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

<p>Objective:</p><p>The obesity epidemic is a public health concern, warranting further research into</p><p>pharmacological treatments for weight management as an adjunct to lifestyle interventions. The</p><p>Semaglutide Treatment Effect in People with obesity (STEP) program aims to investigate the effect of</p><p>semaglutide versus placebo on weight loss (WL), safety, and tolerability in adults with obesity or</p><p>overweight.</p><p>Methods:</p><p>Across five phase 3 trials (NCT03548935– weight management, NCT03552757– weight</p><p>management (WM) in type 2 diabetes, NCT03611582– WM with intensive behavioral therapy,</p><p>NCT03548987– sustained WM, NCT03693430– long-term WM), ~5000 participants are randomized</p><p>to receive semaglutide 2.4 mg once weekly subcutaneously versus placebo. Results are available in</p><p>2020/2021. For all trials, the primary endpoint is change from baseline to end of treatment in body</p><p>weight</p><p>Results:</p><p>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.</p><p>Conclusions:</p><p>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>