Novo Nordisk Announces Phase 3 Data for Long-Acting Amylin Analog Cagrilintide, Demonstrating Average Weight Loss of 12.5 kg

On September 16, Novo Nordisk announced today at the 2025 European Association for the Study of Diabetes (EASD) Congress, held from September 15 to 19 in Vienna, Austria, the sub-analysis data from the REDEFINE 1 Phase 3 trial. This sub-analysis evaluated once-weeklyCagrilintide Efficacy and Safety of 2.4 mg Monotherapy Plus Lifestyle Intervention in Adults with Obesity or Overweight and Weight-Related Non-Diabetic Comorbidities.CagrilintideIs a long-acting amylin analogThing (amylin analogue），Mimicking the natural hormone amylin, which is different from currently approved GLP-1-based weight loss treatments. These findings represent the first and only one of its kind.Long-Acting Amylin Analog Monotherapy for ObesityPhase 3 clinical trial data with research significance.

In REDEFINE 1, if all participants adhere to the treatment,CagrilintideProvided clinically significant weight loss, with an average weight reduction of 11.8% after 68 weeks, compared to 2.3% in the placebo group. Additionally, those receivingCagrilintideApproximately one-third (31.6%) of participants in the treatment group achieved weight loss of ≥15%, compared with about one-twentieth (4.7%) of participants in the placebo group.

Chief Researcher,Timothy Garvey, MD, Professor of Medicine at the University of Alabama at Birmingham and Director of the Diabetes Research Center, stated:“Cagrilintide was well-tolerated, with the most common side effects being gastrointestinal reactions, including nausea, vomiting, diarrhea, and constipation. These were primarily temporary and mild to moderate in severity. Compared with 0.1% of participants in the placebo group, 1.0% of participants permanently discontinued the medication due to nausea. These data highlightCagrilintideThe exciting potential of providing alternative methods for people to lose weight, achieve health-related outcomes, and manage obesity, including good tolerance. As with other chronic diseases, we need a range of treatment options to meet the individual needs of people with obesity, such as their specific responses to treatment."

When evaluating the treatment effect, regardless of compliance, after 68 weeks,CagrilintideThe average weight loss rate was 11.5%, compared to 3.0% for the placebo. Additionally, compared to 5.2% of participants in the placebo group,CagrilintideGroup 31.0% of participants lost ≥15% of their body weight.

The dedicated Phase 3 RENEW program will investigateCagrilintideEfficacy and safety in obese or overweight populations, and will begin in the fourth quarter of 2025.

Martin Holst Lange, Chief Scientific Officer and Executive Vice President of R&D at Novo Nordisk, stated:"Our current and future therapies are designed to help obese patients achieve meaningful weight loss and broader health benefits. As the global obesity scale expands, further scientific innovation and treatment options are needed to meet everyone's needs and preferences. In our clinical trials, compared with approved obesity drugs,CagrilintideSignificantly reduced weight in a unique way and appears to be well-tolerated. We are pleased with these data, the first Phase 3 data from the next-generation amylin treatment, which show promise, and we look forward to further studying it in the dedicated Phase 3 RENEW program.Cagrilintide"The potential."

Novo Nordisk is studying Cagrilintide for overweight or obesity.Once-weekly subcutaneous injection treatment for obese adults, which will commence in the fourth quarter of 2025, is part of a dedicated Phase 3 trial.RENEW Program. Cagrilintide is a long-acting amylin analogue with a dosage of 2.4mg.

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