Trial Profile
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)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 12 Dec 2023
Price :
$35
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At a glance
- Drugs Inclisiran (Primary)
- Indications Hypercholesterolaemia
- Focus Registrational; Therapeutic Use
- Acronyms ORION-5
- Sponsors Novartis Pharmaceuticals; The Medicines Company
- 12 Dec 2023 Results of post hoc analysis assessing the safety and tolerability of inclisiran for treatment of hypercholesterolemia from completed (ORION-1, -3, -5, -9, -10, and -11) and ongoing (ORION-8) trials, published in the Journal of the American College of Cardiology.
- 18 Oct 2023 Primary endpoint has not been met. (Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) from Baseline to Day 150), as per Results published in the Circulation
- 18 Oct 2023 Results published in the Circulation