Press release
Alnylam Announces First Patient Dosed in ZENITH Global Phase 3 Cardiovascular Outcomes Trial of Zilebesiran
- Global Cardiovascular Outcomes Trial will Enroll ~11,000 Patients Across 35 Countries to Evaluate Zilebesiran as a Novel Biannual Treatment - - Trial to
About this update from Alnylam Pharmaceuticals, Inc.
[{"type":"text","content":"\n- Global Cardiovascular Outcomes Trial will Enroll ~11,000 Patients Across 35 Countries to Evaluate Zilebesiran as a Novel Biannual Treatment -\n\n\n- Trial to Assess Zilebesiran in Patients with Uncontrolled Hypertension with Either Established or at High Risk of Cardiovascular Disease -\n\n\n- Milestone Payment of $300 Million Triggered Under Global Collaboration and License Agreement with Partner Roche -\n\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAlnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the first patient has been dosed in ZENITH (ZilebEsiraN CardIovascular OuTcome Study in Hypertension), a global Phase 3 cardiovascular outcomes trial (CVOT) designed to evaluate the potential of zilebesiran, an investigational biannual subcutaneously administered RNAi therapeutic, to reduce the risk of major adverse cardiovascular (CV) events in patients with uncontrolled hypertension. Zilebesiran works by targeting liver-expressed angiotensinogen (AGT), the most upstream precursor in the Renin-Angiotensin-Aldosterone System (RAAS), which plays a key role in blood pressure regulation and impacts CV and renal health.\n\n\n“The first patient dosed in our pivotal global Phase 3 cardiovascular outcomes trial, ZENITH, marks a major milestone in our commitment to exploring the ability of zilebesiran to reduce cardiovascular risk in patients with uncontrolled hypertension, a leading addressable cause of cardiovascular morbidity and mortality worldwide,” said Weinong Guo, MD, PhD, Senior Vice President, Clinical Research at Alnylam. “By targeting the most upstream precursor of the RAAS, zilebesiran offers the potential for sustained, 24-hour, continuous control of blood pressure with biannual dosing in patients with high unmet need. It is one of the many novel RNAi therapeutics in our pipeline that demonstrates our long-term commitment to transforming the treatment of cardiovascular disease and improving outcomes for patients.”\n\n\nIn this global multi-center Phase 3 ZENITH CVOT (NCT07181109), Alnylam and its partner Roche will enroll approximately 11,000 patients in 35 countries to evaluate zilebesiran (300 mg) administered every six months compared to placebo in patients with uncontrolled hypertension with either established CV disease or at high risk for CV disease despite the use ...