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A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH) — ORION-5  

Homozygous Familial Hypercholesterolemia Clinical Trial

Official title:
A Two-Part (Double-Blind Placebo Controlled/Open-Label) Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Subjects With Homozygous Familial Hypercholesterolemia (Hofh) (ORION-5)

Clinical Trial Summary

This study was a Phase III,A two-part (double-blind placebo-controlled/open-label) multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in subjects with homozygous familial hypercholesterolemia (HoFH).

Clinical Trial Description

This study had two sequential parts: - Part 1: 6-month double-blind period in which subjects were randomized to receive either inclisiran or placebo - Part 2: 18-month open-label follow-up period; placebo-treated subjects from Part 1 were transitioned to inclisiran at Day 180 and all subjects who participated in an open-label follow-up period of inclisiran only ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03851705
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 3
Start date February 6, 2019
Completion date September 9, 2021
View Details
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