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

PR72739

CHICAGO, March 19, 2018 /PRNewswire=KYODO JBN/ --

     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 greater than or equal

to5% and greater than or equal to10%, 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, krsp@novonordisk.com

    Liz Skrbkova (US), +1-609-917-0632, lzsk@novonordisk.com

    Ken Inchausti (US), +1-609-786-8316, kiau@novonordisk.com

    Investors:

    Peter Hugreffe Ankersen, +45-3075-9085, phak@novonordisk.com

    Anders Mikkelsen, +45-3079-4461, armk@novonordisk.com

    Christina Kjaer, +45-3079-3009, cnje@novonordisk.com

SOURCE: Novo Nordisk