Global pharma giant Novo Nordisk has submitted a New Drug Application to the US Food and Drug Administration seeking approval of once-weekly CagriSema, a fixed-dose injectable combination designed to help adults with obesity or overweight achieve and maintain long-term weight loss.

 

If cleared by regulators, CagriSema would become the first treatment to combine a GLP-1 receptor agonist and a long-acting amylin analogue in a single injection. The drug pairs semaglutide 2.4 mg with cagrilintide 2.4 mg and is intended for use alongside a reduced-calorie diet and increased physical activity in adults with obesity, or those who are overweight with at least one weight-related condition.

 

“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,” Doustdar added.

 

The application is supported by results from the phase 3 REDEFINE clinical program, including two 68-week trials enrolling more than 4,600 adults. REDEFINE 1 evaluated CagriSema in 3,417 adults with obesity or overweight without diabetes, comparing the combination therapy to semaglutide alone, cagrilintide alone, or placebo. REDEFINE 2 studied 1,206 adults with type 2 diabetes and obesity or overweight, comparing CagriSema with placebo.

 

In REDEFINE 1, patients treated with CagriSema achieved an average weight loss of 20.4% at 68 weeks when assessed regardless of treatment adherence, compared with 3.0% in the placebo group.

 

Across REDEFINE 1 and 2, safety findings were consistent with the GLP-1 receptor agonist class. Discontinuation rates due to adverse events were low, and the most common side effects were gastrointestinal, including nausea, constipation and vomiting.

 

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