Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP 1–5 Randomized Trials

Objective:The obesity epidemic is a public health concern, warranting further research intopharmacological treatments for weight management as an adjunct to lifestyle interventions. TheSemaglutide Treatment Effect in People with obesity (STEP) program aims to investigate the effect ofsemaglutide versus placebo on weight loss (WL), safety, and tolerability in adults with obesity oroverweight.Methods:Across five phase 3 trials (NCT03548935– weight management, NCT03552757– weightmanagement (WM) in type 2 diabetes, NCT03611582– WM with intensive behavioral therapy,NCT03548987– sustained WM, NCT03693430– long-term WM), ~5000 participants are randomizedto receive semaglutide 2.4 mg once weekly subcutaneously versus placebo. Results are available in2020/2021. For all trials, the primary endpoint is change from baseline to end of treatment in bodyweightResults:Participants have a mean age of 46.2–55.3 years, mostly female (mean 74.1–81.0%), a mean body mass index of 35.7–38.5 kg/m2and mean waist circumference of 113.0–115.7 cm.Conclusions:The STEP program evaluates the efficacy and safety of semaglutide 2.4 mg subcutaneously once-weekly in a broad population. The trials will provide insights on weight management in people with obesity with and without type 2 diabetes, long-term follow-up, and mitigating development of comorbidities and complications.</p