Novo Nordisk has presented new data from a sub-analysis of the phase 3 REDEFINE 1 trial at the European Association for the Study of Diabetes (EASD) Congress 2025, held from 15–19 September in Vienna, Austria. The sub-analysis evaluated the efficacy and safety of once-weekly Cagrilintide 2.4 mg monotherapy alongside lifestyle intervention in adults with obesity or overweight and a weight-related comorbidity, but without diabetes.
Cagrilintide is a long-acting amylin analogue that mimics the naturally occurring hormone Amylin and works via a different mechanism than currently approved GLP-1-based treatments for weight loss. These results represent the first and only phase 3 data of an investigational long-acting amylin analogue monotherapy for obesity management.
In the REDEFINE 1 trial, cagrilintide achieved significant weight loss, with participants experiencing an average 11.8% reduction in body weight compared to 2.3% with placebo after 68 weeks (among those who adhered to treatment). Additionally, 31.6% of participants receiving cagrilintide achieved ≥15% weight loss, compared with 4.7% on placebo.
Cagrilintide was generally well tolerated. The most common side effects were gastrointestinal (nausea, vomiting, diarrhoea, and constipation), which were mostly temporary and mild to moderate. Nausea led to permanent treatment discontinuation in 1.0% of participants, versus 0.1% on placebo.
“These data highlight the exciting potential of cagrilintide to offer an alternative approach for people to lose weight, achieve health-related outcomes and manage their obesity, including a favourable tolerability profile,” said lead investigator Timothy Garvey, MD, professor of medicine and director of the Diabetes Research Center at the University of Alabama at Birmingham. “Like other chronic diseases, we need a range of treatment options to address the individual needs of people with obesity, such as their own specific response to treatment.”
When considering all participants regardless of adherence, average weight loss with cagrilintide was 11.5% compared to 3.0% with placebo, and 31.0% achieved ≥15% weight loss versus 5.2% on placebo.
The dedicated phase 3 RENEW programme is scheduled to begin in Q4 2025 and will further evaluate cagrilintide’s efficacy and safety in people with obesity or overweight.
“Our current and future therapies aim to help people with obesity achieve meaningful weight loss and broader health benefits. With the global scale of obesity, further scientific innovation and therapy options are needed to meet every individual's needs and preferences,” said Martin Holst Lange, chief scientific officer and executive vice president of Research & Development at Novo Nordisk. “In our clinical trials, cagrilintide has provided substantial weight loss, in a distinct manner compared to approved obesity medications, and appears well-tolerated. We’re excited that these data, the first phase 3 data of a next-generation amylin therapy, show promise and we look forward to further investigating cagrilintide’s potential in the dedicated phase 3 RENEW programme.”