Wegovy™ demonstrates sustained weight loss in two-year obesity study
Posted: 9 November 2021 | Anna Begley (European Pharmaceutical Review) | No comments yet
Novo Nordisk’s Wegovy™ reduced body weight by 15.2 percent versus 2.6 percent with placebo in Phase IIIb study.
Novo Nordisk has announced results from the STEP 5 Phase IIIb trial which showed that adults treated with Wegovy™ (semaglutide 2.4 mg injection) achieved significant and sustained weight loss over the two-year study period.
The trial investigated Wegovy™ versus placebo, both used with a reduced calorie meal plan and increased physical activity for the treatment of obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/ m2) in 304 adults with at least one weight-related comorbidity for 104 weeks.
In the STEP 5 trial, results showed that Wegovy used with a reduced calorie meal plan and increased physical activity significantly reduced body weight from baseline to week 104 compared to placebo (-15.2 percent versus -2.6 percent, with an estimated treatment difference of -12.6 percent). The study also demonstrated that adults who were overweight or obese were more likely to lose at least five percent of their body weight with Wegovy versus placebo (77.1 percent versus 34.4 percent).
Based on 68-week trials, the most frequently reported adverse events with Wegovy were nausea, diarrhoea, vomiting, constipation and abdominal pain. In the STEP 5 trial, the safety profile of Wegovy was in line with previous STEP phase IIIa trials; 5.9 percent of patients treated with Wegovy and 4.6 percent of patients treated with placebo permanently discontinued treatment as a result of adverse reactions.
“People with obesity try on average seven times to lose weight before seeking medical care. Once weight is lost, however, it all too often comes back, which is why it is critically important to find options to help people living with obesity lose weight and keep it off,” stated W. Timothy Garvey, Professor of Medicine at the University of Alabama in Birmingham, US. “Results from the STEP 5 clinical trial demonstrated that adults with obesity were able to lose weight whilst taking Wegovy and maintain the weight loss at two years, which can help us better treat and manage obesity as a chronic disease.”
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