CHICAGO, March 19, 2018 /PRNewswire/ -- 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 counseling.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 program 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 analyzed 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 program, STEP (Semaglutide Treatment Effect in People with obesity), with once-weekly subcutaneous semaglutide in obesity in 2018. The global clinical program is expected to enroll approximately 4,500 people with obesity or overweight and all main trials within the program 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.
Obesity is a chronic disease requiring long-term management.4,5 Complex and multifactorial in nature, obesity is influenced by genetic, physiological, environmental and psychological factors and is associated with many serious health consequences and decreased life expectancy.6-8
The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems.9,10 In the United States, 38% of adults, or more than 90 million adults, live with obesity.11Despite the high prevalence of obesity, many people with obesity lack support in their efforts to lose weight and the disease remains substantially underdiagnosed and underreported.12
About Novo NordiskNovo Nordisk, a global healthcare company, has been committed to discovering and developing innovative medicines to help people living with diabetes lead longer, healthier lives for 95 years. This heritage has given us experience and capabilities that also enable us to help people defeat other serious diseases including obesity, hemophilia and growth disorders. We remain steadfast in our conviction that the formula for success is to stay focused, think long term and do business in a financially, socially and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in four states, Novo Nordisk employs nearly 6,000 people throughout the country. For more information, visit novonordisk.us, Facebook and Twitter.
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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.
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
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
American Medical Association House of Delegates. Recognition of obesity as a disease. Resolution 420 (A 13). https://www.npr.org/documents/2013/jun/ama-resolution-obesity.pdf. Received May 15, 2013. Last accessed: February 2018.
WHO. Obesity: Preventing and managing the global epidemic. Available at: http://www.who.int/iris/handle/10665/42330. Last accessed: February 2018.
Wright SM, Aronne LJ. Causes of obesity. Abdominal Imaging. 2012;37:730–732.
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.
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.
World Health Organization. Fact sheet no. 311: obesity and overweight. http://www.who.int/mediacentre/factsheets/fs311/en/. Updated June 2016. Last accessed: February 2018
Cawley J, Meyerhoefer C. The medical care costs of obesity: an instrumental variables approach. J Health Economics. 2012;31(1):219-230.
Obesity and overweight. Centers for Disease Control and Prevention website. https://www.cdc.gov/nchs/fastats/obesity-overweight.htm. Updated May 3, 2017. Last accessed: February 2018
Crawford AG, Cote C, Couto J, et al. Prevalence of Obesity, Type II Diabetes Mellitus, Hyperlipidemia, and Hypertension in the United States: Findings from the GE Centricity Electronic Medical Record Database. Popul Health Manag. 2010;13:151–161.
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