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

Last Update: Jul 10, 2024

An Open-label, Single Arm, Multicenter Extension Study to Evaluate Long-term Safety and Tolerability of Inclisiran in Participants With Heterozygous or Homozygous Familial Hypercholesterolemia Who Have Completed the Adolescent ORION-16 or ORION-13 Studies (VICTORION-PEDS-OLE)

ClinicalTrials.gov Identifier:

NCT05682378

Novartis Reference Number:CKJX839C12001B

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

The purpose of this open-label, single arm, multicenter extension study is to evaluate
the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who
have completed the ORION-16 or ORION-13 studies. This is an open-label, single arm, multicenter study designed to evaluate long-term
safety and tolerability of inclisiran. In addition, the study will provide participants
the opportunity to have continued access to treatment with inclisiran.

Condition

Heterozygous or Homozygous Familial Hypercholesterolemia

Phase

Phase3

Overall Status

Recruiting

Number of Participants

165

Start Date

Feb 10, 2023

Completion Date

Dec 01, 2027

Gender

All

Age(s)

12 Years - (Child, Adult, Older Adult)

Interventions

Drug

Inclisiran

Inclisiran sodium 300mg (equivalent to 284mg inclisiran*) in 1.5mL solution administered subcutaneously in pre-filled syringe

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