The semaglutide 2.4mg caused a mean reduction in body weight of 13.3% compared to a placebo's 2.6% loss, resulting in an estimated treatment difference of 10.7% weight reduction
A product image of Semaglutide in a tablet. (Credit: Novo Nordisk A/S)
Novo Nordisk announced that its semaglutide 2.4mg (wegovy) has reduced heart failure (HF)-related symptoms and physical limitations in HF patients with preserved ejection fraction and obesity in Phase 3 STEP HFpEF trial.
Semaglutide is a GLP-1 receptor agonist indicated as an adjunct treatment to a lowered-calorie diet and enhanced physical activity for chronic weight management.
The late-stage trial evaluated once-weekly semaglutide against placebo in adults with heart failure with preserved ejection fraction (HFpEF) and obesity.
According to the results, subcutaneous semaglutide 2.4mg also resulted in large improvements in exercise function and caused greater weight loss.
Additionally, the findings showed improvement in patient-reported Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS), evaluating the physical limitations and symptoms of HFpEF.
At 52 weeks, semaglutide caused a mean rise in the KCCQ-CSS of 16.6 points compared to a placebo’s 8.7 points, resulting in an estimated treatment difference of 7.8 points.
The GLP-1 receptor agonist also caused a mean reduction in body weight of 13.3% compared to a placebo’s 2.6% loss, resulting in an estimated treatment difference of 10.7% weight reduction.
In addition, the trial demonstrated a mean increase in six-minute walking distance of 21.5 metres at 52 weeks with semaglutide vs. 1.2 metres with placebo.
Novo Nordisk Development head and EVP Martin Lange said: “We are delighted with the results from STEP HFpEF, which show that semaglutide 2.4mg is able to ease the disease burden for people with HFpEF and obesity in a substantial way.
“These results come just weeks after the topline findings of our semaglutide 2.4mg and cardiovascular outcomes trial were announced and reinforce the potential of semaglutide 2.4mg to enhance cardiovascular care, beyond weight management.”
The STEP HFpEF trial enrolled 529 people with symptomatic HFpEF and obesity. Its dual primary endpoints were a change in KCCQ-CSS from baseline to week 52 and a change in body weight from baseline to week 52.
Key secondary endpoints included a change in 6MWD from baseline to week 52, a hierarchical composite endpoint and a change in C-reactive protein from baseline to week 52.
For regulatory submission, the Danish pharmaceutical company will include results from the ongoing STEP HFpEF-DM trial, another study of HFpEF and obesity in people with type 2 diabetes.