Novo Nordisk (NVO) said Monday that its phase 3 trial evaluating CagriSema -- a fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg --met its primary endpoint in 1,206 overweight or obese patients with type 2 diabetes.

The trial showed a "statistically significant and superior weight loss" with CagriSema compared to placebo at week 68. Patients on CagriSema achieved a 15.7% weight loss, versus 3.1% in the placebo group, the company said.

Additionally, 89.7% of CagriSema-treated patients achieved at least 5% weight loss, which was a co-primary endpoint, compared with 30.3% with placebo.

Novo Nordisk said CagriSema was well-tolerated, with mostly mild to moderate gastrointestinal side effects.

The company plans to seek regulatory approval in Q1 2026.

Novo Nordisk shares were down more than 5% in recent premarket activity.