NOVO NORDISK
Mon, 15 Mar 2021 09:23:00 -0400
Mon, 15 Mar 2021 09:23:00 -0400
PLAINSBORO, N.J., March 15, 2021 /PRNewswire/ -- Novo Nordisk today announced that results from three trials from the pivotal STEP (Semaglutide Treatment Effect in People with obesity) phase 3 clinical development program with investigational once-weekly subcutaneous semaglutide 2.4 mg will be shared at the virtual ENDO Annual Meeting on March 20-23.
STEP is one of the largest clinical trial programs for the
management of obesity, consisting of four global trials involving
approximately 4,500 adults with excess weight or obesity. The program
provides a detailed snapshot of weight management and lifestyle
intervention in participants treated with semaglutide 2.4
mg.1
"Obesity is a disease that has a direct impact on overall health and may be linked to at least 60 other serious health conditions," said Anne Phillips, senior vice president, Clinical, Medical and Regulatory Affairs of Novo Nordisk. "Through the comprehensive approach of the core STEP trials, we believe the findings have the potential to help people lose weight and impact medical management for those living with obesity. The strength of the data enabled us to file for FDA approval in December, and we anticipate their decision in the coming months."
The following will be presented at ENDO:
In addition to evaluating the effect of weight loss and management,
the confirmatory secondary analyses investigated waist circumference
and certain cardiometabolic risk factors.2,3,4,5
Data will be available online from March 20-23 as part of the virtual ENDO annual meeting. Results from the STEP 4 trial will be presented live from 2:00-3:00 PM on March 23.
About semaglutide 2.4 mg for weight management
Once-weekly sc semaglutide 2.4 mg is being investigated by Novo
Nordisk as a potential treatment option for obesity. Semaglutide is an
analogue of the human glucagon-like peptide-1 (GLP-1)
hormone.6,7
About the STEP clinical trial program
STEP
(Semaglutide Treatment Effect in People
with obesity) is a phase 3 clinical development program with
once-weekly sc semaglutide 2.4 mg in obesity. The global phase 3a
program consists of four trials and has enrolled approximately 4,500
adults with overweight or obesity.1
About obesity
Obesity is a chronic, progressive and misunderstood disease that
requires long-term medical management.8,9 One key
misunderstanding is that this is a disease of willpower, when in fact
there is underlying biology that prevents people from losing weight
and keeping it off.10 Obesity is influenced by a variety of
factors, including genetics, appetite signals, behavior and the
environment.10 It is a gateway disease and is associated
with at least 60 other health conditions.11 The current
COVID-19 pandemic has highlighted that obesity also increases the risk
for severe illness and hospitalization due to COVID-19.12,13
The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems. In the United States, more than 42% of adults live with obesity.14
About Novo Nordisk
Novo Nordisk is a global healthcare company that's been making
innovative medicines to help people 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 lasting
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 six states, Novo Nordisk
employs nearly 6,000 people throughout the country. For more
information, visit
novonordisk.us
,
Facebook
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and
Twitter
.
References
1 Kushner RF, Calanna S, Davies M, et al. Semaglutide 2.4
mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to
5. Obesity. 2020; 28:1050-1061.
2 Wilding JP, Batterham R, et al. Once-weekly semaglutide
in adults with overweight or obesity. New England Journal of
Medicine. February 10, 2021.
3 Wilding JP, Batterham R, et al. Impact of semaglutide on
body composition in adults with overweight or obesity: Exploratory
analysis of the STEP 1 study. Presented at ENDO Annual Meeting. March 20-23, 2021.
4 Davies M, Færch L, et al. Semaglutide 2·4 mg once a week
in adults with overweight or obesity, and type 2 diabetes Presented at
ENDO Annual Meeting. March 20-23, 2021.
5 Domenica R, Abrahamsson N, et al. Weight loss maintenance
with once-weekly semaglutide 2.4 mg in adults with overweight or
obesity reaching maintenance dose. Presented at ENDO Annual Meeting.
March 20-23, 2021
6 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.
7 Lau J, Bloch P, Schaffer L, et al. Discovery of the
Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide. J
Med Chem. 2015; 58:7370-7380.
8 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: February 2021.
9 Bray GA, Kim KK, Wilding JPH. World Obesity Federation.
Obesity: a chronic relapsing progressive disease process. A position
statement of the World Obesity Federation. ObesRev.
2017;18(7):715-723. doi:10.1111/obr.12551.
10 Wright SM, Aronne LJ. Causes of obesity. Abdom
Imaging. 2012;37(5):730-732.
11 Bays HE, McCarthy W, Christensen S, et al. Obesity
Algorithm, presented by the Obesity Medicine Association. Available
at: https://obesitymedicine.org/obesity-algorithm/.
Last Accessed: February 2021.
12 Finer N, Garnett SP and Bruun JM. COVID-19 and obesity.
Clin Obes. 2020; 10:e12365.
13 Ryan DH, Ravussin E and Heymsfield S. COVID 19 and the
Patient with Obesity - The Editors Speak Out. Obesity
(Silver Spring). 2020; 28:847.
14 Adult Obesity Facts. Centers for Disease Control and
Prevention. https://www.cdc.gov/obesity/data/adult.html.
Updated June 29, 2020. Last accessed:
February 2021.
SOURCE Novo Nordisk