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Novo Nordisk (NVO) announced Saturday that its FDA-approved weight loss therapy Wegovy, also known as semaglutide, generated cardiovascular benefits regardless of age, sex, ethnicity and level of obesity in a trial of phase 3.
In August, the Danish pharmaceutical company said that The SELECT trial achieved its main objective: the GLP-1 receptor agonist at a dose of 2.4 mg led to a 20% reduction in the risk of major adverse cardiovascular events (MACE), such as stroke, with a statistically significant effect.
Announcing its detailed results at a medical event hosted by the American Heart Association (AHA), the company said the reduction in MACE risk was seen regardless of age, sex, ethnicity, and body mass index ( initial BMI) of the patients.
Benefits were seen shortly after starting therapy, which the company says indicates there may not be a connection between the drug’s weight-loss effects and its cardiovascular benefits.
The global study enrolled more than 17,000 adults who were overweight or obese, had cardiovascular disease, and had no history of diabetes.
Other highlights from the trial indicate that semaglutide, compared to placebo, produced a statistically significant 28% reduction in the risk of heart attacks.
However, the findings of a 7% risk reduction in nonfatal stroke and a 15% risk reduction in cardiovascular death were not statistically significant.
Novo (NVO) said the 2.4 mg dose of semaglutide in SELECT appeared safe and demonstrated a tolerability profile in line with previous studies.
The company expects the US and EU to decide next year on its attempt to expand semaglutide labeling to include a cardiovascular risk reduction indication.