Merck (MSD) has commenced the Phase III VICTOR clinical trial of Verquvo (vericiguat) in chronic heart failure patients who also have reduced ejection fraction (HFrEF) of 40% or less.
Recruitment of subjects who have not experienced a recent worsening heart failure event is progressing.
The randomised, placebo-controlled trial is anticipated to enrol nearly 6,000 adult patients with chronic HFrEF who were not admitted to the hospital for heart failure for six months or received outpatient intravenous (IV) diuretic use within three months.
Merck and Bayer will co-sponsor the trial while the former will carry out the cardiovascular study.
The trial also intends to enrol subjects from 34 countries at nearly 500 centres worldwide.
The time to the first occurrence of cardiovascular death (CVD) or hospitalisation arising due to heart failure will be the trial’s primary efficacy goal.
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Merck Research Laboratories Global Clinical Development vice-president and Cardiovascular Therapeutic area head Dr Joerg Koglin said: “The initiation of the Phase III VICTOR study reflects our commitment to finding additional options for a chronic heart failure condition that affects more than three million people in the US each year.
“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 III VICTORIA study.”
In January 2021, Verquvo obtained the US Food and Drug Administration (FDA) approval to reduce the CVD and HF-associated hospitalisation risk in adult patients with symptomatic chronic HFrEF below 45%.
The treatment is indicated for such patients who were previously hospitalised for heart failure or required outpatient IV diuretics.
This September, Merck’s Keytruda (pembrolizumab) met the primary goal in the Phase III KEYNOTE-394 trial that enrolled Asian patients having advanced hepatocellular carcinoma.