Danish pharmaceutical company Novo Nordisk A/S (CPH:NOVO-B) (NYSE:NVO) on Monday reported results from the open-label phase 3 REDEFINE 4 trial evaluating CagriSema, a combination of cagrilintide 2.4 mg and semaglutide 2.4 mg, in 809 people with obesity.

In the 84-week trial, participants receiving CagriSema achieved 23% weight loss, compared with 25.5% for tirzepatide 15 mg, and 20.2% versus 23.6% using the treatment-regimen estimand. The trial did not meet its primary endpoint of demonstrating non-inferiority to tirzepatide for weight reduction.

CagriSema was generally safe and well tolerated, with mostly mild-to-moderate gastrointestinal adverse events consistent with GLP-1 receptor agonist therapy.

The drug was submitted to the US Food and Drug Administration (FDA) for weight management in December 2025, with a decision expected by late 2026. Separately, the REDEFINE 11 phase 3 trial exploring CagriSema 2.4/2.4 mg full weight-loss potential in obesity is expected to report data during the first half of 2027, while initiation of the phase 3 CagriSema higher-dose trial is planned for the second half of 2026.