Novo Nordisk: CagriSema outperforms tirzepatide 5 mg for weight loss

Topline efficacy results

In the phase 3 REIMAGINE 5 trial, once‑weekly CagriSema 1.0 mg/1.0 mg produced an estimated mean weight loss of 12.4% versus 9.1% for tirzepatide 5 mg at week 60, meeting superiority for weight change. The trial’s dual primary endpoints also showed a non‑inferior HbA1c reduction of 1.71% for CagriSema versus 1.67% for tirzepatide.

Obesity outcomes and safety

In REDEFINE 9, CagriSema 1.0 mg/1.0 mg delivered 21.0% weight loss versus 2.0% for placebo at week 68, meeting the primary superiority endpoint. CagriSema also produced greater improvements than placebo on prespecified supportive endpoints, including systolic blood pressure, waist‑to‑height ratio and fasting lipid profile. In both trials, CagriSema was reported to be well tolerated overall with a safety profile consistent with previous studies.

Trial populations, design and regulatory status

REIMAGINE 5 enrolled adults with type 2 diabetes inadequately controlled on metformin, an SGLT2 inhibitor, or both; dual primary endpoints were change in HbA1c and relative change in body weight to week 60. REDEFINE 9 tested CagriSema 1.7/1.7 mg and 1.0/1.0 mg versus placebo as an adjunct to diet and exercise, with primary endpoints at week 68. Novo reported these topline findings at its Capital Markets Day and noted it filed a New Drug Application for weight management in December 2025, with a U.S. FDA decision expected in Q4 2026; additional data on painful diabetic neuropathy were also previewed for later presentation.