On Monday, Novo Nordisk A/S NVO announced headline results from the REDEFINE 2 phase 3 trial in the global REDEFINE program.

REDEFINE 2 is a 68-week efficacy and safety trial investigating once-weekly subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to placebo.

The trial included 1,206 randomized people with obesity or overweight, type 2 diabetes, and a mean baseline body weight of 102 kg.

The REDEFINE 2 trial was based on a flexible protocol, allowing patients to modify their dosing throughout the trial.

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After 68 weeks, 61.9% of patients treated with CagriSema were on the highest dose.

When evaluating treatment effects, if all people adhered to treatment, people treated with CagriSema achieved a weight loss of 15.7% after 68 weeks compared to 3.1% with placebo.

A co-primary endpoint was a weight loss of 5% or more after 68 weeks, which was achieved by 89.7% of patients on CagriSema, compared to 30.3% by placebo.

When applying the treatment policy estimand, people treated with CagriSema achieved a superior weight loss of 13.7% compared to 3.4% with placebo.

In the trial, CagriSema appeared to have a safe and well-tolerated profile. The most common adverse events with CagriSema were gastrointestinal, and the vast majority were mild to moderate and diminished over time, consistent with the GLP-1 receptor agonist class.

In December, in the REDEFINE 1 Phase 3 trial, CagriSema achieved a weight loss of 22.7% after 68 weeks compared to a reduction of 11.8% with cagrilintide 2.4 mg, 16.1% with semaglutide 2.4 mg and 2.3% with placebo alone, below the Street expectations of 25%.

Novo Nordisk expects to file for the first regulatory approval of CagriSema in the first quarter of 2026.

The detailed results from REDEFINE 1 and REDEFINE 2 will be presented at a scientific conference in 2025.

Price Action: At the last check on Tuesday, NVO stock was up 0.49% at $79.35 during the premarket session.

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