In overweight or obese adults with cardiovascular disease, semaglutide significantly reduces the incidence of major adverse cardiovascular events (MACE) and was well-tolerated, according to results from the SELECT trial.
Semaglutide, a drug developed by Novo Nordisk, is a GLP-1 receptor agonist that is indicated for chronic weight management alongside a reduced-calorie diet and increased physical activity. It is recommended for adults with a body mass index (BMI) of ≥30 kg/m2 (obese), adults with a BMI of ≥27 kg/m2 (overweight) and at least one weight-related comorbidity, or pediatric patients aged 12 years and older with a BMI at or over the 95th percentile for age and gender.
The SELECT trial was a randomized, double-blinded, placebo-controlled trial that evaluated the efficacy of once-weekly semaglutide (2.4 mg) as an adjunct to the standard of care for preventing MACE in overweight or obese adults with no prior history of diabetes. The trial enrolled 17,604 adults aged ≥45 years in 41 countries across 800 sites.
The primary endpoint was the composite outcome of the first occurrence of MACE, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Secondary outcomes included mortality, cardiovascular risk factors, glucose metabolism, body weight, and renal function.
Compared to those treated with the placebo, patients who received once-weekly semaglutide demonstrated a 20% reduction in MACE over a follow-up period of up to 5 years. The treatment appeared to have a safe and well-tolerated profile, in line with other trials of the drug at this dose.
“People living with obesity have an increased risk of cardiovascular disease but to date, there are no approved weight management medications proven to deliver effective weight management while also reducing the risk of heart attack, stroke or cardiovascular death. Therefore, we are very excited about the results from SELECT showing that semaglutide 2.4 mg reduces the risk of cardiovascular events,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk, in a press release. “SELECT is a landmark trial and has demonstrated that semaglutide 2.4 mg has the potential to change how obesity is regarded and treated.”
Due to these results, Novo Nordisk is expected to file for regulatory approvals of a label indication expansion for semaglutide in the US and EU.