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AMAZE 2: Investigating NNC0487-0111 for Weight Loss in Type 2 Diabetes

This study, called AMAZE 2, is looking into whether a medicine called NNC0487-0111 is safe and effective for people who have excess body weight and type 2 diabetes. You would receive weekly injections under your skin, either NNC0487-0111 or a placebo (a treatment with no active medicine). The treatment you receive is chosen by chance. The main goal is to see how much your body weight changes over 84 weeks. To join, you must be at least 18 years old, have been diagnosed with type 2 diabetes for at least 180 days, and be on certain diabetes medications or lifestyle changes. The study plans to enroll about 630 participants.

Study design
This is an interventional study where participants are randomly assigned to receive either NNC0487-0111 or a placebo. It aims to enroll 630 participants.
What's involved
Participants will receive weekly subcutaneous injections in the thigh, abdomen, or upper arm. The primary endpoint is measured from week 0 to week 84.
Compensation
Not stated in the trial record.
Follow-up
Your body weight will be monitored for 84 weeks from the start of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07533175

AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight

Recruiting
PHASE3Ages 18+InterventionalTreatment
Novo Nordisk A/S
~630 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:NNC0487-0111Placebo (matched to NNC0487-0111)

At a glance

Recruiting sites
61 of 74 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

Diabetes Mellitus
Overweight
Obesity

Explore related trials

Diabetes MellitusObesityOverweight

Where it's being run

74 sites across 33 states
Croatia8
Hungary7
Romania7
Slovakia7
South Korea6
Florida4
California3
Argentina3

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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Do you actually qualify for this trial?

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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 more than equal to (≥) 180 days before 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.
Haemoglobin A1c (HbA1c) 7-10% \[53-86 (millimoles per mole) mmol/mol\] (both inclusive) as measured by the central laboratory at screening.

Exclusion

Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than (\<) 30 milliliter per minute per meter square (mL/min/1.73 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) before screening or are expected to require treatment 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 randomisation. 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.