UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
________________
FORM 6-K
________________
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
July 31, 2026
________________
NOVO NORDISK A/S
(Exact name
of Registrant as specified in its charter)
Novo Allé 1
DK- 2880, Bagsvaerd
Denmark
(Address of principal executive offices)
________________
Indicate by check mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F
Form 20-F ☒
Form 40-F ☐
Novo Nordisk provides update on the ZEUS phase
3 trial in people with ASCVD, CKD and inflammation
Bagsværd, Denmark, 31 July 2026 – Novo Nordisk today announced
headline results from the ZEUS cardiovascular outcomes phase 3 trial.
While ziltivekimab demonstrated target engagement and inhibition of the IL-6
pathway, as reflected by expected reductions in free IL-6 and high-sensitivity C-reactive protein (hsCRP) respectively, this did not translate
into major adverse cardiovascular events (MACE) risk reduction versus placebo in people with atherosclerotic cardiovascular disease (ASCVD),
chronic kidney disease (CKD) and inflammation (hazard ratio, 0.99; 95% confidence interval, 0.88 to 1.11)1.
ZEUS was a double-blind, placebo-controlled trial enrolling over 6,300 people
with ASCVD, CKD, and inflammation, as measured by hsCRP levels ≥2 mg/L. The trial evaluated once-monthly ziltivekimab 15 mg versus
placebo for reducing the risk of MACE, defined as cardiovascular (CV) death, non-fatal heart attack or non-fatal stroke.
“ZEUS was designed to test whether inhibition of the IL-6 pathway could
translate reductions in cardiovascular inflammation into fewer major cardiovascular events. Although ziltivekimab produced the expected
biological effect, this did not result in MACE benefits in this population,” said Martin Holst Lange, executive vice president,
chief scientific officer and head of Research and Development at Novo Nordisk. “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.”
Overall rates of adverse events (AEs) and serious AEs in people treated with ziltivekimab
were similar to those observed with placebo. Consistent with targeting IL-6 inhibition, a higher proportion of people treated with
ziltivekimab had serious infections compared to placebo. No difference in all-cause mortality was observed.
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The two additional ongoing cardiovascular outcomes trials investigating ziltivekimab
in people with heart failure (HERMES) and in people following an acute heart attack (ARTEMIS) are planned to continue and are anticipated
to read out in the first half of 2027.
The outcome of ZEUS will not impact Novo Nordisk’s previously communicated
adjusted operating profit outlook for 2026 but will result in a non-cash impairment charge in Q3 2026.
Full results of the ZEUS trial will be presented at an upcoming scientific meeting
in 2026.
About ziltivekimab
Ziltivekimab is an investigational, fully human monoclonal antibody that
targets the IL-6 ligand, a pro-inflammatory cytokine, to reduce cardiovascular inflammation and improve cardiovascular outcomes. It
is being developed by Novo Nordisk for conditions such as cardiovascular disease, acute myocardial infarction (AMI) and heart
failure with preserved ejection fraction (HFpEF).
About ZEUS
ZEUS – an event-driven cardiovascular outcomes trial investigating efficacy
and safety with once-monthly subcutaneous ziltivekimab 15 mg versus placebo on top of standard of care in people with atherosclerotic
cardiovascular disease (ASCVD), chronic kidney disease (CKD), and CV inflammation (hsCRP ≥ 2 mg/L).
Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered
in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering
scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about
68,800 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen
(Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Instagram,
X, LinkedIn and YouTube.
Publication of inside information pursuant to Market Abuse Regulation, Article 17.
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Contacts for further information
Novo Nordisk Media:
Ambre James-Brown
Liz Skrbkova (US)
+45 3079 9289
+1 609 917 0632
globalmedia@novonordisk.com
lzsk@novonordisk.com
Novo Nordisk Investors:
Michael Novod
Sina Meyer
+45 3075 6050
+45 3079 6656
nvno@novonordisk.com
azey@novonordisk.com
Ida Schaap Melvold
Christoffer Togo Solgaard-Tullin
+45 3077 5649
+45 3079 1471
idmg@novonordisk.com
cftu@novonordisk.com
Alex Bruce
Mads Berner Bruun
+45 3444 2613
+45 3075 2936
axeu@novonordisk.com
mbbz@novonordisk.com
Frederik Taylor Pitter (US)
+1 609 613 0568
fptr@novonordisk.com
Novo Nordisk A/S
Investor Relations
Novo Allé 1
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
www.novonordisk.com
CVR no: 24 25 67 90
Company
announcement No 45 / 2026
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf of the undersigned, thereunto duly authorized.
Date: July 31, 2026
NOVO NORDISK A/S
Maziar Mike Doustdar
Chief Executive Officer