Semaglutide in people with obesity: boosts wellbeing and ability to perform daily physical activities
PR89489
BAGSVAERD, Denmark, May 13, 2021 /PRNewswire=KYODO JBN/ --
Novo Nordisk today announced new results from the STEP phase 3a clinical trial
programme, demonstrating potential benefits beyond weight loss for people with
obesity being treated with semaglutide 2.4 mg. The trial showed that treatment
with once-weekly semaglutide 2.4 mg led to significant improvements in physical
functioning, such as climbing stairs and tying your shoes, and beneficial
effects on weight related and health related quality of life scores (HRQoL)
compared to placebo.* Following the 68-week treatment period, more than half of
participants had improved quality of life scores, indicating better physical
function and improved psychological wellbeing.[1] The results from the STEP 1
trial will be presented today at the virtual European Congress on Obesity (ECO)
2021 Annual Meeting.
"Weight management is much more than achieving weight loss. We should also aim
to improve the impairments that accompany elevated weight such as decreased
physical functioning," said Dr Sean Wharton of the Wharton Medical Clinic,
Toronto, Canada and an investigator of this study. "It is encouraging to see
that the significant weight loss achieved in STEP 1 had such a positive impact
on people's wellbeing and their ability to perform daily physical activities,
such as taking walks and going about their daily routines."
Obesity is becoming one of the most important global health concerns, with more
than 650 million people living with obesity worldwide.[2] The risk factors of
obesity and overweight, such as increased risk of type 2 diabetes and
cardiovascular disease, are well-documented. However, often obesity has a
significant negative impact on people's wellbeing affecting their physical and
psychological health and limiting their daily activities.[3]
"I am really proud of these results. Obesity is not only about the weight
itself; living with this chronic disease affects all aspects of a person's life
such as not being able to climb stairs or move around as part of one's daily
routines," said Martin Holst Lange, executive vice president, Development at
Novo Nordisk. "This has implications both for physical and mental health. This
study shows that treatment with semaglutide 2.4 mg improves mental and physical
wellbeing. It holds real potential to improve the lives of people living with
obesity."
Data Details
In the phase 3a STEP 1 trial, treatment with once-weekly semaglutide 2.4 mg
over a 68-week period was associated with greater improvements for all weight-
and health-related quality of life scores(A) in people with obesity or
overweight, compared to placebo. People on semaglutide 2.4 mg had an improved
wellbeing such as feeling more energetic and more self-confident, with 43.8%
achieving a clinically meaningful improvement in total weight-related quality
of life score(B) at week 68. In addition, more than half of people (51.2%)
treated with semaglutide 2.4 mg had an increased weight-related physical
function score indicating improvements in the ability to perform daily physical
activities such as tying their shoe and walking to the shops. These
improvements occurred simultaneously with the significant weight loss of 14.9%
(16.9% with the trial product estimand) observed with semaglutide 2.4 mg over
more than a year.[4]
The safety profile of semaglutide 2.4 mg is in line with observations seen
previously with glucagon-like peptide-1 (GLP-1) receptor agonists. Semaglutide
2.4 mg is generally well-tolerated, and the most common adverse events among
people treated with semaglutide 2.4 mg were gastrointestinal events.[1,5]
About STEP 1 and the STEP clinical trial programme
STEP 1 was a 68-week phase 3a randomised, double-blind, multicentre,
placebo-controlled trial that investigated the percentage change in body weight
and the number of people achieving 5% or more weight reduction with
subcutaneous semaglutide 2.4 mg versus placebo, in conjunction with lifestyle
intervention. The trial was designed to assess the effect of once-weekly
semaglutide 2.4 mg plus lifestyle intervention on sustained, clinically
relevant reduction in body weight in adults with a body mass index of greater
than or equal to 30 or greater than or equal to 27 in people with greater than
or equal to 1 weight-related coexisting condition. Participants were randomly
assigned (in a 2:1 ratio) to 68 weeks of treatment with once-weekly
subcutaneous semaglutide (at a dose of 2.4 mg) or placebo, plus lifestyle
intervention (counselling and a reduced-calorie diet together with 150 minutes
per week of physical activity).[1,5]
STEP (Semaglutide Treatment Effect in People with obesity) is a phase 3
clinical development programme with once-weekly subcutaneous semaglutide 2.4 mg
in obesity. The global clinical phase 3a programme consists of four trials and
has enrolled approximately 4,500 adults with overweight or obesity.[6] In the
STEP trials, the primary estimand (treatment policy estimand) assessed effects
regardless of treatment adherence or initiation of other anti-obesity
therapies. The secondary estimand (trial product estimand) assessed effects if
all people adhered to treatment and did not initiate other anti-obesity
therapies.
In the phase 3a STEP 1 trial, people on semaglutide 2.4 mg experienced
significant improvements in weight-related quality of life, with 43.8%
achieving clinically meaningful improvement in total weight-related quality of
life score(B) of greater than or equal to 16.6 points at week 68. In addition,
51.2% of people treated with semaglutide 2.4 mg achieved clinically meaningful
improvement in weight-related physical function score (greater than or equal to
14.6 points) compared to 32.9% with placebo. Changes in health-related quality
of life scores(C), such as physical functioning and social functioning, were
higher and favoured semaglutide versus placebo.[5] Similarly, 40% of
participants achieved clinical meaningful improvement in health-related
physical functioning score (greater than or equal to 3.7 points), compared to
27% with placebo.[1,5] These improvements were observed using patient-reported
outcome methods commonly used in clinical trials for people with obesity.
About subcutaneous semaglutide 2.4 mg for weight management
Once-weekly semaglutide 2.4 mg is under investigation for chronic weight
management and not yet approved for people with obesity. It is currently under
regulatory review in several countries, including the U.S. Food and Drug
Administration (FDA) and the European Medicines Agency (EMA).
Semaglutide is an analogue of the human glucagon-like peptide-1 (GLP-1)
hormone, with 94% similarity to the native human GLP-1 molecule.[7,8] It
induces weight loss by reducing hunger, increasing feeling of fullness and
thereby helping people eat less and reduce their food cravings.[7]
About obesity
Obesity is a chronic disease that requires long-term management.[9,10] It is
associated with many serious health complications and decreased life
expectancy.[11,12] Obesity-related complications are numerous and include type
2 diabetes,[10] heart disease,[10] obstructive sleep apnoea,[13] non-alcoholic
fatty liver disease[14] and certain types of cancer.[15] The current COVID-19
pandemic has highlighted that obesity also increases the risk for severe
illness and hospitalisation due to COVID-19.[16,17]
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.[18]
About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and
headquartered in Denmark. Our purpose is to drive change to defeat diabetes and
other serious chronic diseases such as obesity and rare blood and endocrine
disorders. We do so by pioneering scientific breakthroughs, expanding access to
our medicines and working to prevent and ultimately cure disease. Novo Nordisk
employs about 45,800 people in 80 countries and markets its products in around
170 countries. 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 ).
*The STEP trial participants were adults with a body-mass index of 30 or
greater (Obesity) (greater than or equal to 27 in persons with greater than or
equal to 1 weight-related coexisting condition (overweight).
A. Weight and health related quality of life improvements were assessed using
patient reported outcomes tools including Impact of Weight on Quality of
Life-Lite Clinical Trials Version (IWQOL-Lite-CT) and Short Form 36 (SF-36)
questionnaires
B. IWQOL-Lite-CT is a questionnaire assessing the effect of weight on various
areas of life such as physical function, self-esteem, public distress, sexual
life and work; scores range from 0 to 100, with higher scores indicating better
levels of functioning
C. SF-36 is a 36-item questionnaire evaluating health-related quality of life
including physical functioning, bodily pain, role limitations due to physical
health problems, emotional well-being, and social functioning; scores range
from 0 to 100, with higher scores indicating favourable health status.
References:
1. Wharton S, Bjorner JB, Kushner RF, et al. Semaglutide 2.4 mg Once Weekly
Improves Patient-Reported Outcome Measures of Physical Functioning in Adults
with Overweight or Obesity in the STEP 1 Trial. Presented at ECO 2021, May
10-13.
2. World Health Organization. Obesity and Overweight Factsheet no. 311.
Available at: http://www.who.int/mediacentre/factsheets/fs311/en/. Last
accessed: May 2021.
3. Phelan S, Burgess DJ, Yeazel MW, et al. Impact of weight bias and stigma on
quality of care and outcomes for patients with obesity. Obesity Reviews. 2015;
16:319-326.
4. Wilding JPH, Batterham RL, Calanna S, et al. Once-Weekly Semaglutide in
Adults with Overweight or Obesity. N Engl J Med. 2021; 384:989.
5. Rubino DM, Bjorner JB, Kushner RF, et al. Beneficial Effect of Semaglutide
2.4 mg Once Weekly on Patient-Reported Outcome Measures of Weight-Related and
Health-Related Quality of Life in Adults With Overweight or Obesity in the STEP
1 Trial. Presented at ECO 2021, 10-13 May.
6. Kushner RF, Calanna S, Davies M, et al. Semaglutide 2.4 mg for the Treatment
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7. Blundell J, Finlayson G, Axelsen M, et al. Effects of once-weekly
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9. Wadden TA, et al. Intensive Behavioral Therapy for Obesity Combined with
Liraglutide 3.0 mg: A Randomized Controlled Trial. Obesity 2019;21:75–86.
10. WHO. Obesity: Preventing and managing the global epidemic. Available at:
http://www.who.int/iris/handle/10665/42330. Last accessed: May 2021.
11. Peeters A, Barendregt JJ, Willekens F, et al. Obesity in adulthood and its
consequences for life expectancy: a life-table analysis. Ann Intern Med. 2003;
138:24-32.
12. 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
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Endocrinology and Metabolism Clinics of North America. 2003; 32:869-894.
14. Vernon G, Baranova A and Younossi ZM. Systematic review: the epidemiology
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steatohepatitis in adults. Aliment Pharmacol Ther. 2011; 34:274-285.
15. 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.
16. Finer N, Garnett SP and Bruun JM. COVID-19 and obesity. Clin Obes. 2020;
10:e12365.
17. Ryan DH, Ravussin E and Heymsfield S. COVID 19 and the Patient with Obesity
- The Editors Speak Out. Obesity (Silver Spring). 2020; 28:847.
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SOURCE Novo Nordisk
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