Merck Initiates Phase 3 Study Of VERQUVO In Chronic Heart Failure And Reduced Ejection Fraction

(RTTNews) - Merck & Co Inc.(MRK), known as MSD outside the U.S. and Canada, announced Thursday the initiation of VICTOR (VerICiguaT in adults with ChrOnic heart failure and Reduced ejection fraction), a pivotal Phase 3 randomized, placebo-controlled cardiovascular clinical trial of VERQUVO (vericiguat) in patients with chronic heart failure and reduced ejection fraction of 40% or less who have not had a recent worsening heart failure event.

The recruitment for the VICTOR trial has begun and it is slated to enroll approximately 6,000 adults with chronic heart failure and reduced ejection fraction who have not been hospitalized for heart failure for 6 months or received outpatient IV diuretic use within 3 months prior to randomization.

The primary efficacy endpoint is the time to first event of cardiovascular death or hospitalization for heart failure.

Based on the VICTORIA study, VERQUVO (vericiguat) was approved by the U.S. Food and Drug Administration (FDA) in January 2021 to reduce the risk of cardiovascular death (CVD) and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient intravenous (IV) diuretics, in adults with symptomatic chronic heart failure and ejection fraction less than 45%.

Like the VICTORIA trial, Merck and Bayer AG will serve as co-sponsors for the VICTOR trial. The study will be executed by Merck. VICTOR is expected to take 39 months to complete, and the trial will include patients from 34 countries at approximately 500 sites around the world.