Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Adolescent ORION-16 or ORION-13 Studies

Launched by NOVARTIS PHARMACEUTICALS · Dec 27, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety and tolerability of a medication called inclisiran in people who have a condition known as Familial Hypercholesterolemia (HeFH or HoFH). These conditions cause very high cholesterol levels, which can lead to heart problems. The trial is for individuals who have previously participated in two other studies (ORION-16 or ORION-13) and found inclisiran helpful for their condition.

To take part in this study, participants must be male or female, diagnosed with HeFH or HoFH, and have completed the earlier studies showing a benefit from inclisiran. However, those who had serious side effects or stopped the earlier studies for any reason are not eligible. While participating, individuals will continue to receive inclisiran and be monitored for any long-term effects. This study is currently recruiting participants of all ages, so if you or a family member might qualify, it could be a chance to contribute to important research on cholesterol management.

Gender

ALL

Eligibility criteria

• Key inclusion:
• • Male and female participants with a diagnosis of HeFH or HoFH who completed the ORION-16 or ORION-13 studies
• • Per investigator's clinical judgment, participant derived benefit from treatment with inclisiran in the ORION-16 or ORION-13 studies
• Key exclusion:
• • Participants who in the feeder inclisiran ORION-16 and ORION-13 studies either screen failed or permanently discontinued from the treatment/study for any reason or had serious safety or tolerability issues related to inclisiran treatment
• • Any uncontrolled or serious disease, or any medical, physical, or surgical condition, that may either interfere with participation in the clinical study or interpretation of clinical study results, and/or put the participant at significant risk