NCT07533175RecruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Type 2 Diabetes (AMAZE 2)
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 630 (estimated)
- First submitted
- 9 Apr 2026
- Start date
- 13 Apr 2026
- Primary completion date
- 7 Aug 2028
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07533175
- EU CT number
- 2024-520441-23-00
- EudraCT number
- 2024-520441-23
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 630
- From 13 Apr 2026 to the primary completion date, 7 Aug 2028
- 70 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Lab values
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (70)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kynet Recoleta Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Centro Medico Privado CEMAIC Coordinator of this site? Confirm its status | Córdoba | Argentina | Recruiting |
| MICA- Medicina e Investigación Cardiometabólica Coordinator of this site? Confirm its status | Manuel Alberti | Argentina | Recruiting |
| CEDIR - Centro de diagnóstico y rehabilitación Santa Fe Coordinator of this site? Confirm its status | Santa Fe | Argentina | Recruiting |
| PUCCAMP - Hospital e Maternidade Celso Pierro Coordinator of this site? Confirm its status | Campinas | Brazil | Recruiting |
| Cline Research Center Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| CPCLIN - Centro de Pesquisas Clínicas Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USP Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Poliklinika Solmed d.o.o. Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Active, not recruiting |
| Opća bolnica Karlovac Coordinator of this site? Confirm its status | Karlovac | Croatia | Active, not recruiting |
| Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice Coordinator of this site? Confirm its status | Krapinske Toplice | Croatia | Active, not recruiting |
| Thalassotherapia Specijalna bolnica za medicinsku rehabilitaciju bolesti srca pluca i reumatizma Coordinator of this site? Confirm its status | Opatija | Croatia | Active, not recruiting |
| Poliklinika SLAVONIJA OSIJEK za opcu kirurgiju radiologiju baromedicinu ginekologiju i porodiljstvo i internu medicinu Coordinator of this site? Confirm its status | Osijek | Croatia | Active, not recruiting |
| Pula General Hospital Ospedale Generale di Pola Coordinator of this site? Confirm its status | Pula - Pola | Croatia | Active, not recruiting |
| Poliklinika za oftalmologiju optometriju i neurologiju Lux Coordinator of this site? Confirm its status | Solin | Croatia | Active, not recruiting |
| Opca Bolnica Varazdin Coordinator of this site? Confirm its status | Varazdin | Croatia | Active, not recruiting |
| DRC Kft. Coordinator of this site? Confirm its status | Balatonfüred | Hungary | Withdrawn |
| Szent Margit Rendelointezet Nonprofit Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Withdrawn |
| PVN Kutato Kft. Coordinator of this site? Confirm its status | Budapest X | Hungary | Withdrawn |
| Central Hospital Of Northern Pest Military Hospital Coordinator of this site? Confirm its status | Budapest XIII | Hungary | Withdrawn |
| Trantor 99 Bt. Coordinator of this site? Confirm its status | Budapest XXI | Hungary | Withdrawn |
| Somogy Vármegyei Kaposi Mór Oktató Kórház Coordinator of this site? Confirm its status | Kaposvár | Hungary | Withdrawn |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Withdrawn |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Chonnam National University Hospital_Endocrinology Coordinator of this site? Confirm its status | Gwangju | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System_Endocrinology Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Kyunghee University Medical Center_Endocrinology Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic University of Korea, Yeouido ST. Mary's Hospital_Endocrinology Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital_Endocrinology Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Asan Medical Center_Endocrinology Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Bundang Hospital_Endocrinology Coordinator of this site? Confirm its status | Seoungnam-si | South Korea | Recruiting |
| Clinstile S.A. de C.V. Coordinator of this site? Confirm its status | Col. Roma Norte | Mexico | Recruiting |
| Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab Coordinator of this site? Confirm its status | Distrito Federal | Mexico | Recruiting |
| Centro de Investigacion Clinica Endocrinologica de Jalisco Coordinator of this site? Confirm its status | Guadalajara | Mexico | Recruiting |
| Centro de Investigacion Clinica de Oaxaca (CICLO) Coordinator of this site? Confirm its status | Oaxaca City | Mexico | Recruiting |
| Consultorio de Endocrinología y Pediatría Coordinator of this site? Confirm its status | Puebla City | Mexico | Recruiting |
| Unidad Medica para la Salud Integral (UMSI) Coordinator of this site? Confirm its status | San Nicolás de los Garza | Mexico | Recruiting |
| Sc Cmi Dr. Pletea Noemi S.R.L. Coordinator of this site? Confirm its status | Bacau | Romania | Recruiting |
| Nutrilife S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Diabet Med S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Clinica Diabnutrimed S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Cmi Dr. Cojocaru Cristina Coordinator of this site? Confirm its status | Constanța | Romania | Recruiting |
| Top Diabet S.R.L. Coordinator of this site? Confirm its status | Craiova | Romania | Recruiting |
| Poli Cardinal Med S.R.L. Coordinator of this site? Confirm its status | Reghin | Romania | Recruiting |
| Spital Judetean De Urgenta Satu Mare Coordinator of this site? Confirm its status | Satu Mare | Romania | Recruiting |
| DIA - KONTROL s.r.o. Coordinator of this site? Confirm its status | Levice | Slovakia | Active, not recruiting |
| Narodny Endokrinologicky a diabetologicky ustav Coordinator of this site? Confirm its status | Ľubochňa | Slovakia | Active, not recruiting |
| OLIVER - MED s.r.o. Coordinator of this site? Confirm its status | Rimavská Sobota | Slovakia | Active, not recruiting |
| Peter Farkas MD, s.r.o. Coordinator of this site? Confirm its status | Šahy | Slovakia | Active, not recruiting |
| DEImedi, s. r. o. Coordinator of this site? Confirm its status | Šurany | Slovakia | Active, not recruiting |
| Areteus s.r.o. Coordinator of this site? Confirm its status | Trebišov | Slovakia | Active, not recruiting |
| Univ of Alabama Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| M3 Wake Research - Chattanooga Coordinator of this site? Confirm its status | Chattanooga | United States | Recruiting |
| UT Southwestern Med Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Headlands Research California, LLC Coordinator of this site? Confirm its status | Escondido | United States | Completed |
| Northeast Research Institute Coordinator of this site? Confirm its status | Fleming Island | United States | Recruiting |
| PlanIt Research, PLLC Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Jacksonville Ctr Clin Res Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Torrance Clinical Research Institute, Inc. Coordinator of this site? Confirm its status | Lomita | United States | Recruiting |
| International Diabetes Center Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Florida Institute For Clinical Research, LLC Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Oviedo Medical Research, LLC Coordinator of this site? Confirm its status | Oviedo | United States | Recruiting |
| National Clin Res Inc. Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Spartanburg Medical Research Coordinator of this site? Confirm its status | Spartanburg | United States | Recruiting |
| Diablo Clinical Research, Inc. Coordinator of this site? Confirm its status | Walnut Creek | United States | Recruiting |
| Southgate Medical Group, LLP Coordinator of this site? Confirm its status | West Seneca | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.