CagriSema beats tirzepatide 5 mg on weight in REIMAGINE 5 and 21% weight loss in REDEFINE 9

Novo reported topline phase 3 results for CagriSema on 21 September 2026. In REIMAGINE 5, CagriSema 1.0 mg/1.0 mg produced superior weight loss versus tirzepatide 5 mg at week 60 and was non-inferior on HbA1c. In REDEFINE 9, CagriSema cut weight by 21.0% versus 2.0% for placebo at week 68, meeting its primary endpoint. The FDA decision on the new drug application filed in December 2025 is expected in the fourth quarter of 2026.

• REIMAGINE 5 at week 60: weight loss 12.4% vs 9.1% for tirzepatide 5 mg (superior)
• REIMAGINE 5 HbA1c drop 1.71% vs 1.67%, non-inferior
• REDEFINE 9 at week 68: weight loss 21.0% vs 2.0% for placebo, primary endpoint met
• FDA filing made in December 2025; decision expected in Q4 2026