This clinical trial is focused on studying a condition called Heterozygous Familial Hypercholesterolemia, which is a genetic disorder that causes high levels of low-density lipoprotein cholesterol (LDL-C), often referred to as “bad cholesterol.” The study is specifically for children aged 6 to under 12 years who have this condition. The treatment being tested is a medication called Inclisiran, which is also known by its code name KJX839. Inclisiran is given as an injection and is designed to help lower LDL-C levels in the blood.
The purpose of the study is to evaluate the safety and effectiveness of Inclisiran in reducing LDL-C levels in children with this condition. The study is divided into two parts. In the first year, participants will receive either Inclisiran or a placebo, which is a substance with no active medication. In the second year, all participants will receive Inclisiran. The study will monitor changes in LDL-C levels and other health markers over time to assess the impact of the treatment.
Throughout the study, participants will have regular check-ups to track their health and any changes in their cholesterol levels. The study aims to provide valuable information on how well Inclisiran works in children with Heterozygous Familial Hypercholesterolemia and to ensure that it is safe for use in this age group. This research could lead to better treatment options for managing high cholesterol in children with this genetic condition.



Austria
Belgium
Czechia
France
Germany
Greece
Hungary
Italy
Poland
Portugal
Spain
The Netherlands