previous treatment (within 90 days of screening) with monoclonal antibodies directedtowards PCSK9

• Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome

• Homozygous familial hypercholesterolemia (HoFH)

• Body weight <16 kg at the screening and/or randomization (Day 1) visit

• Active liver disease defined as any known current infectious, neoplastic, ormetabolic pathology of the liver or unexplained alanine aminotransferase (ALT),aspartate aminotransferase (AST) elevation >3x ULN, or total bilirubin elevation >2xULN (except patients with Gilbert's syndrome)

• Pregnant or nursing females

• Recent and/or planned use of other investigational medicinal products or devices