HPS-4/TIMI 65/ORION-4: A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease: Trial design, recruitment, and baseline characteristics

The ORION-4 trial aims to evaluate the efficacy and safety of inclisiran, a novel siRNA therapy targeting PCSK9, in reducing major adverse cardiovascular events among individuals with pre-existing atherosclerotic cardiovascular disease. With a planned enrollment of approximately 15,000 participants and a follow-up period of at least five years, the study seeks to determine whether inclisiran can significantly lower cardiovascular risks compared to a placebo. Results are expected in early 2027, potentially establishing inclisiran as a scalable treatment option in lipid management.