New heart drug targeting inflammation falls short in clinical trial

Michael Walter | August 06, 2026 | Cardiovascular Business | Acute Coronary Syndromes

A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]

Novo Nordisk has announced that ziltivekimab, an investigational drug that targets inflammation, failed to improve cardiovascular outcomes in patients with atherosclerotic cardiovascular disease (ASCVD) in the ZEUS clinical trial.

ZEUS was a double-blind study comparing ziltivekimab with a placebo in more than 6,300 patients who presented with ASCVD, chronic kidney disease and inflammation. Participants took one dose per month of either 15 mg of ziltivekimab or a placebo. The study’s primary outcome was major adverse cardiovascular events (MACEs), a composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke.

Ziltivekimab did significantly reduce inflammation as measured by IL-6 and high-sensitivity C-reactive protein (hsCRP) levels. However, this was not associated with the reduced MACE rate researchers had been hoping to uncover.

“ZEUS was designed to test whether inhibition of the IL-6 pathway could translate reductions in cardiovascular inflammation into fewer major cardiovascular events,” Martin Holst Lange, executive vice president, chief scientific officer and head of R&D at Novo Nordisk, said in a statement. “Although ziltivekimab produced the expected biological effect, this did not result in MACE benefits in this population. While ziltivekimab did not achieve the MACE benefit we had hoped for, this does not change our strategic commitment to cardiovascular disease. The study provides important scientific evidence that will inform our ongoing cardiovascular research and the development of treatments for patients who continue to face substantial unmet need.”

Full results from ZEUS will be presented at a future scientific conference. In the meantime, two additional clinical trials with mythical names—HERMES and ARTEMIS—are still ongoing. Those studies are focused on ziltivekimab’s ability to treat patients with heart failure and acute myocardial infarction, respectively. First results are expected in early 2027.

Inflammation still seen as a critical path to prevention

Cardiologists and cardiac imaging specialists have been focused more and more on inflammation in recent years as a way to identify high-risk patients. The American College of Cardiology even issued a scientific statement on the topic in late 2025, highlighting the fact that more and more studies have linked inflammation to ASCVD. Many experts say coronary artery inflammation increases residual risk of heart attacks in patients, and research in recent years has focused ways to better identify and treat it.

The early ZEUS results may have been negative, but Novo Nordisk and other pharmaceutical companies have other trials and investigational drugs in development seeking possible new ways to target inflammation and help patients reduce their risk of adverse outcomes.