This randomized, double-blind, placebo-controlled, dose-ranging multicenter study (Alnylam Pharmaceuticals) aimed to evaluate the effect of ALN-AGT01 (zilbesiran) on systolic and diastolic blood pressure in patients with mild to moderate hypertension. 394 participants were enrolled in the trial and were randomised to receive either ALN-AGT01 or placebo. At 6 months, placebo participants were randomized to receive one of the initial ALN-AGT01 regimens until the end of the 12-month treatment period.
The primary endpoint is the change from baseline at three months in 24-hour mean systolic blood pressure (SBP) assessed by ambulatory blood pressure monitoring (ABPM).
Results suggest that single subcutaneous doses of zilbesiran showed clinically significant reductions in 24-hour mean SBP as compared to placebo at 3 months, which was sustained through to month 6. An encouraging safety profile was demonstrated across this period, with low rates of serious or severe adverse events, and mild to moderate drug-related events observed across all zilbesiran regimens. Study of the drug will continue in the ongoing KARDIA-2 phase 2 study.
Recorded on-site at AHA 2023, Philadelphia.
Supported by an educational grant from Novo Nordisk Inc. This content is not intended for UK HCPs.