A phase III, prospective study to evaluate the safety and efficacy of ALN-PCSsc in patients with hypercholesterolemia
Phase of Trial: Phase III
Latest Information Update: 09 Aug 2017
At a glance
- Drugs Inclisiran (Primary)
- Indications Hypercholesterolaemia
- Focus Registrational; Therapeutic Use
- Acronyms ORION-4
- Sponsors The Medicines Company
- 09 Aug 2017 According to an Alnylam Pharmaceuticals media release, the Company intends to initiate this trial in late-2017.
- 26 Apr 2017 According to The Medicines Company media release, this trial is a part of the phase III program for inclisiran, which is designed to support the NDA submission anticipated at or around the end of 2019. The Phase III program will comprise clinical trials in subjects with atherosclerotic cardiovascular disease (ASCVD) and familial hypercholesterolemia (FH), and will collectively enroll approximately 3,000 subjects randomized to treatment with inclisiran (1,500) or placebo (1,500).
- 08 Jan 2017 According to The Medicines Company media release, company expects discussion with regulatory authorities regarding the Phase 3 development plan for inclisiran prior to the initiation of this trial.