Semaglutide in people with obesity: boosts wellbeing and ability to perform daily physical activities

Novo Nordisk

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

of Obesity: Key Elements of the STEP Trials 1 to 5. Obesity. 2020;

28:1050-1061.

7. 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.

8. 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.

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

Health. 2009; 9:88.

13. Gami AS, Caples SM and Somers VK. Obesity and obstructive sleep apnea.

Endocrinology and Metabolism Clinics of North America. 2003; 32:869-894.

14. Vernon G, Baranova A and 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.

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.

18. Durrer Schutz D, Busetto L, Dicker D, et al. European Practical and

Patient-Centred Guidelines for Adult Obesity Management in Primary Care. Obes

Facts. 2019; 12:40-66.

 

SOURCE  Novo Nordisk  

 

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