Novo Nordisk Reveals Headline Phase III Trial Results Evaluating Combination Obesity Treatment
The company’s fixed-dose combination treatment demonstrated superior efficacy to its individual components and was shown to be safe and well-tolerated, consisted with other incretin and amylin-based therapies.
Global healthcare company, Novo Nordisk, has announced the headline results from the Phase III trial, REIMAGINE 2, which has been designed to evaluate the efficacy and safety of its fixed-dose combination treatment for obesity, CagriSema. The trial results were announced by Novo Nordisk in a Feb. 2, 2026 press release (1).
The fixed-dose treatment, CagriSema, comprises a combination of the amylin receptor agonist, Cagrilintide, and the GLP-1 receptor agonist, semaglutide. In the Phase III trial, the fixed-dose treatment was compared to two different doses of semaglutide, cagrilintide, and placebo in a cohort of 2,728 patients with type 2 diabetes inadequately controlled with metformin, either with or without an SGLT2 inhibitor.
According to the trial results, announced by Novo Nordisk, the 2.4 mg/2.4 mg fixed-combination treatment demonstrated superior HbA1c reduction and weight loss compared to semaglutide 2.4 mg after a period of 68 weeks. Additionally, the fixed-dose combination treatment demonstrated a safe and well-tolerated profile. With the vast majority of adverse events being mild to moderate and diminishing over time (1).
“We are very pleased by the clinical profile of CagriSema in type 2 diabetes patients, including a confirmation of the very strong weight loss data seen with CagriSema in the obesity trials,” said Martin Holst Lange, Executive Vice President, Chief Scientific Officer and Head of Research and Development at Novo Nordisk, in the company press release (1). “By combining semaglutide and cagrilintide, we're seeing superior outcomes in both blood glucose control and weight reduction beyond those achieved with each therapy individually. The results strengthen our belief that CagriSema could be the first amylin-based combination therapy and a promising treatment option for individuals with type 2 diabetes, who also has a focus on weight loss.”
Novo Nordisk has already applied for FDA approval of its fixed-dose combination treatment in December 2025 as a once weekly injection for weight management in adults (2). If approved by the U.S. regulatory authority, CagriSema will become the first injectable combination treatment to include a GLP-1 receptor agonist and amylin analogue.
“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,” explained Mike Doustdar, President and CEO of Novo Nordisk, in a company press release about the regulatory submission (2).” 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.”
References
Novo Nordisk. Novo Nordisk A/S: CagriSema Demonstrated Superior HbA1c Reduction of 1.91%-Points and Weight Loss of 14.2% in Adults with Type 2 Diabetes in the REIMAGINE 2 Trial. Press Release, Feb. 2, 2026.
Novo Nordisk. Novo Nordisk Files for FDA Approval of CagriSema, the First Once-Weekly Combination of GLP-1 and Amylin Analogues for Weight Management. Press Release, Dec. 18, 2025.