Novo Nordisk A/S has released headline outcomes from its REIMAGINE 2 clinical trial, demonstrating that CagriSema—a fixed-dose combination of cagrilintide and semaglutide—delivers superior blood glucose management compared to semaglutide alone. The trial results show that CagriSema achieved an HbA1c reduction of 1.91 percentage points at the 68-week mark, alongside a notable body weight reduction of 14.2%, establishing clear advantages across both efficacy measures against individual components.
Breakthrough Results from REIMAGINE 2 Trial
The REIMAGINE 2 efficacy and safety trial represents a pivotal phase 3 evaluation of once-weekly subcutaneous CagriSema in adults with type 2 diabetes. The combination therapy demonstrated superiority on HbA1c lowering and weight management across all dose levels tested, with a consistent and favorable safety profile aligned with incretin-based and amylin-based treatment mechanisms. These findings reinforce the potential of dual-mechanism therapies in addressing the complex metabolic needs of patients requiring both glucose control and weight reduction.
The trial design compared CagriSema against semaglutide monotherapy, with results confirming that the amylin component enhances the glucose-lowering efficacy of the GLP-1 receptor agonist. This synergistic effect on HbA1c reduction positions CagriSema as a differentiated treatment option within the diabetes management landscape.
Clinical Significance and Development Progress
Martin Holst Lange, executive vice president and chief scientific officer at Novo Nordisk, emphasized that “combining semaglutide and cagrilintide delivers superior outcomes in both blood glucose control and weight reduction beyond those achieved individually. The results support our vision that CagriSema could represent the first amylin-based combination therapy for type 2 diabetes, offering meaningful benefits to patients prioritizing HbA1c control alongside weight management.”
The company is simultaneously investigating CagriSema through its REDEFINE programme for adults with overweight or obesity, expanding the therapeutic applications of this dual-mechanism approach. CagriSema for weight management received FDA submission in December 2025 based on pivotal REDEFINE 1 and REDEFINE 2 trial outcomes, accelerating the regulatory timeline.
Regulatory Pathway and Market Outlook
Following positive outcomes from REIMAGINE 1 and REDEFINE 3, Novo Nordisk plans to engage with regulatory authorities to establish the development pathway for CagriSema in type 2 diabetes. Detailed results from REIMAGINE 2 are scheduled for presentation at a major scientific conference in 2026, providing the clinical community with comprehensive efficacy and safety data.
In trading activity, Novo Nordisk shares reflected modest market response, closing Monday’s session down 0.8% at $58.93, though overnight trading showed recovery with shares gaining approximately 0.4% to $59.19 on the NYSE.
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CagriSema Combination Therapy Achieves Superior HbA1c Control in Type 2 Diabetes Trial
Novo Nordisk A/S has released headline outcomes from its REIMAGINE 2 clinical trial, demonstrating that CagriSema—a fixed-dose combination of cagrilintide and semaglutide—delivers superior blood glucose management compared to semaglutide alone. The trial results show that CagriSema achieved an HbA1c reduction of 1.91 percentage points at the 68-week mark, alongside a notable body weight reduction of 14.2%, establishing clear advantages across both efficacy measures against individual components.
Breakthrough Results from REIMAGINE 2 Trial
The REIMAGINE 2 efficacy and safety trial represents a pivotal phase 3 evaluation of once-weekly subcutaneous CagriSema in adults with type 2 diabetes. The combination therapy demonstrated superiority on HbA1c lowering and weight management across all dose levels tested, with a consistent and favorable safety profile aligned with incretin-based and amylin-based treatment mechanisms. These findings reinforce the potential of dual-mechanism therapies in addressing the complex metabolic needs of patients requiring both glucose control and weight reduction.
The trial design compared CagriSema against semaglutide monotherapy, with results confirming that the amylin component enhances the glucose-lowering efficacy of the GLP-1 receptor agonist. This synergistic effect on HbA1c reduction positions CagriSema as a differentiated treatment option within the diabetes management landscape.
Clinical Significance and Development Progress
Martin Holst Lange, executive vice president and chief scientific officer at Novo Nordisk, emphasized that “combining semaglutide and cagrilintide delivers superior outcomes in both blood glucose control and weight reduction beyond those achieved individually. The results support our vision that CagriSema could represent the first amylin-based combination therapy for type 2 diabetes, offering meaningful benefits to patients prioritizing HbA1c control alongside weight management.”
The company is simultaneously investigating CagriSema through its REDEFINE programme for adults with overweight or obesity, expanding the therapeutic applications of this dual-mechanism approach. CagriSema for weight management received FDA submission in December 2025 based on pivotal REDEFINE 1 and REDEFINE 2 trial outcomes, accelerating the regulatory timeline.
Regulatory Pathway and Market Outlook
Following positive outcomes from REIMAGINE 1 and REDEFINE 3, Novo Nordisk plans to engage with regulatory authorities to establish the development pathway for CagriSema in type 2 diabetes. Detailed results from REIMAGINE 2 are scheduled for presentation at a major scientific conference in 2026, providing the clinical community with comprehensive efficacy and safety data.
In trading activity, Novo Nordisk shares reflected modest market response, closing Monday’s session down 0.8% at $58.93, though overnight trading showed recovery with shares gaining approximately 0.4% to $59.19 on the NYSE.