Second phase II study for zilebesiran,
an RNAi therapeutic for the treatment of hypertension
Alnylam Pharmaceuticals, a leading RNAi therapeutics company, has initiated KARDIA-2 (NCT05103332), a global Phase 2 study to evaluate the efficacy and safety of zilebesiran (formerly known as ALN-AGT), an investigational subcutaneous RNAi therapeutic targeting liver-expressed angiotensinogen (AGT) in development for the treatment of hypertension. KARDIA-2 will evaluate the efficacy and safety of zilebesiran administered biannually as a concomitant therapy in patients whose blood pressure is not adequately controlled by standard of care antihypertensive medications.
KARDIA-2 is the second Phase 2 study evaluating zilebesiran in hypertension, with KARDIA-1, announced earlier this year, assessing zilebesiran as monotherapy across different doses administered quarterly and biannually. This Phase 2 trial is a randomized, double-blind (DB), placebo-controlled study to evaluate the efficacy and safety of zilebesiran used as a concomitant therapy in adults with hypertension despite treatment with standard of care antihypertensive medications. This global, multicenter trial will enroll approximately 800 adults with hypertension. Patients who meet all inclusion/exclusion criteria during a screening period will be randomized to receive open-label therapy with olmesartan, amlodipine or indapamide as their protocol-specified background antihypertensive medication during a run-in period of at least four weeks. Following the run-in period, eligible patients will be randomized 1:1 to receive 600 mg zilebesiran or placebo concomitantly with their protocol-specified background antihypertensive medication during a 6-month DB period. After three months, additional conventional oral antihypertensives may be added to the protocol-specified background antihypertensive medication for elevated blood pressure. Once the DB period has concluded, protocol-specified background antihypertensive medications will be discontinued, and patients may be eligible to participate in a separate zilebesiran open-label extension study. KARDIA-2 has been activated at clinical sites in the U.S. and will be conducted at approximately 80 clinical study centers worldwide.
09/11/2021
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