![]() ![]() ![]() Previous studies in the STEP trial program have been limited to treatment durations of up to 68 weeks 6, 7, 8. In the STEP 1 and 3 trials in participants without type 2 diabetes, average placebo-subtracted weight losses of 12.4% and 10.3%, respectively, were seen with semaglutide 2.4 mg at week 68 (refs. At a dose of 2.4 mg once-weekly, subcutaneous semaglutide was approved in the United States, Europe, the United Kingdom and Canada for weight management in adults with overweight (BMI ≥ 27 kg m –2 with at least one weight-related comorbidity) or obesity (BMI ≥ 30 kg m –2) 2, 3, 4, 5, based on results from the Semaglutide Treatment Effect in People with Obesity (STEP) clinical trial program. Semaglutide is a glucagon-like peptide-1 (GLP-1) analog approved for the treatment of type 2 diabetes (oral semaglutide and subcutaneous semaglutide) and for reducing the risk of cardiovascular events in people with type 2 diabetes and cardiovascular disease (subcutaneous semaglutide only) 2, 3, 4, 5. However, because behavioral intervention is often not associated with clinically meaningful and sustainable weight loss, pharmacotherapy is recommended as an additional tool for long-term weight management in people with a body mass index (BMI) of at least 30 kg m –2, or at least 27 kg m –2 in those with weight-related comorbidities 1. NCT03693430īehavioral intervention incorporating modifications in diet and physical activity remains the foundation of treatment for overweight and obesity. In summary, in adults with overweight (with at least one weight-related comorbidity) or obesity, semaglutide treatment led to substantial, sustained weight loss over 104 weeks versus placebo. Gastrointestinal adverse events, mostly mild-to-moderate, were reported more often with semaglutide than with placebo (82.2% versus 53.9%). More participants in the semaglutide group than in the placebo group achieved weight loss ≥5% from baseline at week 104 (77.1% versus 34.4% P < 0.0001). ![]() The mean change in body weight from baseline to week 104 was −15.2% in the semaglutide group ( n = 152) versus −2.6% with placebo ( n = 152), for an estimated treatment difference of −12.6 %-points (95% confidence interval, −15.3 to −9.8 P < 0.0001). From 5 October 2018 to 1 February 2019, 304 participants were randomly assigned to semaglutide 2.4 mg ( n = 152) or placebo ( n = 152), 92.8% of whom completed the trial (attended the end-of-trial safety visit). Efficacy was assessed among all randomized participants regardless of treatment discontinuation or rescue intervention. The co-primary endpoints were the percentage change in body weight and achievement of weight loss of ≥5% at week 104. The STEP 5 trial assessed the efficacy and safety of once-weekly subcutaneous semaglutide 2.4 mg versus placebo (both plus behavioral intervention) for long-term treatment of adults with obesity, or overweight with at least one weight-related comorbidity, without diabetes. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |