Novo Nordisk halts the HERMES and ATHENA ziltivekimab heart failure trials for futility

Novo Nordisk has stopped two late-stage trials of ziltivekimab, an antibody that blocks the inflammatory signal interleukin-6, after an independent data monitoring committee concluded the studies were unlikely to succeed ^[1][2]. The company notified trial investigators on Friday, September 4, 2026 ^[1].

The two halted studies, HERMES and ATHENA, enrolled people with heart failure. HERMES was designed to measure the time to a first cardiovascular death, heart failure hospitalization or urgent heart failure visit, while ATHENA looked at quality-of-life measures in a similar population. Novo Nordisk stopped both for futility — meaning the monitoring committee judged that continuing was unlikely to produce a positive result — rather than for a specific safety problem reported in the coverage so far ^[1][2].

The decision follows the failure of ZEUS, a larger outcomes trial of the same drug, which was reported on July 31, 2026 ^[1]. In ZEUS, ziltivekimab lowered markers of inflammation but did not reduce the risk of major clinical complications, including deaths and heart attacks ^[1]. That combination — clear effects on a blood test, no effect on the events patients care about — is the core disappointment here, and it is why STAT described the new halts as "another blow" for the strategy of treating heart disease by tamping down inflammation ^[1].

Ziltivekimab is not a GLP-1 drug. It is a separate Novo Nordisk program aimed at cardiovascular risk that persists even when cholesterol and blood pressure are controlled. With HERMES and ATHENA stopped and ZEUS negative, ARTEMIS — a Phase 3 study in patients after a heart attack — is the last remaining large trial of the drug, with results expected in the first half of 2027. Novo Nordisk has not said publicly, in the coverage available, whether ARTEMIS will continue unchanged or whether the company will make any decision about the program before those data arrive.

The fallout extends beyond one company. STAT has since reported that recent cardiovascular drug failures at Novartis and Novo Nordisk will likely "pop a hole in the balloon" of the field ^[1].

Why it matters for patients

For people taking or considering semaglutide (Ozempic, Wegovy, Rybelsus) or tirzepatide (Mounjaro, Zepbound), nothing about these drugs changes because of this news. Ziltivekimab is an injectable antibody in testing, not an approved medicine, and it was not being studied as a companion to or replacement for GLP-1 treatment in the trials described here ^[1][2].

What the news does show is how a drug company's pipeline can narrow quickly. Novo Nordisk had positioned ziltivekimab as a way to broaden its cardiovascular business beyond metabolic drugs. Three Phase 3 trials have now ended without success, and only ARTEMIS is left ^[1][2].

It is also a reminder of a recurring pattern in heart research: a drug can move a lab number, such as an inflammation marker, without lowering the chance of a heart attack, a hospitalization or death ^[1]. That distinction matters when weighing any treatment that is promoted on the basis of biomarkers rather than hard outcomes.

Patients enrolled in HERMES or ATHENA will be contacted by their study sites about next steps; the public reports do not describe the wind-down process, and no results from either trial have been released ^[1][2].

What happens next

• July 31, 2026: ZEUS results reported; ziltivekimab lowered inflammation markers but did not cut major cardiovascular events ^[1].
• September 4, 2026: Novo Nordisk informs investigators that HERMES and ATHENA are ending early for futility ^[1].
• First half of 2027: ARTEMIS, in post-heart-attack patients, is expected to read out — the last Phase 3 test of the drug.

Whether Novo Nordisk presents detailed HERMES and ATHENA data at a medical meeting, and when, is not yet known from the available reporting ^[1][2].