Novo Nordis: Semaglutide Reduces Risk Of Major Adverse Cardiovascular Events

(RTTNews) - Novo Nordisk A/S (NVO) announced the top-line results from the sixth and last global phase 3a trial, SUSTAIN6, for semaglutide; a new GLP-1 analogue, which is administered subcutaneously once weekly in the SUSTAIN trials. The trial achieved its primary endpoint of showing non-inferiority of major cardiovascular events (MACE) with semaglutide compared with placebo, as well as a statistically significant reduction in cardiovascular risk.

The double-blinded trial investigated the long-term cardiovascular and other safety outcomes of 0.5 mg and 1.0 mg semaglutide compared with placebo, both in addition to standard-of-care. In the trial, approximately 3,300 people with type 2 diabetes were treated for 104 weeks.

In the trial, around 250 MACE were accrued. The primary endpoint of the study was defined as the composite outcome of the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.

The safety profile of semaglutide in SUSTAIN 6 was as expected and consistent with previous semaglutide clinical studies.

The company expects to file semaglutide for regulatory review in the US and EU in the fourth quarter of 2016.