Novo Nordisk announces positive Phase 3 results for CagriSema

DENMARK— Novo Nordisk, the Danish pharmaceutical leader, has shared promising results from its REDEFINE 2 phase 3 trial, part of the global REDEFINE program.

This 68-week study evaluated the efficacy and safety of CagriSema, a once-weekly subcutaneous injection combining cagrilintide (2.4 mg) and semaglutide (2.4 mg), in adults with obesity or overweight and type 2 diabetes.

The trial compared CagriSema against a placebo and included 1,206 participants with an average baseline weight of 102 kg.

The trial achieved its primary goal by demonstrating that CagriSema led to significantly greater weight loss than the placebo.

When all participants adhered to treatment, those receiving CagriSema experienced an average weight loss of 15.7% after 68 weeks, compared to just 3.1% for the placebo group.

Additionally, 89.7% of participants on CagriSema achieved at least a 5% reduction in body weight, compared to only 30.3% in the placebo group.

Using a treatment policy estimand approach, which accounts for all randomized participants regardless of adherence, CagriSema still showed superior results with a 13.7% weight loss versus 3.4% for placebo.

The trial also allowed flexible dosing adjustments, with nearly 62% of participants on CagriSema reaching the highest dose by the end of the study.

Importantly, the treatment was well-tolerated, with gastrointestinal issues being the most common side effects.

These were generally mild to moderate and diminished over time, aligning with the safety profile of GLP-1 receptor agonists.

Martin Holst Lange, Novo Nordisk’s executive vice president for Development, emphasized that these findings highlight CagriSema’s potential as a next-generation therapy for individuals struggling with obesity or overweight and type 2 diabetes.

He expressed optimism about bringing this innovative treatment to regulatory authorities soon.

Novo Nordisk plans to file for regulatory approval of CagriSema in early 2026. Meanwhile, detailed results from both REDEFINE 1 and REDEFINE 2 trials will be shared at a scientific conference later this year.

These findings underscore Novo Nordisk’s commitment to addressing global challenges related to obesity and diabetes through groundbreaking therapies.

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