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: 07 Jan 2019
At a glance
- Drugs Inclisiran (Primary)
- Indications Hypercholesterolaemia
- Focus Registrational; Therapeutic Use
- Acronyms ORION-11
- Sponsors The Medicines Company
- 07 Jan 2019 According to The Medicines Company media release, patients receive their fourth and final dose of study medication and data read-out expected in the second half of 2019
- 07 Jan 2019 According to The Medicines Company media release, At the time of the IDMC review, all randomized patients had been treated with three doses, and approximately 2,000 patients had completed a follow-up visit 60-days after the third dose of study medication. To date, more than 2,450 patient-years of inclisiran safety data have been accumulated in the ORION program.
- 07 Jan 2019 According to The Medicines Company media release, the 5th review of un-blinded safety and efficacy data by the Independent Data Monitoring Committee (IDMC) for inclisiran Phase 3 trials (ORION-9, ORION-10 and ORION-11), has been completed and recommended to continue the trials as designed and conducted, without modification.