Novo Builds Wegovy’s Cardio Case with Much-Anticipated Data Drop
Pictured: Signage outside Novo's office in California/iStock, Sundry Photography
Novo Nordisk on Saturday posted additional data from the Phase III SELECT trial, generating more evidence that its best-selling weight-loss drug, Wegovy (semaglutide), also offers cardiovascular benefits.
This data drop—simultaneously presented at the 2023 Scientific Sessions of the American Heart Association (AHA) and published in The New England Journal of Medicine—comes three months after Novo revealed initial findings from SELECT. At the time, the Danish drugmaker announced that a 2.4-mg injection of Wegovy led to a 20% drop in the risk of major adverse cardiovascular events (MACE).
Saturday’s readout expanded on these results and showed that the MACE risk reduction was consistent across different age, gender, ethnicity and body mass index subgroups. Novo also noted that Wegovy’s MACE benefits became apparent quickly after the initiation of treatment—a much more rapid onset of effect than if the heart health effects were mediated by weight loss alone.
SELECT was a randomized, double-blinded and parallel-group study that compared 2.4-mg Wegovy injections against placebo in terms of reducing the risk of MACE in overweight or obese patients with established cardiovascular diseases but without a history of diabetes. SELECT enrolled more than 17,000 adults aged 45 years and above with a BMI of at least 27 kg/m2.
In a statement, Martin Lange, executive vice president and head of development at Novo Nordisk, called SELECT a “landmark study,” adding that its results will be “instrumental in changing the way we perceive and treat obesity.”
SELECT also looked at the effects of Wegovy on the individual components of MACE and found that the drug could reduce the risk of non-fatal myocardial infarction or heart attack by a significant 28% versus placebo, according to the press announcement. Wegovy injections also led to substantial reductions in the risk of cardiovascular death and non-fatal stroke—15% and 7%, respectively—though these fell short of statistical significance.
Wegovy also aced its secondary endpoints, including composite heart failure events, risk of death from any cause, and a lowering of blood pressure, cholesterol and blood sugar levels.
Patients treated with Wegovy also saw strong weight-loss benefits and dropped 9.4% of their total body weight on average, an effect that was maintained throughout the study. Novo noted, however, that SELECT was not designed as a weight-loss trial.
The company has already submitted a filing to the FDA seeking to update Wegovy’s label with data from SELECT. The regulator has granted the filing priority review and is expected to release a verdict in 2024.