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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 3

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

985 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

• 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.
• 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.
• 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.
• 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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Quadruple masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (122)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

122 locations

Study team and timeline

Lead sponsor

Novo Nordisk A/S

Study start

May 20, 2026 Actual

Primary completion

Dec 19, 2028 Estimated

Study completion

Dec 19, 2028 Estimated

First posted

Feb 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.