Testing NNC0487-0111 Against Semaglutide for Weight Loss in Type 2 Diabetes
Compares NNC0487-0111 with semaglutide in adults with excess weight and type 2 diabetes.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Bangkok and Khon Kaen, ThailandSee the 5 sites
- Phase
- Phase 3
Where in Thailand
- King Chulalongkorn Memorial Hospital_EndocrinologyBangkok, ThailandNo longer taking part
- Rajavithi Hospital_Diabetes and EndocrinologyBangkok, ThailandNo longer taking part
- Ramathibodi HospitalBangkok, ThailandNo longer taking part
- Siriraj HospitalBangkok, ThailandNo longer taking part
- Srinagarind HospitalKhon Kaen, ThailandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novo Nordisk A/S
- Trial code
- NCT07400107EU 2024-520446-31-00
- Record updated
- 10 November 2026
- Original description
The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and type 2 diabetes. Participant will receive 2 injections every week: an active medicine and a placebo, both taken as injections under the skin once a week. The placebo is a treatment with no active medicine in it and will be given to all participants. In addition to placebo, participants will receive either of the active medicine NNC0487-0111 (the treatment being tested) or Semaglutide (an approved and commonly prescribed treatment used as comparator). Which treatment participants get is decided by chance.Read full original descriptionShow less
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)
The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and type 2 diabetes. Participant will receive 2 injections every week: an active medicine and a placebo, both taken as injections under the skin once a week. The placebo is a treatment with no active medicine in it and will be given to all participants. In addition to placebo, participants will receive either of the active medicine NNC0487-0111 (the treatment being tested) or Semaglutide (an approved and commonly prescribed treatment used as comparator). Which treatment participants get is decided by chance.
Inclusion: Male or female (sex at birth); Age 18 years or above at the time of signing informed consent; Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening; Haemoglobin A1c (HbA1c) 7-10 percentage (%) (53-86 millimole per mole [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) before screening.
Exclusion: 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 before screening; Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 milliliter (mL)/ minute (min)/1.73 meter squared (m\^2) (2021 Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula), at screening; 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.