Treatment with Wegovy (semaglutide) was associated with significant weight loss over a 2-year study period, according to findings from the phase 3b STEP 5 trial.
The STEP 5 trial (ClinicalTrials.gov Identifier: NCT03693430) compared the efficacy and safety of Wegovy, a GLP-1 receptor agonist, to placebo in 304 adults who were overweight (BMI 27kg/m2 or greater) or obese (BMI 30kg/m2 or greater). Patients were randomly assigned to receive Wegovy 2.4mg subcutaneously once weekly or placebo, in addition to a reduced calorie meal plan and increased physical activity.
The coprimary endpoints were the percentage change in body weight and the number of patients who achieved body weight reduction greater than or equal to 5% from baseline to week 104.
Results showed that patients treated with Wegovy achieved a 15.2% reduction in body weight at week 104 compared with a 2.6% reduction for those who received placebo (estimated treatment difference: -12.6% points; 95% CI, -15.3, -9.8; P <.0001). Moreover, 77.1% of patients treated with Wegovy lost at least 5% of their body weight vs 34.4% of those who received placebo (P <.0001).
The most common adverse events reported with Wegovy were nausea, diarrhea, vomiting, constipation, and abdominal pain. More patients in the Wegovy arm permanently discontinued treatment due to adverse events compared with the placebo arm (5.9% vs 4.6%, respectively).
“Results from the STEP 5 clinical trial demonstrated that adults with obesity were able to lose weight while taking Wegovy and maintain the weight loss at 2 years, which can help us better treat and manage obesity as a chronic disease,” said W. Timothy Garvey, MD, Professor of Medicine, Department of Nutrition Sciences at the University of Alabama in Birmingham.
Wegovy is currently approved as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of at least 30kg/m2 or 27kg/m2 or greater in the presence of at least 1 weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, dyslipidemia).
Wegovy™ demonstrated significant and sustained weight loss in two-year study in adults with obesity. News release. Novo Nordisk. November 5, 2021. Accessed November 9, 2021. https://www.prnewswire.com/news-releases/wegovy-demonstrated-significant-and-sustained-weight-loss-in-two-year-study-in-adults-with-obesity-301417583.html.