UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
________________
FORM 6-K
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REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
May 13, 2020
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NOVO NORDISK A/S
(Exact name
of Registrant as specified in its charter)
Novo Allé
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 [X]
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Form 40-F [ ]
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Indicate by check mark whether the registrant by furnishing the information contained
in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange
Act of 1934.
If “Yes” is marked, indicate below the file number assigned to the registrant
in connection with Rule 12g-32(b):82-________
Semaglutide
2.4 mg demonstrates superior and sustained weight loss versus placebo and in addition a 17.4% weight loss after 68 weeks in STEP
4 trial
Bagsværd, Denmark,
13 May 2020 – Novo Nordisk today announced headline results from STEP 4, the first completed phase 3a trial in the STEP
programme. STEP 4 is a randomised, double-blind, multicentre, placebo-controlled, withdrawal trial exploring sustained weight management
with semaglutide vs placebo. The 68-week trial investigated the effect of once-weekly subcutaneous (sc) semaglutide 2.4 mg on body
weight in 902 people with obesity or overweight with comorbidities. After the 20-week run-in period, the 803 people reaching the
target dose of semaglutide 2.4 mg had reduced their mean body weight from 107.2 kg to 96.1 kg and were randomised to continued
treatment with either once-weekly sc semaglutide 2.4 mg or placebo for 48 weeks.
The trial achieved
its primary objective by demonstrating that in all people randomised1, continued
treatment with sc semaglutide 2.4 mg for 48 weeks (after the run-in period) resulted in an additional mean weight loss of 7.9%,
from a mean baseline body weight at randomisation of 96.1 kg, whereas people on placebo regained 6.9% of the body weight. The
treatment difference was statistically significant. People who received sc semaglutide 2.4 mg for 68 weeks (run-in period plus
48 weeks) achieved a total weight loss of 17.4%.
When evaluating
the effects of treatment if taken as intended2, people who continued treatment
with sc semaglutide 2.4 mg achieved an additional mean weight loss of 8.8% whereas people on placebo regained 6.5%. The treatment
difference was statistically significant. People who stayed on sc semaglutide 2.4 mg for 68 weeks achieved a weight loss of 18.2%.
In the trial, sc semaglutide 2.4 mg appeared
to have a safe and well-tolerated profile. The most common adverse events among people treated with sc semaglutide 2.4 mg
________________________
1
Based on the treatment policy estimand (primary statistical approach): treatment effect regardless of treatment adherence
or initiation of other anti-obesity therapies
2
Based on the trial product estimand (secondary statistical approach): treatment effect if all people adhered to treatment
and did not initiate other anti-obesity therapies
Page 2 of 3
were gastrointestinal
events. As seen previously with GLP-1 receptor agonists, most events were transient and mild or moderate in severity.
“Achieving sustained weight loss without
medical therapy is known to be very challenging. STEP 4 shows that people continuing treatment with semaglutide achieved a further
substantial weight loss while people switching to placebo, on the other hand, regained a significant amount of weight,” said
Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk and continues, “this highlights
that obesity is a chronic disease requiring sustained treatment, and we look forward to sharing additional results from the ongoing
STEP programme”.
About obesity
and sc semaglutide 2.4 mg for weight management
Obesity is a chronic disease that requires
long-term management. It is associated with many serious health consequences and decreased life expectancy. Obesity-related complications
are numerous and include type 2 diabetes, heart disease, obstructive sleep apnoea, chronic kidney disease, non-alcoholic fatty
liver disease and cancer.
Once-weekly sc semaglutide 2.4 mg is being
investigated by Novo Nordisk as a treatment for adults with obesity. Semaglutide is an analogue of the human glucagon- like peptide-1
(GLP-1) hormone. It induces weight loss by reducing hunger, increasing feelings of fullness and thereby helping people eat less
and reduce their calorie intake.
About the STEP
clinical programme
STEP (Semaglutide Treatment Effect in People
with obesity) is a phase 3 clinical development programme with once-weekly sc semaglutide 2.4 mg in obesity. The global clinical
phase 3a programme consists of 4 trials, having enrolled approximately 4,500 adults with overweight or obesity.
STEP 1 – a 68-week safety and efficacy trial
of sc semaglutide 2.4 mg versus placebo in 1,961 adults with obesity or overweight.
STEP 2 – a 68-week safety and efficacy
trial of sc semaglutide 2.4 mg versus placebo and once-weekly sc semaglutide 1.0 mg in 1,210 adults with type 2 diabetes and either
obesity or overweight.
STEP 3 - a 68-week safety and efficacy trial
of sc semaglutide 2.4 mg versus placebo in combination with intensive behavioural treatment in 611 adults with obesity or overweight.
STEP 4 –
a 68-week safety and efficacy trial of sc semaglutide 2.4 mg versus placebo in 803 adults with obesity or overweight who have
reached the target dose of 2.4 mg after a 20-week run-in.
Page
3 of 3
Novo
Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to
defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering
scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs
about 43,100 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,
Twitter, LinkedIn, YouTube.
Further information
Media:
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Mette Kruse Danielsen
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+45 3079 3883
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mkd@novonordisk.com
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Ken Inchausti (US)
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+1 609 240 9429
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kiau@novonordisk.com
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Investors:
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Daniel Muusmann Bohsen
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+45 3075 2175
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dabo@novonordisk.com
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Valdemar Borum Svarrer
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+45 3079 0301
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jvls@novonordisk.com
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Ann Søndermølle Rendbæk
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+45 3075 2253
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arnd@novonordisk.com
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Mark Joseph Root
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+45 3079 4211
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mjhr@novonordisk.com
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Kristoffer Due Berg (US)
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+1 609 235 2989
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krdb@novonordisk.com
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Novo Nordisk A/S
Investor Relations
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Novo Allé
2880 Bagsværd
Denmark
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Telephone:
+45 4444 8888
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Internet:
www.novonordisk.com
CVR no:
24 25 67 90
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Company announcement No 34 / 2020
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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: May 13, 2020
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NOVO NORDISK A/S
Lars Fruergaard Jørgensen
Chief Executive Officer
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