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)

2024-520446-31-00 · tracked via the Priya Life Science EU tracker

Sponsor

Novo Nordisk A/S

Sponsor type

Pharmaceutical company

Therapeutic area

Nutritional and Metabolic Diseases

Decision date

15/05/2026

Enrollment target

440

Sites

Germany, Croatia, Portugal, Hungary, Bulgaria, Romania, Poland

Condition studied

Participants with overweight or obesity, and type 2 diabetes

Investigational medicinal product(s)

NNC0487-0111 B 10142NNC0487-0111 B 10143Wegovy 1.7 mg FlexTouch solution for injection in pre-filled penNNC0487-0111 B 10146Placebo NNC0487 0111 BNNC0487-0111 B 10144Wegovy 2.4 mg FlexTouch solution for injection in pre-filled penNNC0487-0111 B 10141NNC0487-0111 B 10145Placebo SemaglutideWegovy 1 mg FlexTouch solution for injection in pre-filled penWegovy 0.25 mg FlexTouch solution for injection in pre-filled penzenagamtide B 10176Wegovy 0.5 mg FlexTouch solution for injection in pre-filled pen

Eligibility

Age group

65+ years, 18-64 years

Sex

Female, Male

Primary endpoint

Relative change in body weight

Endpoint detail

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

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

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