Novo Nordisk Files FDA Application For Dual Amylin–GLP-1 Obesity Therapy CagriSema; For Chronic Weight Management

Novo Nordisk has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for once-weekly CagriSema, a fixed-dose injectable combination of cagrilintide 2.4 mg, a long-acting amylin analogue, and semaglutide 2.4 mg, a GLP-1 receptor agonist. The therapy is intended for use alongside reduced-calorie diet and increased physical activity to support long-term weight reduction and weight maintenance in adults with obesity or overweight who have at least one weight-related comorbidity.

If approved, CagriSema would become the first injectable therapy combining a GLP-1 receptor agonist with an amylin analogue, representing a novel dual-hormone approach to obesity management.

“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.

The NDA submission is supported by data from two pivotal Phase 3 trials in the REDEFINE program. REDEFINE 1 was a 68-week, randomized, double-blind, placebo- and active-controlled trial evaluating CagriSema versus semaglutide alone, cagrilintide alone, or placebo in 3,417 adults without diabetes who had obesity or overweight with at least one obesity-related complication. REDEFINE 2 was a 68-week, randomized, double-blind, placebo-controlled trial assessing CagriSema in 1,206 adults with type 2 diabetes and obesity or overweight.

In REDEFINE 1, participants treated with CagriSema achieved a mean weight reduction of 20.4% at 68 weeks, compared with 3.0% for placebo, when assessed regardless of treatment discontinuation. In an analysis assuming all participants remained on therapy, weight loss reached 22.7% with CagriSema, versus 2.3% with placebo. Nearly 92% of participants receiving CagriSema achieved at least 5% body weight reduction, compared with 31.5% in the placebo group. A supportive analysis showed that 54% of participants with obesity at baseline reached a BMI below 30 kg/m², compared with 11.1% in the placebo arm.

“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.

Across REDEFINE 1 and 2, the safety profile of CagriSema was consistent with the established GLP-1 receptor agonist class. Discontinuations due to adverse events were low and comparable between treatment groups. The most commonly reported adverse events were gastrointestinal, including nausea, constipation, and vomiting, and were primarily mild to moderate in severity. The FDA is expected to review the CagriSema NDA in 2026.