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# Data Support Wegovy Positive CV Outcomes
- URL: https://www.fdaweb.com/data-support-wegovy-positive-cv-outcomes/
- Published: 2023-11-13T12:00:00.000Z
- Updated: 2026-09-14T14:16:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155776

Novo Nordisk says data from its Phase 3 SELECT cardiovascular outcomes trial assessing the effects of once-weekly semaglutide 2.4 mg (Wegovy) in adults with established cardiovascular disease and overweight or obesity without diabetes showed that the drug was associated with a 20% risk reduction in MACE \[major adverse cardiovascular events\] over a period of up to five years versus placebo.

The company says that the findings showed that “risk reductions in MACE were achieved regardless of age, gender, ethnicity and starting body mass index (BMI). The results also demonstrated that the beneficial effects in MACE risk reduction were evident soon after treatment initiation, suggesting an effect that is more rapid than what would be expected if the cardiovascular effects were entirely mediated with the effects of semaglutide 2.4 mg on body weight reduction. This suggests that weight loss alone may not fully explain the benefits of semaglutide 2.4 mg in reducing the risk of MACE.”

Novo Nordisk also says the secondary endpoints also showed “beneficial effects” on other cardiovascular risk factors, including lowering blood pressure, cholesterol and blood sugar levels. “While the trial was not designed as a weight loss trial, participants in the trial who received semaglutide still lost an average of 9.4% of total body weight which was sustained throughout the trial,” it adds.

Novo Nordisk notes that it has filed for a label update for Wegovy to include an indication for risk reduction of major adverse cardiovascular events in adults with a BMI greater than 27 kg/m2 and established cardiovascular disease.