Novo Nordisk has terminated two Phase III trials of the IL‑6 antibody ziltivekimab — HERMES (NCT05636176) and ATHENA (NCT06200207) — after an independent data monitoring committee concluded they were unlikely to meet their endpoints. The decision follows the July failure of the ZEUS trial (NCT05021835), which did not show a reduction in MACE. Novo will continue the Phase III ARTEMIS trial testing ziltivekimab as an acute post‑heart‑attack treatment, with results expected in H1 2027. All patients in the halted studies will be followed through their scheduled three‑month visits.
Novo Nordisk Halts Two Phase III Trials of Ziltivekimab After DMC Review — ARTEMIS Continues
The HERMES and ATHENA trials will stop due to a data monitoring committee's recommendation. Credit: Below the Sky / Shutterstock.com.
Novo Nordisk has stopped two Phase III trials of the IL‑6–targeting antibody ziltivekimab after an independent data monitoring committee (DMC) concluded the studies were unlikely to meet their planned goals.
In a statement to Clinical Trials Arena, the Danish drugmaker said investigators were informed on 4 September that the HERMES (NCT05636176) and ATHENA (NCT06200207) trials would be terminated early. The developments were first reported by Endpoints on 7 September.
Why the Trials Were Halted
According to Novo Nordisk, the DMC reviewed the accumulated data and recommended stopping both trials because it was unlikely they would produce different results from the Phase III ZEUS trial, which missed its primary endpoint in July. ZEUS (NCT05021835) found that ziltivekimab did not reduce the risk of major adverse cardiovascular events (MACE) in patients with atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), and systemic inflammation.
What HERMES and ATHENA Were Testing
HERMES aimed to assess ziltivekimab’s effect on time to first heart‑failure‑related event, including cardiovascular death and heart‑failure‑related hospitalisations or urgent visits. ATHENA evaluated a broader set of heart‑failure outcomes, including measures such as patient quality of life.
Next Steps and Ongoing Programs
Novo Nordisk said it will continue to follow all patients already enrolled in HERMES and ATHENA through their planned three‑month follow‑up visits to collect remaining safety and outcome data.
Importantly for the ziltivekimab programme, Novo will proceed with the Phase III ARTEMIS trial, which is testing the antibody as an acute treatment after a heart attack. A data readout from ARTEMIS is expected in the first half of 2027, and the company says that trial’s timeline remains unchanged.
Background
Zmiltivekimab is a once‑monthly subcutaneous antibody that targets interleukin‑6 (IL‑6)–mediated inflammation. Novo Nordisk acquired global rights to the drug when it purchased Corvidia Therapeutics in 2020, paying $725 million upfront.
Novo Nordisk: All patients will be followed through to their three‑months follow‑up visit as already planned.
Although the halt of HERMES and ATHENA represents a setback for ziltivekimab’s development in chronic heart‑failure and atherosclerotic disease, the ARTEMIS study offers an alternative pathway to demonstrate benefit in the acute post‑myocardial‑infarction setting. Observers will be watching the ARTEMIS readout expected in H1 2027 for further direction on the drug’s prospects.
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