Topline results from the large-scale Semaglutide Effects on Heart Disease and Stroke in Patients with Overweight or Obesity (SELECT) clinical study released today show that the Novo Nordisk obesity drug reduces the risk of major adverse cardiovascular events by 20 percent. The SELECT trial is the first to demonstrate the long-term cardiovascular benefits of an obesity medication.
The double-blinded trial, launched in 2018 and completed in late June this year, compared once weekly 2.4 mg of semaglutide via subcutaneous administration with placebo as an adjunct to standard-of-care prevention for major adverse cardiovascular events (MACE) over a period of up to five years. SELECT enrolled 17,604 patients overweight or with obesity who were over the age of 45 and had established cardiovascular disease (CVD) with no prior history of diabetes.
“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. “SELECT is a landmark trial and has demonstrated that semaglutide 2.4 mg has the potential to change how obesity is regarded and treated.”
The trial achieved its primary endpoint of MACE reduction by 20% for people treated with semaglutide. The primary endpoint was defined as the composite outcome of the first occurrence of MACE defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. In total, 1,270 MACEs occurred during the study with all three components of the primary endpoint contributing to MACE reduction. Safety data for semaglutide was in line with previous clinical trials of the drug, which showed it to be safe and well-tolerated by patients.
The drug, which is sold under the trade name Wegovy, was first approved by the FDA in June 2021 for chronic weight management in adults with obesity (BMI of 30 kg/m2 or greater) or overweight (BMI of 27 kg/m2 or greater) with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol), for use in addition to a reduced calorie diet and increased physical activity. The drug is a glucagon-like peptide-1 (GLP-1) agonist. The drug works by mimicking the hormone GLP-1 which targets areas of the brain that regulate appetite and food intake. Wegovy has been launched as an obesity medication in the U.S., Denmark, Norway, and Germany.
The company also has a clinical trial collaboration with Gilead Sciences for the use of semaglutide as a treatment for non-alcoholic steatohepatitis (NASH) and announced in December of 2020 that it was developing the drug as a potential treatment in Alzheimer’s disease.
Novo Nordisk said that it anticipates filing for a label indication expansion for approval in the U.S. and E.U. some time later this year. Full results of the clinical trial will also be released at a later date.
