Novo Nordisk reports cagrilintide provided average weight reduction of 11.8%

Novo Nordisk (NVO) presented data from a sub-analysis of the phase 3 REDEFINE 1 trial at the European Association for the Study of Diabetes congress 2025 from 15-19 September in Vienna, Austria. This sub-analysis evaluated the efficacy and safety of once-weekly cagrilintide 2.4 mg monotherapy, plus lifestyle intervention, for adults with obesity or overweight and a weight-related comorbidity without diabetes. Cagrilintide is a long-acting amylin analogue that mimics the naturally occurring hormone amylin and works differently than currently approved GLP-1-based treatments for weight loss. These findings represent the first and only phase 3 clinical trial data with an investigational long-acting amylin analogue monotherapy for the management of obesity. In REDEFINE 1, cagrilintide provided clinically meaningful weight loss, with an average body weight reduction of 11.8% compared to 2.3% with placebo after 68 weeks, if all participants adhered to treatment. Additionally, around 1 in 3 participants receiving cagrilintide achieved greater than or equal to 15% weight loss, compared to around 1 in 20 participants receiving placebo. Cagrilintide was well-tolerated, with the most common side effects being gastrointestinal, including nausea, vomiting, diarrhoea and constipation. These were mainly temporary and mild to moderate. Nausea led to permanent discontinuation of cagrilintide in 1% of participants, compared with 0.1% of participants for placebo. When evaluating the treatment effect regardless of adherence, average weight loss with cagrilintide was 11.5% compared to 3% with placebo after 68 weeks. Additionally, 31% of participants achieved greater than or equal to15% weight loss with cagrilintide compared to 5.2% with placebo. The dedicated phase 3 RENEW program will investigate the efficacy and safety of cagrilintide in people with obesity or overweight and is due to start in Q4.