Novo Nordisk’s ziltivekimab, an investigational human monoclonal antibody that targets the IL-6 ligand, a pro-inflammatory cytokine, to reduce cardiovascular inflammation, did not reduce the risk of major adverse cardiovascular events (MACE) in a Phase 3 trial.
“Although ziltivekimab produced the expected biological effect, this did not result in MACE benefits in this population,” Martin Holst Lange, executive vice president, chief scientific officer and head of Research and Development at Novo Nordisk, said in a press release.
The trial’s primary endpoint showed a hazard ratio (HR) of 0.99 for MACE with a 95% confidence interval of 0.88 to 1.11, indicating no significant difference between ziltivekimab and placebo.
The trial design required the drug to show at least a 20% relative risk reduction at 95% power.
Overall rates of adverse events (AEs) and serious AEs were similar to those observed with placebo, the company said in the release. A higher proportion of participants treated with ziltivekimab had serious infections compared to placebo, consistent with targeting IL-6 inhibition, Novo said.
Two additional ongoing trials investigating ziltivekimab in people with heart failure (HERMES) and in people following an acute heart attack (ARTEMIS) are planned to continue, and data is expected in the first half of 2027.
The company said this outcome will not impact Novo’s previously communicated adjusted operating profit outlook for this year but will result in a non-cash impairment charge in the third quarter of this year.
Full results of this trial will be presented at an upcoming scientific meeting in 2026, the company said.
Novo shares fell about 7.4% in Copenhagen trading the day of the announcement, Novo’s largest single-day stock decline since disappointing results on February 23, when CagriSema failed to show non-inferiority to tirzepatide in the head-to-head REDEFINE 4 trial. Analysts at both Citi and Jefferies noted that the price volatility seemed excessive considering the drug’s small share in Novo’s portfolio.
Novo acquired ziltivekimab in 2020 when it purchased Corvidia Therapeutics, a clinical stage company that spun out from Astra Zeneca in 2015, focused on therapies for cardiorenal diseases, for an upfront payment of $725 million. Novo framed that acquisition as part of its strategy to expand its presence in cardiometabolic disease.
Filed Under: Biotech, Cardiovascular, clinical trials, Drug Discovery, Immunology
