ong-term safety and tolerability of inclisiran in participants with heterozygous familial hypercholesterolaemia or homozygous familial hypercholesterolaemia who have completed the adolescent ORION-16 or ORION-13 studies

Phase 1

Recruiting

Conditions: Familial hypercholsterolemia
MedDRA version: 20.0Level: LLTClassification code: 10054380Term: Familial hypercholesterolemia Class: 10010331
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: CTIS2023-507278-41-00

Lead Sponsor: ovartis Pharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 134

Inclusion Criteria

Male and female participants with a diagnosis of HeFH or HoFH who completed the ORION-16 or ORION-13 studies, meaning the participant received the last dose of study drug and completed the final study visit as per applicable protocol, Per investigator`s clinical judgment, participant derived benefit from treatment with inclisiran in the ORION-16 or ORION-13 studies, Continuing current lipid-lowering therapies (such as e.g. statin and/or ezetimibe) from the feeder study with no planned medication or dose change during study participation

Exclusion Criteria

Participants who in the preceding 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, Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH;Secondary Objective: To evaluate the long-term effect of inclisiran treatment on LDL-C levels;Primary end point(s): Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) (incidence, severity, relationship to study drug and discontinuation due to TEAEs); vital signs; growth; laboratory parameters

Secondary Outcome Measures