Novo Nordisk has halted two more late-stage studies of its experimental heart disease drug ziltivekimab, dealing another setback to the Danish drugmaker’s plans to expand beyond its dominant obesity and diabetes businesses. The decision affects the Novo Nordisk heart disease drug trials HERMES and ATHENA in Phase 3, which were testing the drug in people with heart failure and inflammation.
The halt in ziltivekimab drug trials follows the failure of the ZEUS Phase 3 study in July. An independent data monitoring committee concluded that there was a “low likelihood” that the two ongoing trials on ziltivekimab drug would produce a different result from ZEUS.
Novo will, however, continue the ARTEMIS trial, which is testing ziltivekimab in patients recovering from a heart attack, with results expected in the first half of 2027.
What Are The Novo Nordisk Heart Disease Drug Trials?
The Novo Nordisk ziltivekimab drug trial program includes several late-stage studies designed to determine whether reducing inflammation can improve cardiovascular outcomes.
Novo stopped the HERMES and ATHENA phase 3 studies after the independent monitoring committee reviewed available data. The committee determined that continuing the trials was unlikely to produce a substantially different outcome from the earlier ZEUS study.
The two ziltivekimab drug trials had different objectives:
- HERMES enrolled about 4,900 patients with heart failure with mildly reduced or preserved ejection fraction.
- ATHENA enrolled about 673 patients in a similar heart-failure population.
- Both studies evaluated whether ziltivekimab could delay serious heart-failure or cardiovascular outcomes.
Patients in the discontinued Novo Nordisk heart disease drug trials are expected to complete scheduled three-month follow-up visits.
What Is Novo Nordisk Heart Disease Drug Ziltivekimab?
Ziltivekimab is an experimental anti-inflammatory medicine designed to target IL-6, a protein involved in immune and inflammatory responses.
The underlying strategy for Ziltivekimab is based on the idea that chronic inflammation contributes to cardiovascular disease and that reducing inflammation could lower the risk of serious heart problems.
However, the Novo Nordisk heart disease drug ziltivekimab has so far produced a disconnect between biological activity and clinical outcomes in previous trials.
The development challenge is not limited to Novo Nordisk. Recent setbacks involving other experimental cardiovascular medicines have also increased scrutiny of approaches that target specific biological pathways without demonstrating improved patient outcomes.
Recently, AstraZeneca has also announced that its late-stage clinical trial evaluating the Wainua drug for a rare heart condition failed to meet its primary goals.
What Happened in Novo Nordisk’s ZEUS Trial?
The latest development stems from the earlier ziltivekimab Phase 3 trial, ZEUS, which failed to meet its primary goal.
ZEUS evaluated ziltivekimab in more than 6,300 people with atherosclerotic cardiovascular disease, chronic kidney disease, and inflammation. The drug reduced inflammation biomarkers.
But ziltivekimab drug failed to reduce the risk of major cardiovascular complications, including cardiovascular death, non-fatal heart attack, and non-fatal stroke.
The decision to stop Novo Nordisk heart disease drug trials HERMES and ATHENA now adds further pressure to that strategy.
Is Novo Nordisk Still Testing Ziltivekimab Drug?
Despite the setbacks in Novo Nordisk heart disease drug trials HERMES and ATHENA, the company is continuing the ARTEMIS Phase 3 study.
ARTEMIS is testing ziltivekimab in patients following an acute heart attack, making it different from the two discontinued heart-failure studies. Novo expects to report results during the first half of 2027.
ARTEMIS is now particularly important in Novo Nordisk’s cardiovascular pipeline because it represents the remaining major late-stage opportunity for ziltivekimab.
What the Setback Means for Novo Nordisk?
The decision to stop the Novo Nordisk heart disease drug trials weakens one of the company’s most important attempts to diversify beyond obesity and diabetes.
Novo acquired ziltivekimab through its $725 million upfront acquisition of Massachusetts-based Corvidia Therapeutics in 2020.
Novo remains financially strong enough to absorb clinical failures, but the ziltivekimab results highlight the difficulty of building a second major growth engine, apart from its blockbuster weight-loss pipeline.
For now, attention will turn to ARTEMIS and its expected 2027 results. If that study also fails, the future of ziltivekimab and its role in Novo Nordisk’s cardiovascular strategy could become considerably more uncertain.
