Phase 2 study of Zilebesiran met primary endpoint: Roche,Alnylam

The Phase 2 trial KARDIA-1 is a randomised, double-blind, placebo-controlled, multi-centre global dose-ranging study designed to evaluate the efficacy and safety of zilebesiran as monotherapy in adults with mild-to-moderate hypertension. The study enrolled 394 adults representing a diverse patient population with untreated hypertension or who were on stable therapy with one or more anti-hypertensive medications (after a washout period).

Hypertension is a growing global health crisis responsible for around 10 million deaths worldwide each year. Approximately one in three adults are living with hypertension globally, with up to 80% of individuals remaining uncontrolled despite the availability of several classes of oral anti-hypertensive treatments leaving them at an increased risk of cardiovascular, cerebrovascular and renal disease.

Earlier this year, Roche entered the partnership with Alnylam to co-develop and co-commercialise zilebesiran. The KARDIA study program also includes the Phase 2 study KARDIA-2 of zilebesiran used in combination with one of three standard classes of anti-hypertensive medications which completed enrollment in June 2023. The topline results of KARDIA-2 are expected in early 2024.