Roche and Alnylam Advance Zilebesiran into Phase III Cardiovascular Outcomes Trial

Roche, together with its partner Alnylam, is propelling the RNA interference therapy zilebesiran into a Phase III cardiovascular outcomes trial following compelling Phase II results. At the European Society of Cardiology Congress 2025, data from the KARDIA‑3 study were presented. While the trial did not meet its primary endpoint due to statistical constraints, the 300 mg dose achieved a placebo‑adjusted systolic blood pressure reduction of 5 mmHg at Month 3 (p = 0.0431), with sustained benefits through Month 6.

Safety data were encouraging, and subgroup analysis suggested enhanced benefit when zilebesiran was combined with a diuretic. The comprehensive insights from the KARDIA‑1 through KARDIA‑3 studies guided the decision to launch a global Phase III cardiovascular outcomes trial, targeted for initiation by the end of this year. Zilebesiran is delivered via biannual subcutaneous injections and aims to lower cardiovascular risk in patients with uncontrolled hypertension.