Novo Nordisk has announced it has filed an NDA to FDA for CagriSema (cagrilintide), a once-weekly GLP-1 injection (to be used with a reduced-calorie diet and increased physical activity) to reduce excess body weight and maintain weight reduction long term in adults with obesity or are overweight in the presence of at least one weight-related comorbid condition.¹

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. If approved, CagriSema would mark the first injectable GLP-1 receptor agonist and amylin analogue combination treatment approved by FDA.¹

"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 robust 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," said Mike Doustdar, president and CEO of Novo Nordisk.

FDA is expected to review the NDA for CagriSema in 2026.¹

Why did Novo Nordisk decide to file an NDA for CagriSema?

Novo based its decision on results gathered from the Redefine 1, Phase III, randomized, double-blind, placebo-and-active-controlled clinical trial evaluating the efficiency and safety of CagriSema compared to semaglutide 2.4 mg alone, cagrilintide 2.4 mg alone, or placebo, as an adjunct to lifestyle intervention.¹

Redefine 1 spanned across 68 weeks and included 3,417 adult participants, without diabetes, with obesity or overweight and suffer from one or more obesity-related complications.

The Redefine 1 trial discovered that evaluation of the treatment effect of those treated with CagriSema reached weight loss upwards of 20.4%, from an average baseline body weight of 236 lb., at 68 weeks compared to 3.0%, from an average baseline body weight of 235 lb., for the placebo group which was statistically significant.¹ These results were consistent whether they stayed on treatment or not.

Patients administered with CagriSema resulted in greater weight loss at 68 weeks, reaching 22.7% versus 2.3% in the placebo group during evaluation of the treatment effect if all patients stayed on treatment.

Approximately 91.9% of participants taking CagriSema achieved a body weight reduction greater than or equal to 5%, compared to 31.5% for participants in the placebo group. In addition, a supportive secondary analysis discovered that around 54% of trial participants with obesity at baseline that were treated with CagriSema reached the threshold for non-obesity at week 68, where those in the placebo group reached a threshold of 11.1% at 68 weeks.¹

Novo Nordisk also held Redefine 2, a double-blind, randomized, placebo-controlled, 68-week, Phase III trial evaluating 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.¹

"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," said Doustdar. "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."

Sources

1. Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP‑1 and amylin analogues for weight management Novo Nordisk December 18, 2025 https://www.prnewswire.com/news-releases/novo-nordisk-files-for-fda-approval-of-cagrisema-the-first-once-weekly-combination-of-glp1-and-amylin-analogues-for-weight-management-302645862.html