CagriSema Outperforms Single-Component Therapy with Superior HbA1c Control in REIMAGINE 2 Study

Novo Nordisk recently announced significant findings from the REIMAGINE 2 clinical trial, demonstrating that CagriSema—a fixed-dose combination of two innovative drug components—achieved superior blood glucose control measured by HbA1c reduction compared to semaglutide alone. The trial results mark a notable advancement in diabetes and weight management therapy, with the combination treatment showing meaningful improvements across multiple endpoints in adults with type 2 diabetes.

Superior Clinical Outcomes: The HbA1c and Weight Loss Results

The REIMAGINE 2 study, which evaluated participants over a 68-week period, revealed that CagriSema delivered an HbA1c reduction of 1.91 percentage points alongside weight loss of 14.2%. More significantly, the combination therapy surpassed the efficacy of both individual components when tested separately. This dual benefit addresses a critical need in diabetes care, where managing blood sugar control while simultaneously reducing body weight represents a key therapeutic challenge. The trial data suggests that combining a GLP-1 receptor agonist (semaglutide) with an amylin receptor agonist (cagrilintide) produces synergistic effects that neither therapy alone can achieve.

Safety Profile and Treatment Approach

Throughout the trial period, CagriSema maintained a safe and well-tolerated profile consistent with similar hormone-based therapies in its class. The drug is being developed as a once-weekly subcutaneous injection, offering patients a convenient dosing schedule. Novo Nordisk is investigating the medication through two parallel programs: REIMAGINE for type 2 diabetes treatment and REDEFINE for weight management in individuals with overweight or obesity.

Regulatory Pathway and Future Development

Following promising results from earlier phase 3 trials (REIMAGINE 1 and REDEFINE 3), Novo Nordisk plans to engage with regulatory authorities to establish the clinical development pathway for CagriSema in type 2 diabetes. The company has already submitted a regulatory application to the US FDA in December 2025 for the weight management indication, based on data from REDEFINE 1 and REDEFINE 2 trials. Detailed findings from the REIMAGINE 2 trial are scheduled for presentation at a major scientific conference in 2026.

Clinical Perspective and Future Promise

Martin Holst Lange, executive vice president and chief scientific officer at Novo Nordisk, emphasized the significance of combining these two mechanisms: “By uniting semaglutide and cagrilintide, we’re witnessing superior outcomes in both blood glucose control and weight reduction that exceed what either therapy achieves individually. This combination could establish CagriSema as the first amylin-based treatment in its class and represents a promising therapeutic avenue for type 2 diabetes patients seeking comprehensive metabolic improvement.”

The development of CagriSema reflects a broader trend in diabetes care toward combination therapies that address multiple metabolic parameters simultaneously, potentially offering patients enhanced clinical benefits through synergistic pharmacological action.