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1,315,316 Although there were no head-to-head RCTs comparing GLP-1 and SGLT-is for cardiovascular benefit, a meta-analysis showed no significant difference between them

See our July 2026 FDA action analysis and 503A vs 503B guide

Following the positive REDEFINE 1 Phase 3 data (published June 2025, PMID: 40544433), Novo Nordisk announced plans to file regulatory applications for CagriSema for obesity in the United States (FDA), European Union (EMA), and other major markets in 20252026

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