At a glance
ClinicalIndex Comparison Record- ✓Confirmed genetic diagnosis of HoFH OR clinical diagnosis (untreated LDL-C >500 mg/dL plus xanthoma before age 10 or heterozygous FH in both parents)
- ✓Fasting LDL-C ≥130 mg/dL (3.4 mmol/L)
- ✓On maximally tolerated dose of statin OR documented intolerance to ≥2 different statins if not on statin
- ✓Stable lipid-lowering therapy (statin and/or ezetimibe) for ≥30 days before screening
- ✕Mipomersen or lomitapide within 5 months of screening
- ✕PCSK9 monoclonal antibody within 90 days of screening
- ✕NYHA class IV heart failure or LVEF <25%
- ✕Major adverse cardiovascular event within 3 months prior to randomization
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Inclisiran Sodium for injection, Placebo, and 1 other intervention for Homozygous Familial Hypercholesterolemia. Completed, enrolled 56 participants across 13 sites in 8 countries.
Detailed 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).
Study Details
Timeline
Interventions
Inclisiran is a synthetic, chemically modified small interfering ribonucleic acid (siRNA) targeting proprotein convertase subtilisin kexin type 9 (PCSK9) messenger ribonucleic acid (mRNA) with a covalently attached triantennary N-acetylgalactosamine (GalNAc) ligand.
Sterile normal saline (0.9% sodium chloride in water for injection)
Sterile normal saline (0.9% sodium chloride in water for injection)