A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED TRIAL TO EVALUATE THE EFFECT OF 300 MG OF INCLISIRAN SODIUM GIVEN AS SUBCUTANEOUS INJECTIONS IN SUBJECTS WITH ATHEROSCLEROTIC CARDIOVASCULAR DISEASE (ASCVD) OR ASCVD-RISK EQUIVALENTS AND ELEVATED LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C)
Phase of Trial: Phase III
Latest Information Update: 06 Nov 2017
At a glance
- Drugs Inclisiran (Primary)
- Indications Hypercholesterolaemia
- Focus Registrational; Therapeutic Use
- Acronyms ORION-11
- Sponsors The Medicines Company
- 06 Nov 2017 According to The Medicines Company media release, the phase III program for inclisiran comprises four trials ORION-5, ORION-9, ORION-10 and ORION-11. The data from these trials will support the submission of a New Drug Application (NDA) in the United States and a Marketing Authorization Application (MAA) in the European Union at or around the end of 2019.
- 06 Nov 2017 According to The Medicines Company media release, patient dosing commenced on 1 Nov. Professor Kausik Ray, Professor of Public Health, Imperial College London, United Kingdom, and Honorary Consultant Cardiologist, Imperial College NHS Trust, is the principal investigator of this trial.
- 06 Nov 2017 Status changed from planning to recruiting, according to The Medicines Company media release.