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

Food and Healthcare Press Releases Tuesday March 20, 2018 08:22
CHICAGO--20 Mar--PRNewswire/InfoQuest
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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 , Facebook , Twitter , LinkedIn , YouTube

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, Scha?ffer 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

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