Trial · SELECT

Semaglutide and cardiovascular outcomes: SELECT

Landmark CV outcomes trial of 17,604 adults establishing that semaglutide 2.4 mg reduces MACE in overweight/obese patients with pre-existing cardiovascular disease — independent of glycemic status.

Design

Multicenter, double-blind, placebo-controlled, event-driven trial in 17,604 adults ≥ 45 years with BMI ≥ 27 and established CVD but no diabetes. Median follow-up 39.8 months.

Primary outcome

First MACE event in 6.5% of semaglutide group vs 8.0% placebo (HR 0.80; 95% CI 0.72–0.90; p < 0.001). Number needed to treat over ~33 months: ~67.

Regulatory impact

In March 2024, the FDA expanded Wegovy's label to include cardiovascular risk reduction in adults with established CVD and overweight or obesity — the first weight-management drug to carry a CV-risk-reduction indication.