Data from a Phase III study released Tuesday found that Novo Nordisk’s Wegovy lowered the risk of cardiovascular complications and death by 20% versus placebo in overweight and obese adults.
Pictured: Novo Nordisk building at its site in California/iStock, hapabapa
Novo Nordisk’s weight-loss medication Wegovy (semaglutide) met its primary efficacy endpoint in the Phase III SELECT trial, demonstrating strong protective effect on cardiovascular health in overweight and obese adults without diabetes, the company announced Tuesday.
At a 2.4-mg dose level, once-weekly Wegovy injections significantly reduced the occurrence of major adverse cardiovascular events (MACE) by 20% as compared with placebo. This treatment effect was statistically significant, according to Novo’s announcement. Wegovy’s safety profile in SELECT was also in line with what had been established in previous studies.
SELECT defined MACE as a composite of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. Wegovy reduced the frequency of all three MACE components in SELECT.
Novo was trading approximately 11% higher in pre-market Tuesday following the data drop.
The results from SELECT highlight the potential dual benefits of Wegovy for overweight and obese adults who suffer from a heightened risk of cardiovascular disease, but for whom there are no approved weight management medications that can also protect heart health, according to Martin Holst Lange, Novo’s executive vice president for development.
“SELECT is a landmark trial and has demonstrated that semaglutide 2.4 mg has the potential to change how obesity is regarded and treated,” Lange said in a statement.
Novo will take these results to regulatory authorities and is planning to file for label expansions in the United States and EU this year. The company will also present more detailed data and analyses from SELECT at an upcoming congress.
Semaglutide is a therapeutic peptide that works by mimicking the GLP-1 hormone to activate its corresponding receptor. This in turn stimulates the pancreas to pump insulin into the blood in response to a high sugar concentration. The drug also moderates glucose production in the liver.
This mechanism of action has won semaglutide the FDA’s approval for weight loss and Type 2 diabetes, for which it is marketed under the brand names Wegovy and Ozempic, respectively.
Joining Novo in the weight loss and diabetes space is Eli Lilly, which owns Mounjaro (tirzepatide), an injectable anti-diabetic medication that works similarly to semaglutide. Unlike Novo’s asset, however, Mounjaro has yet to be authorized as a weight-loss treatment, though Lilly has been building up a strong clinical case for a label expansion.
In July 2022, data from the Phase III SURMOUNT-1 study showed that Mounjaro could elicit strong and sustained weight loss in overweight and obese adults without Type 2 diabetes. The company followed this up in April 2023, posting data from SURMOUNT-2 demonstrating that the treatment also lowered body weight in patients with both diabetes and overweight or obese.
Lilly has also been beefing up its weight-loss business, dropping $1.9 billion last month to acquire Versanis and its lead asset bimagrumab, which is being developed as a treatment to cut fat mass without affecting muscle mass.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
