Denmark – Novo Nordisk unveiled strong new findings from a phase 3 trial for cagrilintide, their next-generation obesity medication. A dedicated new phase 3 clinical program is scheduled to start later this year after the results, which were presented at the European Association for the Study of Diabetes (EASD) congress, showed that the once-weekly amylin analogue produced significant, clinically meaningful weight loss in adults who were obese or overweight.
The monotherapy of cagrilintide was assessed in the REDEFINE 1 trial sub-analysis. The results demonstrated that over the course of 68 weeks, participants who received a 2.4 mg dose of cagrilintide together with a lifestyle intervention saw an average decrease in body weight of 11.8%. Assuming that every participant followed the treatment plan, the 2.3% weight loss seen in the placebo group stood in sharp contrast to this.
These results, which are the first and only phase 3 data for an experimental long-acting amylin analogue used as a stand-alone treatment for weight management, represent a significant milestone. Since cagrilintide acts via a different mechanism than the commonly utilized GLP-1-based therapies, it offers a new possible avenue for addressing the complicated condition of obesity. Amylin is a naturally occurring hormone.
Read More: Novo Nordisk’s Wegovy® (Semaglutide) Receives FDA Approval for MASH Treatment
The percentage of people who reached notable weight loss milestones further demonstrated the effectiveness of cagrilintide. Only 4.7% of people on a placebo dropped 15% or more of their body weight, compared to nearly one-third (31.6%) of those on cagrilintide.
It was discovered that cagrilintide was well tolerated in terms of safety. Gastrointestinal side effects, such as nausea, vomiting, diarrhea, and constipation, were the most commonly reported. The majority of these incidents were brief and mild to moderate in intensity. Remarkably, only 1.0% of patients on cagrilintide discontinued their therapy because of nausea, compared to 0.1% in the placebo group.
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.
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About the REDEFINE 1 trial
A 68-week efficacy and safety phase 3 trial called REDEFINE 1 compared the effects of once-weekly CagriSema (cagrilintide 2.4 mg and semaglutide 2.4 mg), cagrilintide 2.4 mg monotherapy, and semaglutide 2.4 mg monotherapy against placebo in 3,417 adults who were overweight (BMI ≥27 kg/m2), obese (BMI ≥30 kg/m2), and without type 2 diabetes. Over a period of 68 weeks, this post hoc investigation examined the safety and effectiveness of cagrilintide 2.4 mg used as a monotherapy in comparison to a placebo.
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