**Novo Nordisk has announced headline results from a late-stage study of its obesity candidate CagriSema in adults with type 2 diabetes (T2D).**
The phase 3 REDEFINE 2 trial has been evaluating once-weekly subcutaneous CagriSema, a fixed dose combination of cagrilintide and semaglutide, against placebo in more than 1,200 T2D patients who are either obese or overweight.
The study met its primary endpoint, with CagriSema demonstrating a statistically significant and superior weight loss at week 68 compared to placebo.
Among patients who adhered to treatment, those receiving CagriSema achieved a superior weight loss of 15.7% after 68 weeks compared to 3.1% randomised to placebo.
This decreased slightly when evaluating treatment effect regardless of adherence, with CagriSema-treated achieving a weight loss of 13.7% compared to 3.4% with placebo.
Novo said it expects to file for the first regulatory approval of CagriSema in the first quarter of 2026.
CagriSema is designed to induce weight loss by increasing feelings of fullness, which helps people eat less and reduce their calorie intake.
Beyond REDEFINE 2, Novo’s late-stage REDEFINE programme includes trials evaluating CagriSema in obese or overweight adults with one or more comorbidities and without T2D, adults with established cardiovascular disease with or without T2D and obese adults.
The drug is also being investigated in the REIMAGINE programme as a treatment for adults with T2D.
Martin Holst Lange, executive vice president for development at Novo, said: “The REDEFINE 2 results confirmed the superior efficacy of CagriSema in people with overweight or obesity and T2D.
“We look forward to bringing this second pivotal trial to regulatory authorities with the aim of making this next-generation therapy available to the millions of patients in need.”
The announcement comes less than two months after Novo [shared](https://pmlive.com/pharma_news/novo-shares-promising-results-for-high-dose-semaglutide-in-late-stage-obesity-study/) positive late-stage results for a higher dose of semaglutide in adults with obesity.
The phase 3b STEP UP trial has been comparing the experimental 7.2mg dose of semaglutide to the standard 2.4mg dose of the drug and placebo, all given once weekly in conjunction with lifestyle intervention.
Semaglutide 7.2mg is also currently being evaluated in the phase 3 STEP UP T2D trial in adults with obesity and T2D.