Trial Profile

Phase 3 cardiovascular outcomes trial of Zilebesiran

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 30 Oct 2025

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At a glance

30 Aug 2025 According to Genentech media release, this study expected to be initiated by the end of the 2025.
30 Aug 2025 According to Genentech media release, Genentech and Alnylam (Nasdaq: ALNY) today announced the decision to initiate a Phase III cardiovascular outcomes trial (CVOT) to evaluate the ability of zilebesiran,This decision was informed by the comprehensive KARDIA Phase II program, including KARDIA-1, KARDIA-2 and KARDIA-3 study.In particular, KARDIA-3 aimed to define the patient population to be investigated in the Phase III CV outcomes trial.
31 Jul 2025 According to Alnylam Pharmaceuticals media release, the company expects to initiate this trial in second half of 2025 in collaboration with its partner Roche.

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