This has been a rough week for the Biotech Market, Novo Nordisk’s fails to reduce heart risk in ZEUS trial

Novo Nordisk (NYSE: NVO) announced that its experimental drug ziltivekimab did not reduce the risk of major adverse cardiovascular events (MACE) in a phase 3 clinical trial, despite producing the expected biological effects.

The ZEUS trial, a double-blind, placebo-controlled study enrolling over 6,300 patients with atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), and elevated inflammation markers, compared once-monthly ziltivekimab 15 mg against placebo. The primary endpoint was a reduction in MACE, defined as cardiovascular death, non-fatal heart attack, or non-fatal stroke. The hazard ratio was 0.99 with a 95% confidence interval of 0.88 to 1.11, indicating no meaningful benefit over placebo.

Ziltivekimab did produce reductions in free IL-6 and high-sensitivity C-reactive protein (hsCRP), confirming target engagement, but these biological effects did not translate into fewer cardiovascular events.

“Although ziltivekimab produced the expected biological effect, this did not result in MACE benefits in this population,” said Martin Holst Lange, executive vice president and chief scientific officer at Novo Nordisk.