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The ZENITH outcomes trial will enroll 11,000 patients worldwide to evaluate twice-yearly zilebesiran, aiming to improve long-term blood pressure control and reduce cardiovascular risk in uncontrolled hypertension.
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Roche and Alnylam are launching the Phase III ZENITH cardiovascular outcomes trial (CVOT) to evaluate zilebesiran in patients with uncontrolled hypertension. The RNAi therapeutic was designed to reduce the risk of major adverse cardiovascular events in this patient population.
The trial follows the comprehensive Phase II KARDIA program, including KARDIA-1, KARDIA-2, and KARDIA-3, which evaluated the efficacy and safety of zilebesiran in patients on two to four standard antihypertensives.
Roche noted that KARDIA-3 identified the target patient population for Phase III and demonstrated that a single 300 mg subcutaneous dose every six months produced clinically meaningful reductions in office systolic blood pressure at three months with sustained effects at six months. Additionally, analyses from KARDIA-2 and KARDIA-3 showed that combining zilebesiran with a diuretic can provide more robust blood pressure reductions.1
“Zilebesiran has the potential to become a best-in-disease treatment for many patients with uncontrolled hypertension. Its blood pressure-lowering effects and twice-yearly dosing could reduce the risk of serious health complications and death,” said Levi Garraway, MD, PhD, chief medical officer, head, global product development, Roche, in a press release.
Roche stated that zilebesiran showed a favorable safety profile in patients with comorbidities who were already on multiple background treatments, with more than 90% receiving an ACE inhibitor or an angiotensin receptor blocker. The company noted that these results strengthen confidence in the therapy’s potential to be used alongside standard antihypertensive regimens.1
“Detailed analysis of our comprehensive Phase II clinical trials have informed our decision to move zilbesiran into Phase III,” continued Garraway, in the press release. “Despite current treatment options, up to 80% of people with hypertension do not achieve adequate blood pressure control putting them at higher risk of cardiovascular events. Therefore, additional treatment options are needed."
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