HPS-4/TIMI 65/ORION-4

HPS-4/TIMI 65 ORION-4 will examine the effects of inclisiran, a small interfering RNA (siRNA) that inhibits the synthesis of PCSK9, on cardiovascular outcomes among individuals with atherosclerotic cardiovascular disease. It will be conducted at high-enrolling sites using a streamlined, quality-by-design approach.

ORION on ClinicalTrials.gov

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PUBLICATIONS

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. Am Heart J. 2026 Aug 7:107546. doi: 10.1016/j.ahj.2026.107546. Online ahead of print.