Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema) 1.0 mg/1.0 mg s.c. once weekly versus tirzepatide 5 mg s.c. once weekly in participants with type 2 diabetes inadequately controlled on metformin, SGLT2 inhibitor or both

Type 2 Diabetes

Change in HbA1c from baseline (week 0) to end of treatment (week 60), Relative change in body weight from baseline (week 0) to end of treatment (week 60)

Superiority of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Change in HbA1c from baseline (week 0) to end of treatment (week 60), Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Change in FPG from baseline (week 0) to end of treatment (week 60), Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Achievement of HbA1c target values of ≤6.5% (≤48 mmol/mol) at the end of treatment (week 60), Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Achievement of HbA1c target values of <7.0% (<53 mmol/mol) at the end of treatment (week 60), Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Achievement of ≥ 10% weight reduction from baseline (week 0) to end of treatment (week 60), Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Achievement of ≥ 5% weight reduction from baseline (week 0) to end of treatment (week 60), Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Achievement of ≥ 15% weight reduction from baseline (week 0) to end of treatment (week 60), Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Achievement of ≥ 20% weight reduction from baseline (week 0) to end of treatment (week 60), Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Change in systolic blood pressure from baseline (week 0) to end of treatment (week 60), Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 60), Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Change in waist circumference from baseline (week 0) to end of treatment (week 60), Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Ratio to baseline in lipids from baseline (week 0) to end of treatment (week 60): • Total cholesterol • HDL cholesterol • LDL cholesterol • VLDL cholesterol • Triglycerides • Non-HDL cholesterol, Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Change in SF-36v2 score from baseline (week 0) to end of treatment (week 60): • Physical Component Summary score • Mental Component Summary score • Vitality subscale, Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Change in IWQOL-Lite-CT from baseline (week 0) to end of treatment (week 60): • Physical Function score • Total score, Safety and tolerability of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Number of TEAEs from baseline (week 0) to end of treatment (week 60), Safety and tolerability of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (<54 mg/dL), confirmed by BG meter) from baseline (week 0) to end of treatment (week 60), Safety and tolerability of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold from baseline (week 0) to end of treatment (week 60)

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