Backward, Denmark, November 5, 2020 / PRNewswire / – The results of a Phase 3A trial showed that the investigational drug semaglutide 2.4 mg once weekly as an adjunct to intensive behavior therapy (IBT) was significantly more subcutaneous than place plus plus IBT once weekly. Demonstrated weight loss.[i] The STEP 3 Phase 3A trial examined the efficacy and safety of once-weekly semaglutide 2.4mg after 68 weeks of treatment compared with placebo adjacent to IBT, including 30 consultation sessions with a registered dietitian for 68 weeks, As well as a low-calorie diet and increased physical activity. Adults participating in the trial were obese (BMI / 30 kg / m)2) Or overweight (BMI kg27 kg / m2) With at least one weight-related co-morbidity and without type 2 diabetes (HBA)1c <6.5%). An oral presentation of the new data was given today at the Obesity Week 2020 interactive congress.
Two different statistical approaches to evaluate the effects of seglutide 2.4 mg were used in the STEP3 test; A primary statistical approach that assesses treatment effects regardless of adherence to or use of other anti-obesity treatments, and a secondary statistical approach that evaluates treatment effects if all participants in the trial followed a randomized treatment and no Other treatment methods did not begin. .
Based on the primary statistical approach, those treated with 2.4 mg once-weekly semaglutide in addition to IBT lost an average of 16.0% of their body weight from baseline, while those receiving placebo plus IBT (estimated difference) were 5.7. With%: – 10.3 [95% confidence interval: -12.0, -8.6]; p <0.0001). In addition, more people treated with semiglutide 2.4 mg plus IBT lost more than or equal to 5% of their body weight compared to placebo plus IBT (87% vs. 48%, respectively).
“Given the many weight-loss-related challenges faced by obese people, patients, and physicians, additional medical therapies are needed to support lifestyle interventions, such as IBT, which are extremely intense weight gain. Reducing approach, “said the professor Tom weiden, Principal investigator and professor of psychology in psychiatry at Perelman School of Medicine University of Pennsylvania. “When I am added to IBT I am encouraged to see significant additional weight loss and improvement in heart disease risk factors, which is achieved with semaglutide 2.4 mg.”
Weight loss of over 10%, 15% and 20% compared to 27%, 13% and 4% was achieved by 75%, 56% and 36% of people with semaglutide 2.4 mg plus IBT, respectively. Those treated with placebo plus IBT. In this trial, semiglutide 2.4 mg plus IBT demonstrated greater improvement in cardiometabolic risk factors compared to waist circumference (-14.6 vs -6.3 cm) and blood pressure (-5.6 vs 1.6 mmHg), as compared to plusus IBT.
When evaluating treatment effects based on a secondary statistical approach, people treated with semaglutide 2.4 mg plus IBT lost a mean weight of 17.6%, compared to 5.0% with placebo plus IBT. Additionally, 90% of those receiving semaglutide 2.4 mg plus IBT lost 5% more weight after 68 weeks compared to 50% with placebo plus IBT.
“Obesity can have a direct impact on health and is associated with many weight related diseases. A medical practice is needed to develop treatment options to help people lose weight and keep it off, ” Mads Crogsgaard Thomson, Executive vice president and chief scientific officer of Novo Nordisk. “We are pleased with the first complete Phase 3 results of the STEP test program, indicating that semiglutide can almost triple the amount of weight loss achieved with IBT alone, in addition to 2.4 mg IBT, which increases semaglutide 2.4 mg to one Makes meaningful future treatment options for obese people. “
Semaglutide 2.4 mg was well tolerated and no new safety signs were identified. The most common adverse events in those treated with semaglutide 2.4 mg were gastrointestinal events, as seen in previous trials with GLP-1 receptor agonists.
About semaglutide 2.4 mg for weight management
Once-weekly SC seglutide 2.4 mg is being investigated by Novo Nordisk as a possible treatment for obesity. Semaglutide is an analog of human glucagon-like peptide-1 (GLP-1) hormone, with 94% similarity to the original human GLP-1 molecule.[2, 3] It motivates people to lose weight by reducing hunger, increasing feelings of fullness and thereby helping people to eat less and reduce their food shortages.
About STEP 3 and STEP clinical trial program
STEP 3 was a 68-week phase 3a randomized, double-blind, multicentre, placebo-controlled trial that used safety and efficacy of once-weekly SC seglutide 2.4 mg with placebo when used as an adjunct to IBT. Used to compare , Behavioral support, and a low-calorie diet). Randomized trial (in a 2: 1 ratio) 611 adults with obesity (BMI kg30 kg / m2), Or overweight (BMI kg27 kg / m2) With at least one weight-related comorbidity and without type 2 diabetes (HBA)1c <6.5%). The primary endpoints of the trial were changes in the proportion of participants achieving equal or greater body weight (%) and 5% weight loss, both assessed from baseline to end of treatment (week 68). Confirmatory secondary endpoints include: the proportion of participants who achieved weight loss of 10% and greater than or equal to 15%, and changes in waist circumference, systolic blood pressure, and physical functioning on the 36-item Short Form Survey (SF-36). . , All assessed from baseline to end of treatment (week 68).
Step (semagglutide Treatment IFight in PEopel with Obesity) is a phase 3 clinical development program in which once-weekly SC seglutide in obesity is 2.4 mg. The global Phase 3A program consists of four trials and has enrolled approximately 4,500 adults with overweight or obesity.
Obesity is a chronic disease that requires long-term management.[6, 7] It is associated with several serious health complications and decreased life expectancy.[8, 9] Obesity-related complications are numerous and include type 2 diabetes, heart disease, Obstructive sleep apnea, nonalcoholic fatty liver disease And some types of cancer.
The global increase in prevalence of obesity is a public health issue that has serious cost implications for health systems. In 2016, 13% of adults, or about 650 million adults, were living with obesity worldwide.
About Novo Nordisk
Novo Nordisk is a major global healthcare company, founded in 1923 and headquartered in Denmark. We aim to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We are working to advance scientific breakthroughs, increase access to our medicines and prevent and ultimately cure disease. Novo Nordisk employs about 44,000 people in 80 countries and markets its products in about 170 countries. For more information, visit novonordisk.com, Facebook, Twitter, Linkedin, Youtube.
- Vaden T, Bailey TS, Billings LK., and others. Intensive behavioral therapy in the subject with semaglutide 2.4 mg and overweight or obese (STEP 3). Presented at the 38th Annual Meeting of Obesity Reduction (TOS) Obesityweek®, held November 2–6, 2020 [Oral 084].
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- DP Guh, W. Zhang, N. Bansbach, and others. The incidence of obesity and overweight-related co-morbidities: a systematic review and meta-analysis. BMC Public Health. 2009; 9: 1–20.
- A. Peters, JJ Barrendregat and F. Villekens, and others. Obesity in adulthood and its consequences for life expectancy: a life-table analysis. Anal of internal medicine. 2003; 138: 24–32.
- AS Gamy, SM Caples and VK Somaras. Obesity and obstructive sleep apnea. Endocrinology and Metabolism Clinic of North America. 2003; 32: 869–94.
- G. Vernon, A. Baranova and ZM Unosi. Systematic review: Epidemiology and natural history of non-alcoholic fatty liver disease and nonalcoholic steatohepatitis in adults. Aliment Pharmacol there. 2011; 34: 274–85.
- G Whitlock, S Lewington, P Sherlicker, and others. Body-mass index and cause-specific mortality in 900 000 adults: collaborative analysis of 57 prospective studies. Lancet. 2009; 373: 1083–1096.
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