Wegovy demonstrated significant and sustained weight loss in two-year study in adults with obesity – Novo Nordisk

Results from the STEP 5 phase IIIb trial, presented by Novo Nordisk at the Obesity Week 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 greater than 30 kg/m2) or overweight (BMI greater than 27 kg/ m2) in 304 adults with at least one weight-related comorbidity for 104 weeks (two years). 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. In the STEP 5 trial, the safety profile of Wegovy was in line with previous STEP phase IIIa 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.

About STEP 5 and the STEP clinical trial programme : STEP 5 was a phase IIIb randomised, double-blind, placebo-controlled trial that investigated the effect of semaglutide 2.4 mg as an adjunct to lifestyle intervention (–500 kcal/day diet together with 150 minutes/week of physical activity) on sustained weight loss (for 2 years) in 304 adults with obesity, without type 2 diabetes. Participants were randomly assigned (in a 1:1 ratio) to once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks. The primary endpoint of the trial was a change in body weight (%) and a proportion of participants who achieved greater than or equal to 5% weight loss at week 104. Key secondary objectives included the proportion of participants achieving a body weight reduction greater than 10% or greater than 15% from baseline at 104 weeks and change from baseline to week 104 in waist circumference and systolic blood pressure.

STEP (Semaglutide Treatment Effect in People with obesity) is a phase III clinical development programme with once-weekly subcutaneous semaglutide 2.4 mg in obesity. The global clinical phase IIIa programme consists of four trials and has enrolled approximately 4,500 adults with overweight or obesity. In the STEP trials, the primary estimand (treatment policy estimand) assessed effects regardless of treatment adherence or initiation of other anti-obesity therapies. The secondary estimand (trial product estimand) assessed effects if all people adhered to treatment and did not initiate other anti-obesity therapies.

See-Garvey WT, et al. “Two-year Effect of Semaglutide 2.4 mg vs Placebo in Adults with Overweight or Obesity (STEP 5)”. Presented at the 39th Annual Meeting of The Obesity Society (TOS) held at ObesityWeek, November 1–5, 2021.