AMAZE 8: A research study investigating how well the medicine NNC0487-0111 compared to semaglutide helps people with excess body weight and type 2 diabetes lose weight

Prior treatment

• Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
• Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), or amylin analogues within CCI before screening.

Lab values

• Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m2 (2021 CKD-EPI formula), at screening.

Other

• Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire question 8.
• Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.

• Male or female (sex at birth)
• Age 18 years or above at the time of signing informed consent
• BMI ≥ CCI kg/m2 at screening
• CCI
• Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
• Haemoglobin A1c (HbA1c) 7-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening.
• Treatment with lifestyle intervention, and/or 0-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least CCI days before screening.