Efficacy and safety of NNC0487-0111 s.c. once-weekly compared to semaglutide s.c. once-weekly in participants with overweight or obesity, and type 2 diabetes (AMAZE 8)

Participants with overweight or obesity, and type 2 diabetes

Relative change in body weight

CCI, CCI, CCI, Change in haemoglobin A1c (HbA1c), Change in waist circumference, Change in systolic blood pressure (SBP):, Change in body weight, Change in body mass index (BMI), CCI, Achievement of HbA1c < 7.0% (Yes/No), Achievement of HbA1c ≤ 6.5% (Yes/No), Achievement of HbA1c < 5.7% (Yes/No), Change in fasting plasma glucose (FPG), Change in fasting insulin, Change in urinary albumin-to-creatinine ratio (UACR), Change in diastolic blood pressure (DBP), Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Triglycerides, Change in high-sensitivity C-reactive protein (hsCRP), Number of Treatment Emergent Adverse Events (TEAEs), Number of Treatment Emergent Serious Adverse Events (TESAEs), Number of TEAEs leading to permanent treatment discontinuation, Number of treatment-emergent clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L (54 mg/dL), confirmed by a blood glucose (BG) meter), Number of treatment-emergent severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold, Extension phase secondary endpoints are as follows; Change in body weight, Change in body mass index (BMI), Number of TEAEs, Number of TESAEs, Number of TEAEs leading to permanent treatment discontinuation, Number of treatment-emergent clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L (54 mg/dL), confirmed by BG meter), Number of treatment-emergent severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold

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