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 ...