4451-STEP TEENS-semaglutide effect in adolescents with obesity

• Research type

  Research Study

• Full title

  Effect and safety of semaglutide 2.4 mg once weekly on weight management in adolescents with overweight or obesity

• IRAS ID

  266732

• Contact name

  Billy White

• Contact email

  billy.white@nhs.net

• Eudract number

  2018-002431-18

• Duration of Study in the UK

  2 years, 4 months, 11 days

• Research summary

  Summary of Research
  Obesity is currently one of the most significant public health challenges. There has been a dramatic increase in the prevalence of obesity among adults, children and adolescents in recent years with increasing trends in both developed and developing countries causing an immense burden on health care systems. Around 2.1 billion people worldwide are currently estimated to be either overweight or obese.\nSimilarly to obesity in adults, children with obesity can have multiple immediate serious comorbidities. Obesity in childhood can have profound long-term consequences as it tracks strongly into adulthood, especially in those with severe obesity, which also increases the severity of their future health risks.\nIn studies conducted in children and adolescents with obesity, weight loss has been associated with improvements in cardiometabolic risk factors, including measures of glycaemic control, beta-cell function, insulin sensitivity/resistance, lipid profile, systolic/diastolic blood pressure and metabolic syndrome.\n\nThis trial is being conducted to assess the effect and safety of semaglutide in the paediatric population in order to address the unmet need for treatment of adolescents ages 12 to <18 years with obesity. Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist (RA) currently under development by Novo Nordisk for the weight management indication. Semaglutide stays in the body for a long time, it takes around 160 hours for the levels to drop to half, making it suitable for once-weekly dosing. GLP-1 is a physiological regulator of appetite and GLP-1 receptors are present in several areas of the brain involved in appetite regulation.\n\nIn this study adolescents will receive lifestyle modification advice through a reduced calorie diet and increased physical activity. They will also receive either semaglutide 2.4mg once a week or placebo. The participants will receive treatment for 68 weeks and will be on trial for around 89 weeks in total.

  Summary of Reesults
  A lay summary of results can be found at https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.novonordisk-trials.com%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7C61c7e7808f764e20223708dac8b9b822%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638042997224666023%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=OwnPebL8j%2F5EpiSqdl9pHlMotFpdZjz65uvnSPJONIY%3D&reserved=0

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  19/YH/0247

• Date of REC Opinion

  25 Sep 2019

• REC opinion

  Further Information Favourable Opinion