Novo Nordisk cardiovascular disease drug flunks phase 3 trial

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Novo Nordisk said July 31 that its experimental medication, ziltivekimab, failed to reduce major adverse cardiovascular events in a phase 3 trial. 

The monthly medication, 15 milligrams of ziltivekimab, was part of a double-blind study with more than 6,300 participants with atherosclerotic cardiovascular disease, chronic kidney disease and inflammation. Major adverse cardiovascular events were defined as cardiovascular death, non-fatal heart attack or non-fatal stroke. 

Overall rates of adverse events and serious adverse events were similar across the placebo and treatment cohorts, according to a Novo Nordisk news release. 

The trial “was designed to test whether inhibition of the IL-6 pathway could translate reductions in cardiovascular inflammation into fewer major cardiovascular events,” Martin Lange, MD, PhD, executive vice president, chief scientific officer and head of research and development at Novo Nordisk, said in a statement. “Although ziltivekimab produced the expected biological effect, this did not result in MACE benefits in this population.”

The drug company is investigating ziltivekimab for two other indications — heart failure and post-acute heart attack — and Novo Nordisk said it expects those study’s results to be available in the first half of 2027.

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