This clinical trial is focused on studying the long-term safety and tolerability of a medication called inclisiran in individuals with a condition known as familial hypercholesterolemia. Familial hypercholesterolemia is a genetic disorder that causes high levels of cholesterol in the blood, which can increase the risk of heart disease. The study involves participants who have already completed previous studies named ORION-16 or ORION-13. Inclisiran, also known by its code name KJX839, is administered as a solution for injection under the skin.

The purpose of this study is to evaluate how well participants tolerate inclisiran over a long period. Participants will continue their current cholesterol-lowering treatments, such as statins or ezetimibe, without any planned changes in medication or dosage during the study. The study will monitor any side effects or adverse events that occur, as well as changes in vital signs, growth, and laboratory test results.

Throughout the study, researchers will also measure changes in LDL cholesterol levels, which is often referred to as “bad” cholesterol, from the beginning of the study to the end. This will help determine the effectiveness of inclisiran in managing cholesterol levels in participants with familial hypercholesterolemia. The study is designed to provide valuable information on the long-term use of inclisiran for individuals with this genetic condition.