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)
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 23 Dec 2018
At a glance
- Drugs Inclisiran (Primary)
- Indications Hypercholesterolaemia
- Focus Registrational; Therapeutic Use
- Acronyms ORION-9
- Sponsors The Medicines Company
- 01 Oct 2018 According to The Medicines Company media release, data read-out expected in Q2/2019.
- 31 Aug 2018 Biomarkers information updated
- 27 Jun 2018 According to The Medicines Company media release, the Independent Data Monitoring Committee (IDMC) under a planned review of the ongoing inclisiran Phase III trials- ORION-9, ORION-10 and ORION-11, has recommended that the trials continue as designed and conducted, without modification. The IDMC's recommendation was based on its review of unblinded safety and efficacy data from the trials.