Novo Nordisk seeks USFDA approval for once weekly CagriSema for weight management

CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg, and the GLP-1 receptor agonist, semaglutide 2.4 mg.

“The FDA submission of CagriSema marks an important milestone and signals a new era in weight management, reinforcing Novo Nordisk’s long-standing commitment to serving people living with obesity through innovation and science. Building on the well-established profile of semaglutide and combining it with a novel mechanism of action, CagriSema has the potential to represent a meaningful step forward in the holistic treatment of obesity. With our leadership in metabolic disease, we are encouraged by the promise of this first-in-class combination to expand treatment options and address the evolving needs of patients,” said Mike Doustdar, president and CEO of Novo Nordisk.

“This submission reflects the continued advancement of Novo Nordisk’s obesity pipeline and our focus on translating scientific innovation into patient-relevant outcomes. If approved, CagriSema would provide patients and healthcare professionals with an additional treatment option supported by results from the REDEFINE clinical program, including powerful efficacy, high treatment completion rates, and a tolerability profile consistent with its underlying pharmacology. We believe these data underscore the potential of CagriSema to address unmet medical needs in obesity and support long-term disease management,” added Mike Doustdar.

The NDA is based on results from REDEFINE 1, a 68-week, phase 3, randomized, double-blind, placebo-and active-controlled trial that evaluated the efficacy and safety of once-weekly, CagriSema compared to semaglutide 2.4 mg alone, cagrilintide 2.4 mg alone, or placebo, all as an adjunct to lifestyle intervention in 3,417 adults with obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) with one or more obesity-related complications and without diabetes, and REDEFINE 2, a double-blind, randomized, placebo-controlled, 68-week, phase 3 trial that evaluated the efficacy and safety of once-weekly CagriSema versus placebo, as an adjunct to lifestyle intervention in 1,206 adults with type 2 diabetes and either obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2).

The REDEFINE 1 trial found that when evaluating the treatment effect regardless of whether patients stayed on treatment, those treated with CagriSema achieved weight loss of 20.4% (from an average baseline body weight of 236 lb) at 68 weeks versus 3.0% (from an average baseline body weight of 235 lb) for the placebo group which was statistically significant. CagriSema resulted in greater weight loss of 22.7% at 68 weeks versus 2.3% in the placebo group when evaluating the treatment effect if all patients stayed on treatment. 91.9% of participants taking CagriSema achieved a body weight reduction of greater than or equal to 5%, compared to 31.5% for the placebo group. In addition, a supportive secondary analysis showed that about half (54%) of trial participants with obesity at baseline treated with CagriSema reached the threshold for non-obesity (BMI <30 kg/m2) at week 68. In the placebo group, 11.1% reached that threshold at 68 weeks.

Safety data generated in the REDEFINE 1 and 2 trials was comparable with the GLP-1 RA class. 

The FDA is expected to review the CagriSema application in 2026.