Bagsværd,
The potential indication is for the treatment of adults with obesity (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) with at least one weight-related comorbidity, as an adjunct to reduced-calorie diet and increased physical activity.
The submission is based on the results from the STEP phase 3a clinical trial programme, which included more than 4,500 adults with obesity or overweight. Across the STEP programme, people with obesity treated with once-weekly semaglutide 2.4 mg achieved a statistically significant and superior reduction in body weight compared to placebo. Across STEP 1, 3 and 4 a weight loss of 15-18% was reported for people treated with semaglutide 2.4 mg. Furthermore, once-weekly semaglutide 2.4 mg appeared to have a safe and well-tolerated profile. The most common side effects were gastrointestinal and were transient, and mild or moderate in severity.
“Obesity is associated with a wide range of serious complications, yet many healthcare providers still do not have sufficient medical options available to help people with this chronic disease ,” said
About obesity and subcutaneous semaglutide 2.4 mg for weight management
Obesity is a chronic disease that requires long-term management. It is associated with many serious health consequences and decreased life expectancy. Obesity-related complications are numerous and include type 2 diabetes, heart disease, obstructive sleep apnoea, non-alcoholic fatty liver disease and cancer.
Once-weekly subcutaneous semaglutide 2.4 mg is being investigated by
About the STEP clinical programme
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 phase 3a programme consists of four trials and has enrolled approximately 4,500 adults with overweight or obesity.
STEP 1 – a 68-week safety and efficacy trial of subcutaneous semaglutide 2.4 mg versus placebo in 1,961 adults with obesity or overweight. For more information, please read the company announcement here
STEP 2 – a 68-week safety and efficacy trial of subcutaneous semaglutide 2.4 mg versus placebo and once-weekly subcutaneous semaglutide 1.0 mg in 1,210 adults with type 2 diabetes and either obesity or overweight. For more information, please read the company announcement here
STEP 3 – a 68-week safety and efficacy trial of subcutaneous semaglutide 2.4 mg versus placebo in combination with intensive behavioural treatment in 611 adults with obesity or overweight. For more information, please read the company announcement here
STEP 4 – a 68-week safety and efficacy trial of subcutaneous semaglutide 2.4 mg versus placebo in 803 adults with obesity or overweight who have reached the target dose of 2.4 mg after a 20-week run-in. For more information, please read the company announcement here
About
Further information
Media: | ||
+45 3079 3883 | mkd@novonordisk.com | |
+1 609 240 9429 | kiau@novonordisk.com | |
Investors: | ||
Daniel Muusmann Bohsen | +45 3075 2175 | dabo@novonordisk.com |
+45 3079 0301 | jvls@novonordisk.com | |
Ann Søndermølle Rendbæk | +45 3075 2253 | arnd@novonordisk.com |
+45 3079 4211 | mjhr@novonordisk.com | |
+1 609 235 2989 | krdb@novonordisk.com |
Company announcement No 74 / 2020
Attachment
- PR201204_semglutide_obesity_US_submission
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