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 now · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Overweight, Obesity

In brief

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. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Key facts

Study ID

NCT07533175

Run by

Novo Nordisk A/S

People needed

630

Starts

2026-04-13

Expected to finish

2028-08-07

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Alabama Birmingham — Birmingham, Alabama, United States (enrolling)
• Torrance Clinical Research Institute, Inc. — Lomita, California, United States (enrolling)
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States (enrolling)
• Northeast Research Institute — Fleming Island, Florida, United States (enrolling)
• Jacksonville Ctr Clin Res — Jacksonville, Florida, United States (enrolling)
• Florida Institute for Clinical Research, LLC — Orlando, Florida, United States (enrolling)
• Oviedo Medical Research, LLC — Oviedo, Florida, United States (enrolling)
• International Diabetes Center — Minneapolis, Minnesota, United States (enrolling)
• Southgate Medical Group, LLP — West Seneca, New York, United States (enrolling)
• Spartanburg Medical Research — Spartanburg, South Carolina, United States (enrolling)
• M3 Wake Research Chattanooga — Chattanooga, Tennessee, United States (enrolling)
• UT Southwestern Med Center — Dallas, Texas, United States (enrolling)
• PlanIt Research, PLLC — Houston, Texas, United States (enrolling)
• National Clin Res Inc. — Richmond, Virginia, United States (enrolling)
• MICA- Medicina e Investigación Cardiometabólica — Manuel Alberti, Buenos Aires, Argentina (enrolling)
• Kynet Recoleta — Buenos Aires, Argentina (enrolling)
• Centro médico privado Cemaic — Córdoba, Argentina (enrolling)
• CEDIR - Centro de diagnóstico y rehabilitación Santa Fe — Santa Fe, Argentina (enrolling)
• Cline Research Center — Curitiba, Paraná, Brazil (enrolling)
• PUCCAMP - Hospital e Maternidade Celso Pierro — Campinas, São Paulo, Brazil (enrolling)
• CPCLIN - Centro de Pesquisas Clínicas — São Paulo, São Paulo, Brazil (enrolling)
• Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USP — São Paulo, São Paulo, Brazil (enrolling)
• Opca bolnica Karlovac — Karlovac, Croatia (enrolling)
• Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology — Krapinske Toplice, Croatia (enrolling)
• Specijalna bolnica Thalassotherapia — Opatija, Croatia (enrolling)

Full record on ClinicalTrials.gov

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