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The novel glucagon-like peptide-1 (GLP-1) analogue semaglutide reduced major adverse cardiovascular event (MACE) risk in top-line results from the phase IIIa SUSTAIN 6 trial, .
The trial showed success for the primary endpoint of noninferiority for cardiovascular death, myocardial infarction, and stroke compared with placebo and a statistically significant reduction on that combined endpoint as well.
Until last year, no diabetes drug had shown better than noninferiority in the FDA-mandated cardiovascular outcomes trials. Then the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) showed a relative 14% reduction in MACE compared with placebo in the EMPA-REG trial, drawing cheers from diabetes specialists gathered to hear the findings presented.
And in March, Novo said its current GLP-1 drug liraglutide (Victoza) cut major cardiovascular event rates in the LEADER trial.
For semaglutide, Novo Nordisk announced the top-line results Thursday based on about 250 MACE events. No other numerical findings were released. The company said it expected to file a new drug application with the FDA toward the end of the year.
Semaglutide was given subcutaneously once a week in the SUSTAIN 6 trial, which included about 3,300 people with type 2 diabetes randomized to semaglutide at a dose of 0.5 or 1.0 mg or to placebo, all atop standard-of-care for 104 weeks.
In total, Novo is conducting six phase III SUSTAIN trials with once-weekly semaglutide, with more than 7,000 participants.
The drug is also being studied in a once-daily subcutaneous dose for managing type 2 diabetes and weight and in an oral tablet form for type 2 diabetes.