Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol

Two phase 3 trials (ORION 10 and ORION 11) evaluated the efficacy and safety of inclisiran, a small interfering RNA (siRNA) therapeutic that inhibits hepatic PCSK9 synthesis, in patients with elevated LDL cholesterol despite statin therapy. Inclisiran, administered subcutaneously every 6 months, achieved placebo corrected LDL cholesterol reductions of 52.3% (ORION 10) and 49.9% (ORION 11) at day 510, with time adjusted reductions of 53.8% and 49.2%, respectively. Adverse events were similar between groups, though injection-site reactions were more frequent with inclisiran. The results demonstrate sustained LDL cholesterol lowering with a biannual dosing regimen.

Two phase 3 trials (ORION 10 and ORION 11) evaluated the efficacy and safety of inclisiran, a small interfering RNA (siRNA) therapeutic that inhibits hepatic PCSK9 synthesis, in patients with elevated LDL cholesterol despite statin therapy. Inclisiran, administered subcutaneously every 6 months, achieved placebo corrected LDL cholesterol reductions of 52.3% (ORION 10) and 49.9% (ORION 11) at day 510, with time adjusted reductions of 53.8% and 49.2%, respectively. Adverse events were similar between groups, though injection-site reactions were more frequent with inclisiran. The results demonstrate sustained LDL cholesterol lowering with a biannual dosing regimen.