PR92874

BAGSVÆRD, Denmark, Nov. 5, 2021 /PRNewswire=KYODO JBN/ --

- The STEP 5 trial demonstrated an average weight loss of 15.2% with Wegovy(TM)

at 104-weeks when used with a reduced calorie meal plan and increased physical

activity vs. 2.6% with placebo

- The trial also showed that 77.1% of study participants who received

Wegovy(TM) lost at least 5% of their body weight, compared to 34.4% of those

who received placebo  

Results from the STEP 5 phase 3b trial, presented today at the ObesityWeek(R)

2021 interactive congress, showed that adults treated with Wegovy(TM)

(semaglutide 2.4 mg injection) achieved significant and sustained weight loss

over the two-year study period. The STEP 5 trial investigated Wegovy(TM) vs.

placebo, both used with a reduced calorie meal plan and increased physical

activity for the treatment of obesity (BMI greater than or equal to 30 kg/m2)

or overweight (BMI greater than or equal to 27 kg/m2) in 304 adults with at

least one weight-related comorbidity for 104 weeks (two years).[1]

In the STEP 5 trial, results showed that Wegovy(TM) used with a reduced calorie

meal plan and increased physical activity significantly reduced body weight

from baseline to week 104 compared to placebo (-15.2% vs. -2.6%, estimated

treatment difference: -12.6% -points [95% CI: -15.3, -9.8]; p<0.0001) . The

study also demonstrated that adults with overweight or obesity were more likely

to lose at least 5% of their body weight with Wegovy(TM) vs. placebo (77.1% vs.

34.4%; p<0.0001).

“People with obesity try on average seven times to lose weight before seeking

medical care. Once weight is lost, however, it all too often comes back, which

is why it is critically important to find options to help people living with

obesity lose weight and keep it off,” said W. Timothy Garvey, MD, Professor of

Medicine, Department of Nutrition Sciences at the University of Alabama in

Birmingham. “Results from the STEP 5 clinical trial demonstrated that adults

with obesity were able to lose weight whilst taking Wegovy(TM) and maintain the

weight loss at two years, which can help us better treat and manage obesity as

a chronic disease.”  

Based on 68-week trials, the most frequently reported adverse events with

Wegovy(TM) were nausea, diarrhoea, vomiting, constipation and abdominal

pain.[2],[3] In the STEP 5 trial, the safety profile of Wegovy(TM) was in line

with previous STEP phase 3a trials; 5.9% of patients treated with Wegovy(TM)

and 4.6% of patients treated with placebo permanently discontinued treatment as

a result of adverse reactions.[1]

“With current obesity treatments we tend to see a waning of the weight-lowering

effects of the treatment over time. We set out to investigate if that would

hold true also for semaglutide 2.4 mg. It is very encouraging for us to see

that even after two years of treatment with semaglutide 2.4 mg, we still see a

significant and sustained weight loss of 15%. We are very pleased with the

promise these findings offer to people living with obesity. For many people,

maintaining an achieved weight loss over time is an equally big challenge as

achieving the weight loss in the first place,” said Martin Holst Lange,

executive vice president, Development at Novo Nordisk.

About STEP 5 and the STEP clinical trial programme

STEP 5 was a phase 3b randomised, double-blind, placebo-controlled trial that

investigated the effect of semaglutide 2.4 mg as an adjunct to lifestyle

intervention (–500 kcal/day diet together with 150 minutes/week of physical

activity) on sustained weight loss (for 2 years) in 304 adults with obesity,

without type 2 diabetes. Participants were randomly assigned (in a 1:1 ratio)

to once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks.

The primary endpoint of the trial was a change in body weight (%) and a

proportion of participants who achieved greater than or equal to 5% weight loss

at week 104. Key secondary objectives included the proportion of participants

achieving a body weight reduction &#8805;10% or &#8805;15% from baseline at 104

weeks and change from baseline to week 104 in waist circumference and systolic

blood pressure.[1]  

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.[2] 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.

About Wegovy(TM) (semaglutide 2.4 mg) for weight management

Wegovy(TM) (semaglutide 2.4 mg) is currently approved for weight management as

an adjunct to diet and exercise in the US and UK only and is under review by

the European Medicines Agency (EMA) and several other health authorities.

Semaglutide is an analogue of the human glucagon-like peptide-1 (GLP-1)

hormone, with 94% similarity to the native human GLP-1 molecule.[4],[5] It

induces weight loss by reducing hunger, increasing feeling of fullness and

thereby helping people eat less and reduce their food cravings.[4]

About obesity

Obesity is a chronic disease that requires long-term management.[6],[7] It is

associated with many serious health complications and decreased life

expectancy.[8],[9] Obesity-related complications are numerous and include type

2 diabetes,[7] heart disease,[7] obstructive sleep apnoea,10 non-alcoholic

fatty liver disease11 and certain types of cancer.[12] The current COVID-19

pandemic has highlighted that obesity also increases the risk for severe

illness and hospitalisation due to COVID-19.[13],[14]  

The global increase in the prevalence of obesity is a public health issue that

has severe cost implications to healthcare systems. Approximately 650 million

adults are estimated to live with obesity worldwide.[15]

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 47,000 people in 80 countries and markets its products in around

170 countries. For more information, visit novonordisk.com, Facebook, Twitter,

LinkedIn, YouTube.

References

1. Garvey WT, et al. Two-year Effect of Semaglutide 2.4 mg vs Placebo in Adults

with Overweight or Obesity (STEP 5). Presented at the 39th Annual Meeting of

The Obesity Society (TOS) held at ObesityWeek®, November 1–5, 2021.

2. 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.

3. FDA. Wegovy®(semaglutide 2.4 mg) prescribing information. Available at:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215256s000lbl.pdf.

Last Accessed: November 2021.

4. 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.

5. 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.

6. 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: November 2021.

7. WHO. Obesity: Preventing and managing the global epidemic. Available at:

http://www.who.int/iris/handle/10665/42330 Last accessed: November 2021.

8. 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.

9. 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.

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

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

11. 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.

12. 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.

13. Finer N, Garnett SP and Bruun JM. COVID-19 and obesity. Clin Obes. 2020;

10:e12365.

14. Ryan DH, Ravussin E and Heymsfield S. COVID 19 and the Patient with Obesity

- The Editors Speak Out. Obesity (Silver Spring). 2020; 28:847.

15. World Health Organization. Obesity and Overweight Factsheet no. 311.

Available at: http://www.who.int/mediacentre/factsheets/fs311/en/. Last

accessed: November 2021.

[*] Based on treatment policy estimand results

Source: Novo Nordisk