A cardiovascular outcomes trial in subjects with ASCVD and/or risk equivalents, such as diabetes, to determine the effects of LDL-C lowering with inclisiran on cardiovascular outcomes
Phase of Trial: Phase III
Latest Information Update: 25 Jan 2018
At a glance
- Drugs Inclisiran (Primary)
- Indications Hypercholesterolaemia
- Focus Registrational; Therapeutic Use
- Acronyms ORION-4
- Sponsors The Medicines Company
- 25 Jan 2018 According to The Medicines Company media release, the company anticipate completion of the trial to include the results in an NDA planned for the end of 2019.
- 25 Jan 2018 According to The Medicines Company media release, following 6 months of treatment to provide data for HoFH as part of a comprehensive LDL-C lowering program in a planned NDA and MAA submission.
- 07 Jan 2018 According to an Alnylam Pharmaceuticals media release, the company expects to initiate enrollment in this trial in mid-2018.