Trial intelligence / Profile preview

ORION-8: Long-term Extension of Inclisiran in High CV Risk and Elevated LDL-C

NCT03814187Phase 3Completed

Sponsor
Novartis
Start
Apr 2019
Primary completion
Feb 2023
Modality
Antisense DNA, Conjugated siRNA, MicroRNA (miRNA)
Countries
13
01

Overview

Phase 3, open-label, single-arm trial of inclisiran in atherosclerotic cardiovascular disease (ASCVD), heterozygous familial hypercholesterolemia (HeFH), hypercholesterolemia and 1 more, sponsored by Novartis. Primary endpoints: Proportion of Subjects Achieving Global Lipid Targets for Their Level of ASCVD Risk at Day 1080 and Incidence of Treatment-emergent Adverse Events at Day 1080. Started Apr 2019; status: completed.

02

Drugs

inclisiran
03

Conditions

atherosclerotic cardiovascular disease (ASCVD)heterozygous familial hypercholesterolemia (HeFH)hypercholesterolemiahomozygous familial hypercholesterolemia (HoFH)

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