Novo Nordisk A/S (NYSE:NVO) on Monday shared headline results from the REIMAGINE 2 phase 3 trial from the global REIMAGINE clinical trial program.
CagriSema for weight management was submitted to the U.S. Food and Drug Administration (FDA) in December 2025 based on the REDEFINE 1 and REDEFINE 2 pivotal trials.
Trial Data
REIMAGINE 2 was a 68-week efficacy and safety trial investigating once-weekly subcutaneous CagriSema (a fixed dose combination of cagrilintide and semaglutide) in two different doses (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) compared to two different doses of semaglutide (2.4 mg and 1.0 mg), cagrilintide (2.4 mg), and placebo.
The trial included 2,728 people with type 2 diabetes inadequately controlled with metformin with or without an SGLT2 inhibitor. Approximately 40% of all people were using an SGLT2 inhibitor before initiating the trial.
CagriSema demonstrated higher HbA1c reduction and weight loss at week 68 versus semaglutide, across all tested doses in the trial.
When evaluating the effects of treatment, from a mean HbA1c baseline of 8.2%, people treated with CagriSema 2.4 mg/2.4 mg achieved a HbA1c reduction of 1.91%-points after 68 weeks compared to 1.76%-points with semaglutide 2.4 mg.
From a mean baseline body weight of 101 kg, people treated with CagriSema 2.4 mg/2.4 mg achieved weight loss of 14.2% after 68 weeks compared to 10.2% with semaglutide 2.4 mg.
No weight loss plateau was observed at week 68 for CagriSema. With CagriSema 2.4 mg/2.4 mg, 43% of the people achieved ≥15% weight loss, and 24% achieved ≥20% weight loss.
When applying the treatment regimen estimand, people treated with CagriSema 2.4 mg/2.4 mg achieved a HbA1c reduction of 1.80%-points after 68 weeks compared to 1.68%-points with semaglutide 2.4 mg. In addition, people treated with CagriSema 2.4 mg/2.4 mg achieved weight loss of 12.9% after 68 weeks compared to 9.2% with semaglutide 2.4 mg.
In the trial, CagriSema appeared to have a safe and well-tolerated profile. The most common adverse events with CagriSema were gastrointestinal, and the vast majority were mild to moderate and diminished over time, consistent with incretin and amylin-based therapies.
NVO Price Action: Novo Nordisk shares were down 0.61% at $59.07 at the time of publication on Monday, according to Benzinga Pro data.
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