- The STEP 5 trial demonstrated an average weight loss of 15.2% with Wegovy™ at 104-weeks when used with a reduced calorie meal plan and increased physical activity vs. 2.6% with placebo
- The trial also showed that 77.1% of study participants who received Wegovy™ lost at least 5% of their body weight, compared to 34.4% of those who received placebo
BAGSVÆRD, Denmark, Nov. 5, 2021 /PRNewswire/ — Results from the STEP 5 phase 3b trial, presented today at the ObesityWeek® 2021 interactive congress, showed that adults treated with Wegovy™ (semaglutide 2.4 mg injection) achieved significant and sustained weight loss over the two-year study period. The STEP 5 trial investigated Wegovy™ vs. 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 (two years).1
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% vs. -2.6%, estimated treatment difference: -12.6% -points [95% CI: -15.3, -9.8]; p<0.0001)[*]. The study also demonstrated that adults with overweight or obesity were more likely to lose at least 5% of their body weight with Wegovy™ vs. placebo (77.1% vs. 34.4%; p<0.0001).
“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,” said W. Timothy Garvey, MD, Professor of Medicine, Department of Nutrition Sciences at the University of Alabama in Birmingham. “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.”
Based on 68-week trials, the most frequently reported adverse events with Wegovy™ were nausea, diarrhoea, vomiting, constipation and abdominal pain.2,3 In the STEP 5 trial, the safety profile of Wegovy™ was in line with previous STEP phase 3a trials; 5.9% of patients treated with Wegovy™ and 4.6% of patients treated with placebo permanently discontinued treatment as a result of adverse reactions.1
“With current obesity treatments we tend to …….