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
Second phase II study for zilebesiran, an RNAi therapeutic for the treatment of hypertension
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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