Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia

Inclusion Criteria:

Homozygous Familial Hypercholesterolemia (HoFH) diagnosed by genetic confirmation
Fasting LDL-C >130 mg/dL (3.4 mmol/L) at screening
On maximally tolerated dose of statin (investigator's discretion) with or without other lipid-lowering therapy; stable for ≥ 30 days before screening
Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73 m2 at screening

Exclusion Criteria:

Documented evidence of a null (negative) mutation in both LDLR alleles
Heterozygous familial hypercholesterolemia (HeFH)
Active liver disease
Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome
Major adverse cardiovascular events within 1 month prior to randomization
Previous treatment with monoclonal antibodies directed towards PCSK9 (within 90 days of screening)
Treatment with mipomersen or lomitapide (within 5 months of screening)
Recent and/or planned use of other investigational medicinal products or devices

Other protocol-defined inclusion/exclusion criteria may apply