Ziltivekimab Trial Setback
Novo Nordisk halts late-stage ziltivekimab heart trials following independent committee review.
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Key Points
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HERMES and ATHENA were designed to test whether ziltivekimab could improve outcomes in heart-failure patients with preserved or mildly reduced ejection fraction, including time to cardiovascular death, heart-failure hospitalization, urgent heart-failure visits, and quality of life.
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The failed ZEUS trial enrolled patients with atherosclerotic cardiovascular disease complicated by chronic kidney disease and inflammation, a different population from the heart-failure patients studied in HERMES and ATHENA.
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Novo Nordisk acquired ziltivekimab through its $725 million takeover of AstraZeneca spin-out Corvidia Therapeutics in 2020.
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The company’s remaining ARTEMIS study is testing ziltivekimab as an acute treatment after myocardial infarction, with results expected in the first half of 2027.
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Novo Nordisk informed investigators of the decision to halt HERMES and ATHENA on Friday, according to STAT News.
Novo Nordisk has halted two late-stage trials of ziltivekimab, an experimental heart drug, after a data-monitoring committee determined they were unlikely to succeed. STAT News reported Friday that the company stopped the HERMES and ATHENA trials, which were testing whether the drug could improve outcomes in heart-failure patients. This decision follows the drug's failure in the earlier ZEUS trial, where it reduced inflammation but did not lower heart attacks, strokes, or deaths.
The setback adds pressure on Novo Nordisk to strengthen its pipeline beyond diabetes and obesity treatments, where the company has found major success. The company acquired ziltivekimab in 2020 when it bought AstraZeneca's spin-out Corvidia Therapeutics for $725 million. One remaining trial, called ARTEMIS, is still testing the drug in patients recovering from heart attacks, with results expected in early 2027.
ZEUS Failure Signals Trouble for Anti-Inflammatory Heart Drugs
Ziltivekimab targets IL-6, a protein tied to inflammation in the body. In the ZEUS trial, the drug successfully lowered inflammation markers in patients with heart disease and chronic kidney disease. However, it failed to reduce major cardiovascular problems. Biospace reported that this outcome suggests IL-6 may be an 'invalid target' for treating heart disease broadly.
The HERMES and ATHENA trials were designed to test the drug in different patients — those with heart failure with preserved or mildly reduced ejection fraction. A data-monitoring committee concluded these trials had a low likelihood of succeeding where ZEUS had failed. Medical Daily noted the committee's assessment that the drug was unlikely to achieve different results in this patient population.
Novo Nordisk's Shrinking Heart Disease Pipeline
The company now has only one ziltivekimab study remaining: ARTEMIS, which tests the drug as an acute treatment given immediately after a heart attack. Seeking Alpha reported that results from this trial are expected in the first half of 2027. Success here could salvage the program, but the pattern of failures raises doubts about the drug's overall potential.
Novo Nordisk paid $725 million for Corvidia and ziltivekimab in 2020, betting the drug would become a major revenue driver. The halting of HERMES and ATHENA represents a major loss for that acquisition. Markets Business Insider noted the company has faced fresh setbacks as it attempts to diversify beyond its blockbuster diabetes and obesity medications.
What the Halts Mean for Novo Nordisk's Strategy
Novo Nordisk has built massive profits from GLP-1 drugs like Ozempic and Wegovy, which treat diabetes and obesity. The company has invested heavily in heart disease research to create a second pillar of growth. The failure of ziltivekimab undermines that strategy and forces the company to look elsewhere for new products.
The setbacks raise questions about whether inflammation truly drives cardiovascular disease in the ways scientists believed. Biospace reported that dimming prospects for the entire IL-6 inhibitor class suggest the field may need to rethink its approach. Novo Nordisk will need stronger pipeline candidates to maintain investor confidence as diabetes and obesity competition intensifies.
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