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:
- STEP 1: Efficacy and safety of once-weekly subcutaneous
semaglutide 2.4 mg in adults with overweight or obesity (Abstract
6923)
- STEP 1 Exploratory Analysis: Impact of semaglutide 2.4 mg
once weekly on body composition in adults with overweight or
obesity (Abstract 7180)
- STEP 2: Efficacy and safety of semaglutide 2.4 mg once
weekly in adults with overweight or obesity and type 2 diabetes
(Abstract 7068)
- STEP 4: Weight maintenance with once-weekly semaglutide 2.4
mg in adults with overweight or obesity reaching maintenance dose
(Oral presentation, session ORO2)
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, Instagram 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.
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SOURCE Novo Nordisk