Bagsværd, Denmark, 26 June 2024 - Novo Nordisk today announced that the CLARION-
CKD phase 3 trial failed to meet its primary endpoint and that it will recognise
an impairment loss of around DKK 5.7 billion related to the intangible asset
ocedurenone in the second quarter of 2024.
Novo Nordisk acquired ocedurenone from KBP Biosciences PTE., Ltd. in 2023. The
phase 3 lead indication trial CLARION-CKD, which investigated ocedurenone in
patients with uncontrolled hypertension and advanced chronic kidney disease, was
conducted by KBP Biosciences.
The trial design included a prespecified interim analysis after all trial
participants had completed 12 weeks of treatment. Based on the interim analysis,
an independent data monitoring committee concluded that the trial met the
prespecified futility criteria - meaning that the trial did not meet its primary
endpoint of change in systolic blood pressure from baseline to week 12. As a
result, Novo Nordisk has decided to stop the CLARION-CKD trial.
Consequently, Novo Nordisk will recognise an impairment loss of around DKK 5.7
billion. This corresponds to an estimated negative impact of around 6 percentage
points on operating profit growth at CER in 2024 compared to the operating
profit outlook communicated in the financial report for the period 1 January
2024 to 31 March 2024 (Company Announcement No 35/2024).
Novo Nordisk's disclosure of the financial results for the first six months of
2024 and financial outlook for 2024 will be published on 7 August 2024.
Further development of ocedurenone in other indications is now being evaluated.
About ocedurenone
Ocedurenone is a third-generation, non-steroidal, mineralocorticoid receptor
antagonist (MRA) with a unique pharmacokinetic (PK) profile characterised by a
long half-life and high mineralocorticoid receptor (MR) affinity.
About CLARION-CKD
CLARION-CKD was a multicenter, double-blind, placebo-controlled, randomised
phase 3 study of ocedurenone for uncontrolled hypertension in patients with
advanced chronic kidney disease (CKD). CLARION-CKD follows the same inclusion
criteria as the phase 2b BLOCK-CKD study, which achieved its primary endpoint
with clinical and statistical significance. For the CLARION-CKD trial, more than
600 patients were randomised at more than 150 sites.
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 66,000 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,
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(http://www.facebook.com/novonordisk)
Contacts for further information
Media:

 Ambre James-Brown                      Liz Skrbkova (US)
 +45 3079 9289                          +1 609 917 0632
 abmo@novonordisk.com                   lzsk@novonordisk.com
 (mailto:abmo@novonordisk.com)          (mailto:lzsk@novonordisk.com)

Investors:

 Jacob Martin Wiborg Rode               David Heiberg Landsted
 +45 3075 5956                          +45 3077 6915
 jrde@novonordisk.com                   dhel@novonordisk.com
 (mailto:jrde@novonordisk.com)          (mailto:dhel@novonordisk.com)
 Sina Meyer                             Mark Joseph Root (US)
 +45 3079 6656                          +1 848 213 3219
 azey@novonordisk.com                   mjhr@novonordisk.com
 (mailto:azey@novonordisk.com)          (mailto:mjhr@novonordisk.com)
 Ida Melvold Gjøsund                    Frederik Taylor Pitter
 +45 3077 5649 idmg@novonordisk.com     +45 3075 8259
 (mailto:idmg@novonordisk.com)          fptr@novonordisk.com
                                        (mailto:fptr@novonordisk.com)

Company announcement No 49 / 2024
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