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# Ziltivekimab Misses Endpoint in Cardiovascular Outcomes Trial
- URL: https://www.fdaweb.com/ziltivekimab-misses-endpoint-in-cardiovascular-outcomes-trial/
- Published: 2026-07-31T12:00:00.000Z
- Updated: 2026-09-14T13:44:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161558

Novo Nordisk says its investigational anti-inflammatory drug ziltivekimab failed to reduce the risk of major adverse cardiovascular events in a late-stage study of patients with cardiovascular disease, chronic kidney disease and inflammation, marking a setback for the company's efforts to develop a new treatment targeting the IL-6 inflammatory pathway.

In the Phase 3 ZEUS trial, which enrolled more than 6,300 patients with atherosclerotic cardiovascular disease, chronic kidney disease and elevated levels of high-sensitivity C-reactive protein (hsCRP), once-monthly ziltivekimab did not significantly reduce the composite risk of cardiovascular death, non-fatal heart attack or non-fatal stroke compared with placebo, according to the company,

Novo Nordisk says that while the monoclonal antibody achieved its intended biological effect by inhibiting the IL-6 inflammatory pathway and lowering circulating IL-6 and hsCRP levels, the reductions in inflammation did not translate into improved cardiovascular outcomes

"ZEUS was designed to test whether inhibition of the IL-6 pathway could translate reductions in cardiovascular inflammation into fewer major cardiovascular events," Novo Nordisk research and development head **Martin Holst Lange** is quoted in a release as saying.

The company says overall rates of adverse events and serious adverse events were similar between the treatment and placebo groups. However, consistent with IL-6 inhibition, serious infections occurred more frequently in patients receiving ziltivekimab. No difference in all-cause mortality was observed, it adds.

The company plans to continue two ongoing Phase 3 cardiovascular outcomes trials of ziltivekimab. The HERMES study is evaluating the drug in patients with heart failure, while the ARTEMIS trial is testing it in patients following an acute myocardial infarction. Both studies are expected to report results in the first half of 2027.

Full results from the ZEUS trial will be presented at a scientific meeting later this year, the company says.