Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the initiation of VICTOR (VerICiguaT in adults withChrOnicheart 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.
Recruitment for the VICTOR trial has begun. The study 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 (NCT05093933).
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%. The VERQUVO label contains a boxed warning that indicates that VERQUVO should not be administered to pregnant females because it may cause fetal harm. For more information, see "Selected Safety Information" below.
"The VICTOR study will assess initiating vericiguat earlier in the heart failure journeys of certain patients," said Dr. Javed Butler, the Patrick H. Lehan Chair in Cardiovascular Research, and professor and chairman of the department of medicine at the University of Mississippi Medical Center.
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. Every effort is being made to ensure that the patient population studied in the trial represents the diverse nature of people who may be diagnosed with chronic heart failure and reduced ejection fraction of less than 40% who have not had a recent worsening heart failure event.
"The initiation of the Phase 3 VICTOR study reflects our commitment to finding additional options for a chronic heart failure condition that affects more than 3 million people in the U.S. each year," said Dr. Joerg Koglin, vice president, Global Clinical Development and Therapeutic Area Head, Cardiovascular for Merck Research Laboratories. "Along with our partners at Bayer, we look forward to studying vericiguat in a more stable chronic heart failure population than was studied in the Phase 3 VICTORIA study."