A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED TRIAL TO EVALUATE THE EFFECT OF 300 MG OF INCLISIRAN SODIUM GIVEN AS SUBCUTANEOUS INJECTIONS IN SUBJECTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HeFH) AND ELEVATED LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C)
Phase of Trial: Phase III
Latest Information Update: 15 Jan 2018
At a glance
- Drugs Inclisiran (Primary)
- Indications Hypercholesterolaemia
- Focus Registrational; Therapeutic Use
- Acronyms ORION-9
- Sponsors The Medicines Company
- 07 Jan 2018 According to an Alnylam Pharmaceuticals media release, The Medicines Company has guided to complete enrollment in the ORION 9, 10, and 11 pivotal studies in early 2018.
- 05 Jan 2018 Status changed from planning to recruiting.
- 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. This trial is expected to begin before the end of 2017.