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 into

pharmacological treatments for weight management as an adjunct to lifestyle interventions. The

Semaglutide Treatment Effect in People with obesity (STEP) program aims to investigate the effect of

semaglutide versus placebo on weight loss (WL), safety, and tolerability in adults with obesity or

overweight.

Methods:

Across five phase 3 trials (NCT03548935– weight management, NCT03552757– weight

management (WM) in type 2 diabetes, NCT03611582– WM with intensive behavioral therapy,

NCT03548987– sustained WM, NCT03693430– long-term WM), ~5000 participants are randomized

to receive semaglutide 2.4 mg once weekly subcutaneously versus placebo. Results are available in

2020/2021. For all trials, the primary endpoint is change from baseline to end of treatment in body

weight

Results:

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.