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AMAZE 8: Weight Loss Study for Type 2 Diabetes

This study, AMAZE 8, is looking at how well a medicine called NNC0487-0111 helps people with excess body weight and type 2 diabetes lose weight, compared to an approved medicine called semaglutide. You would receive two injections under the skin each week: one active medicine (either NNC0487-0111 or semaglutide) and one placebo (a treatment with no active medicine). The main goal is to see how much body weight changes over 84 weeks. To join, you need to be at least 18 years old, have been diagnosed with type 2 diabetes for at least 180 days, and have a specific HbA1c (a measure of blood sugar) level between 7% and 10%.

Study design
This is an interventional study comparing NNC0487-0111 to semaglutide, with participants randomly assigned to receive one of the active medicines plus a placebo. The study plans to enroll 1000 participants.
What's involved
You would receive two injections under the skin each week. The primary endpoint for measuring body weight change is from baseline to week 84.
Compensation
Not stated in the trial record.
Follow-up
Body weight will be measured from the start of the study (week 0) to week 84.

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NCT07400107

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

Not Yet Recruiting
PHASE3Ages 18+InterventionalTreatment
Novo Nordisk A/S
~1,000 participants
Updated 2026-03-12 on ClinicalTrials.gov
What's tested:NNC0487-0111SemaglutidePlacebo (matched to NNC0487-0111)Placebo (matched to semaglutide)

At a glance

Recruiting sites
0 of 120 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Relative change in body weight
Measured over From baseline (week 0) to week 84

Conditions

Obesity
Overweight
Diabetes Mellitus, Type 2

Explore related trials

ObesityOverweightType 2 Diabetes Mellitus

Where it's being run

120 sites across 44 states
Poland16
Bulgaria11
Germany10
Croatia8
Portugal8
Turkey (Türkiye)7
Romania6
Thailand5

Study leadership

  • Clinical Transparency (dept. 2834) · STUDY_DIRECTOR · Novo Nordisk A/S

Who to contact

Novo Nordisk
[email protected]
(+1) 866-867-7178
Email the study team

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Eligibility criteria

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

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.

What this trial measures

  • Relative change in body weightFrom baseline (week 0) to week 84

    Measured as percentage of body weight.