Data from STEP clinical trial program evaluating effect of semaglutide 2.4 mg in people with obesity to be presented at 2021 ENDO annual meeting

Rhea-AI Summary

Novo Nordisk has announced pivotal results from the STEP clinical development program for semaglutide 2.4 mg, set to be presented at the ENDO Annual Meeting from March 20-23, 2021. The STEP program, involving approximately 4,500 adults, investigates obesity management's efficacy and safety. With findings that could aid in FDA approval, the trials include STEP 1 and STEP 2, focusing on weight loss and cardiometabolic health. The anticipated FDA decision follows a filing in December 2020, highlighting the drug's potential impact on obesity-related health issues.

Positive

• Successful trials from the STEP program involving around 4,500 participants.
• Potential FDA approval anticipated after filing in December 2020.
• Presenting significant data at a major medical conference.

Negative

• None.

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

FAQ

What is the purpose of the STEP clinical trial program by Novo Nordisk?

The STEP clinical trial program aims to evaluate the efficacy and safety of semaglutide 2.4 mg for weight management in adults with obesity.

When will the results from the STEP trials be presented?

Results from the STEP trials will be presented at the ENDO Annual Meeting from March 20-23, 2021.

What is the significance of semaglutide 2.4 mg in obesity treatment?

Semaglutide 2.4 mg is being investigated as a potential treatment for obesity, showing promising results in weight management and related health conditions.

What is the expected impact of the STEP trial results on Novo Nordisk's stock (NVO)?

Positive trial results may enhance investor confidence and potentially lead to an increase in NVO stock price, especially if FDA approval follows.

What data will be presented regarding the STEP 4 trial?

The STEP 4 trial focuses on weight maintenance with semaglutide 2.4 mg, and results will be presented live on March 23, 2021.