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 ACSVD Risk-Equivalents and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 27 Jun 2018
At a glance
- Drugs Inclisiran (Primary)
- Indications Hypercholesterolaemia
- Focus Registrational; Therapeutic Use
- Acronyms ORION-11
- Sponsors The Medicines Company
- 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.
- 08 Mar 2018 According to The Medicines Company media release, data read-out expected in Q3/2019.
- 25 Feb 2018 The trial has been discontinued in Netherlands.