On Monday, Novo Nordisk A/S NVO introduced headline outcomes from the REDEFINE 2 section 3 trial within the world REDEFINE program.
REDEFINE 2 is a 68-week efficacy and security trial investigating once-weekly subcutaneous CagriSema (a set dose mixture of cagrilintide 2.4 mg and semaglutide 2.4 mg) in comparison with placebo.
The trial included 1,206 randomized individuals with weight problems or chubby, kind 2 diabetes, and a imply baseline physique weight of 102 kg.
The REDEFINE 2 trial was primarily based on a versatile protocol, permitting sufferers to change their dosing all through the trial.
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After 68 weeks, 61.9% of sufferers handled with CagriSema had been on the very best dose.
When evaluating therapy results, if all individuals adhered to therapy, individuals handled with CagriSema achieved a weight lack of 15.7% after 68 weeks in comparison with 3.1% with placebo.
A co-primary endpoint was a weight lack of 5% or extra after 68 weeks, which was achieved by 89.7% of sufferers on CagriSema, in comparison with 30.3% by placebo.
When making use of the therapy coverage estimand, individuals handled with CagriSema achieved a superior weight lack of 13.7% in comparison with 3.4% with placebo.
Within the trial, CagriSema appeared to have a protected and well-tolerated profile. The commonest opposed occasions with CagriSema had been gastrointestinal, and the overwhelming majority had been gentle to average and diminished over time, in step with the GLP-1 receptor agonist class.
In December, within the REDEFINE 1 Part 3 trial, CagriSema achieved a weight lack of 22.7% after 68 weeks in comparison with a discount of 11.8% with cagrilintide 2.4 mg, 16.1% with semaglutide 2.4 mg and a pair of.3% with placebo alone, beneath the Road expectations of 25%.
Novo Nordisk expects to file for the primary regulatory approval of CagriSema within the first quarter of 2026.
The detailed outcomes from REDEFINE 1 and REDEFINE 2 will probably be introduced at a scientific convention in 2025.
Value Motion: On the final verify on Tuesday, NVO inventory was up 0.49% at $79.35 in the course of the premarket session.
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