Semaglutide Injection Phase 2 Data Presented at ENDO Demonstrated Significant Weight Loss in Adults With Obesity

Chicago (ots/PRNewswire) - Oral session #12

Adults with obesity treated with semaglutide 0.4 mg administered
once-daily via subcutaneous injections lost up to 13.8% of their body
weight after 52 weeks in a phase 2 trial, significantly more than
those treated with placebo who lost 2.3% of their body weight.[1] An
oral presentation of data from this trial investigating the safety
and efficacy of semaglutide as a potential treatment for adults with
obesity took place at the Endocrine Society's annual meeting in
Chicago (ENDO).

The results were from a phase 2, 52-week double blind dose-ranging
study of once-daily semaglutide versus placebo and liraglutide 3 mg
as active control. All trial participants also received dietary and
physical exercise counselling.[1]

In the trial, 83% of people treated with semaglutide 0.4 mg lost
greater than or equal to 5% of their body weight (compared to 23%
with placebo and 66% with liraglutide 3 mg) and 65% lost greater than
or equal to 10% (compared to 10% with placebo and 34% with
liraglutide 3 mg).[1]

"In the US alone, more than 90 million adults have obesity. We need
to continue to research and develop new therapies to support those
living with this chronic disease," said Dr Patrick O'Neil of the
Medical University of South Carolina and lead investigator. "I am
encouraged by these results and look forward to seeing data from
upcoming phase 3 trials to better understand how semaglutide may play
a role in the treatment of obesity."

In the trial, the most common adverse events among people treated
with semaglutide were dose-related gastrointestinal events, as seen
previously with GLP-1 receptor agonists.[1]

"In line with our long-term commitment, we plan to start the STEP
phase 3 clinical development programme later this year to explore the
potential of once-weekly semaglutide as a treatment for people with
obesity," said Mads Krogsgaard Thomsen, executive vice president and
chief science officer of Novo Nordisk. "This will also include the
cardiovascular outcomes trial, SELECT, which will investigate the
impact of semaglutide on the incidence of major adverse
cardiovascular events compared to placebo in patients with
established cardiovascular disease and either overweight or obesity."

About the phase 2 clinical trial

The phase 2 trial was a 52-week multinational, double-blind,
dose-ranging study of semaglutide versus placebo and liraglutide 3 mg
as active control. The trial investigated the safety and efficacy of
once-daily semaglutide in 957 adult patients with obesity without
diabetes.

In the trial, adults treated with semaglutide received a once-daily
subcutaneous dose of 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg
(starting at 0.05 mg and escalating every 4 weeks to target dose).[1]
In the trial, the primary and secondary endpoints were analysed at 52
weeks. The primary endpoint was the change in body weight (%) from
baseline. The secondary endpoints included percentage of adults
achieving weight loss of >=5% and >=10%, change in body weight
(kg), HbA1c, and fasting plasma glucose (FPG) from baseline.

About semaglutide for obesity

Semaglutide is an analogue of the human glucagon-like peptide (GLP-1)
hormone, and induces weight loss by reducing hunger, increasing
feelings of fullness and helping people eat less.[2, 3]

Novo Nordisk plans to initiate a phase 3 clinical development
programme, STEP (Semaglutide Treatment Effect in People with
obesity), with once-weekly subcutaneous semaglutide in obesity in
2018. The global clinical programme is expected to enrol
approximately 4,500 people with obesity or overweight and all main
trials within the programme will have a duration of 68 weeks. In
addition to STEP, Novo Nordisk is also planning to initiate a
cardiovascular outcomes trial, SELECT (semaglutide effects on
cardiovascular outcomes in people with overweight or obesity), in
2018 with once-weekly subcutaneous semaglutide with an expected
enrolment of approximately 17,500 people.

Semaglutide is being investigated by Novo Nordisk as a potential
treatment for adults with obesity, and is not approved by the FDA,
EMA or any other regulatory authority for the management of obesity.

About obesity

Obesity is a disease[4, 5] that requires long-term management. It is
associated with many serious health consequences and decreased life
expectancy.[6, 7] Obesity-related complications include type 2
diabetes,[9] heart disease,[9] obstructive sleep apnoea,[8] chronic
kidney disease,[9] non-alcoholic fatty liver disease[10] and certain
types of cancer.[11] It is a complex and multi-factorial disease that
is influenced by physiological, psychological, environmental,
socio-economic and genetic factors.[12]

The global increase in the prevalence of obesity is a public health
issue that has severe cost implications to healthcare systems. In
2016, 13% of adults, or approximately 650 million adults, were living
with obesity worldwide.[13]

About Novo Nordisk

Novo Nordisk is a global healthcare company with 95 years of
innovation and leadership in diabetes care. This heritage has given
us experience and capabilities that also enable us to help people
defeat obesity, haemophilia, growth disorders and other serious
chronic diseases. Headquartered in Denmark, Novo Nordisk employs
approximately 42,100 people in 79 countries and markets its products
in more than 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
(http://www.novonordisk.com), Facebook
(http://www.facebook.com/novonordisk), Twitter
(http://www.twitter.com/novonordisk), LinkedIn
(http://www.linkedin.com/company/novo-nordisk), YouTube
(http://www.Youtube.com/novonordisk)

References

1. O'Neil PM, Birkenfeld AL, McGowan B, et al. A Randomized, Phase
II, Placebo- and Active-Controlled Dose-Ranging Study of Semaglutide
For Treatment of Obesity in Subjects Without Diabetes. Presented at
ENDO 2018 (OR12), 17-20 March, 2018. Chicago, USA.

2. Lau J, Bloch P, Schäffer L, et al. Discovery of the Once-Weekly
Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide. J Med Chem.
2015;58:7370-7380.

3. Blundell J, Finlayson G, Axelsen M, et al. Effects of once-weekly
semaglutide on appetite, energy intake, control of eating, food
preference and body weight in subjects with obesity. Diabetes Obes
Metab. 2017;19:1242-1251.

4. American Medical Association. A.M.A Adopts New Policies on Second
Day of Voting at Annual Meeting. Obesity as a Disease. Available at:
http://news.cision.com/american-medical-association/r/ama-adopts-new-
policies-on-second-day-of-voting-at-annual-meeting,c9430649. Last
accessed: March 2018.

5. WHO. Obesity: Preventing and managing the global epidemic.
Available at: http://www.who.int/iris/handle/10665/42330 Last
accessed: March 2018.

6. Guh DP, Zhang W, Bansback N, et al. The incidence of
co-morbidities related to obesity and overweight: a systematic review
and meta-analysis. BMC Public Health. 2009;9:1-20.

7. Peeters A, Barendregt JJ, Willekens F, et al. Obesity in adulthood
and its consequences for life expectancy: a life-table analysis.
Annals of Internal Medicine. 2003;138:24-32.

8. Gami AS, Caples SM, Somers VK. Obesity and obstructive sleep
apnea. Endocrinology and Metabolism Clinics of North America.
2003;32:869-894.

9. Yamagata K, Ishida K, Sairenchi T, et al. Risk factors for chronic
kidney disease in a community-based population: a 10-year follow-up
study. Kidney Int. 2007;71:159-166.

10. Vernon G, Baranova A, Younossi ZM. Systematic review: the
epidemiology and natural history of non-alcoholic fatty liver disease
and non-alcoholic steatohepatitis in adults. Aliment Pharmacol Ther.
2011;34:274-285.

11. Whitlock G, Lewington S, Sherliker P, et al. Body-mass index and
cause-specific mortality in 900 000 adults: collaborative analyses of
57 prospective studies. Lancet. 2009;373:1083-1096.

12. Wright SM, Aronne LJ. Causes of obesity. Abdominal Imaging.
2012;37:730-732.

13. World Health Organization. Obesity and Overweight Factsheet no.
311. Available at:
http://www.who.int/mediacentre/factsheets/fs311/en/. Last accessed:
March 2018.

Further information

Media:        

Katrine Sperling, +45-4442-6718,
[email protected]

Liz Skrbkova (US), +1-609-917-0632, [email protected]

Ken Inchausti (US), +1-609-786-8316, [email protected]


Investors:        

Peter Hugreffe Ankersen, +45-3075-9085,
[email protected]

Anders Mikkelsen, +45-3079-4461, [email protected]

Christina Kjær, +45-3079-3009, [email protected]

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