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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
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

Full criteria on ClinicalTrials.gov

Sites (70)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kynet Recoleta
Coordinator of this site? Confirm its status
Buenos AiresArgentinaRecruiting
Centro Medico Privado CEMAIC
Coordinator of this site? Confirm its status
CórdobaArgentinaRecruiting
MICA- Medicina e Investigación Cardiometabólica
Coordinator of this site? Confirm its status
Manuel AlbertiArgentinaRecruiting
CEDIR - Centro de diagnóstico y rehabilitación Santa Fe
Coordinator of this site? Confirm its status
Santa FeArgentinaRecruiting
PUCCAMP - Hospital e Maternidade Celso Pierro
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CampinasBrazilRecruiting
Cline Research Center
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CuritibaBrazilRecruiting
CPCLIN - Centro de Pesquisas Clínicas
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São PauloBrazilRecruiting
Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USP
Coordinator of this site? Confirm its status
São PauloBrazilRecruiting
Poliklinika Solmed d.o.o.
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Grad ZagrebCroatiaActive, not recruiting
Opća bolnica Karlovac
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KarlovacCroatiaActive, not recruiting
Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice
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Krapinske TopliceCroatiaActive, not recruiting
Thalassotherapia Specijalna bolnica za medicinsku rehabilitaciju bolesti srca pluca i reumatizma
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OpatijaCroatiaActive, not recruiting
Poliklinika SLAVONIJA OSIJEK za opcu kirurgiju radiologiju baromedicinu ginekologiju i porodiljstvo i internu medicinu
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OsijekCroatiaActive, not recruiting
Pula General Hospital Ospedale Generale di Pola
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Pula - PolaCroatiaActive, not recruiting
Poliklinika za oftalmologiju optometriju i neurologiju Lux
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SolinCroatiaActive, not recruiting
Opca Bolnica Varazdin
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VarazdinCroatiaActive, not recruiting
DRC Kft.
Coordinator of this site? Confirm its status
BalatonfüredHungaryWithdrawn
Szent Margit Rendelointezet Nonprofit Kft.
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Budapest IIIHungaryWithdrawn
PVN Kutato Kft.
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Budapest XHungaryWithdrawn
Central Hospital Of Northern Pest Military Hospital
Coordinator of this site? Confirm its status
Budapest XIIIHungaryWithdrawn
Trantor 99 Bt.
Coordinator of this site? Confirm its status
Budapest XXIHungaryWithdrawn
Somogy Vármegyei Kaposi Mór Oktató Kórház
Coordinator of this site? Confirm its status
KaposvárHungaryWithdrawn
University of Szeged
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SzegedHungaryWithdrawn
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
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PalermoItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyRecruiting
Chonnam National University Hospital_Endocrinology
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GwangjuSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System_Endocrinology
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Kyunghee University Medical Center_Endocrinology
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
The Catholic University of Korea, Yeouido ST. Mary's Hospital_Endocrinology
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Seoul National University Hospital_Endocrinology
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SeoulSouth KoreaRecruiting
Asan Medical Center_Endocrinology
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Seoul National University Bundang Hospital_Endocrinology
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Seoungnam-siSouth KoreaRecruiting
Clinstile S.A. de C.V.
Coordinator of this site? Confirm its status
Col. Roma NorteMexicoRecruiting
Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab
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Distrito FederalMexicoRecruiting
Centro de Investigacion Clinica Endocrinologica de Jalisco
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GuadalajaraMexicoRecruiting
Centro de Investigacion Clinica de Oaxaca (CICLO)
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Oaxaca CityMexicoRecruiting
Consultorio de Endocrinología y Pediatría
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Puebla CityMexicoRecruiting
Unidad Medica para la Salud Integral (UMSI)
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San Nicolás de los GarzaMexicoRecruiting
Sc Cmi Dr. Pletea Noemi S.R.L.
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BacauRomaniaRecruiting
Nutrilife S.R.L.
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BucharestRomaniaRecruiting
Diabet Med S.R.L.
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BucharestRomaniaRecruiting
Clinica Diabnutrimed S.R.L.
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BucharestRomaniaRecruiting
Cmi Dr. Cojocaru Cristina
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ConstanțaRomaniaRecruiting
Top Diabet S.R.L.
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CraiovaRomaniaRecruiting
Poli Cardinal Med S.R.L.
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ReghinRomaniaRecruiting
Spital Judetean De Urgenta Satu Mare
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Satu MareRomaniaRecruiting
DIA - KONTROL s.r.o.
Coordinator of this site? Confirm its status
LeviceSlovakiaActive, not recruiting
Narodny Endokrinologicky a diabetologicky ustav
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ĽubochňaSlovakiaActive, not recruiting
OLIVER - MED s.r.o.
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Rimavská SobotaSlovakiaActive, not recruiting
Peter Farkas MD, s.r.o.
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ŠahySlovakiaActive, not recruiting
DEImedi, s. r. o.
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ŠuranySlovakiaActive, not recruiting
Areteus s.r.o.
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TrebišovSlovakiaActive, not recruiting
Univ of Alabama Birmingham
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BirminghamUnited StatesRecruiting
M3 Wake Research - Chattanooga
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ChattanoogaUnited StatesRecruiting
UT Southwestern Med Center
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DallasUnited StatesRecruiting
Headlands Research California, LLC
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EscondidoUnited StatesCompleted
Northeast Research Institute
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Fleming IslandUnited StatesRecruiting
PlanIt Research, PLLC
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HoustonUnited StatesRecruiting
Jacksonville Ctr Clin Res
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JacksonvilleUnited StatesRecruiting
Torrance Clinical Research Institute, Inc.
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LomitaUnited StatesRecruiting
International Diabetes Center
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MinneapolisUnited StatesRecruiting
Florida Institute For Clinical Research, LLC
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OrlandoUnited StatesRecruiting
Oviedo Medical Research, LLC
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OviedoUnited StatesRecruiting
National Clin Res Inc.
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RichmondUnited StatesRecruiting
Spartanburg Medical Research
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SpartanburgUnited StatesRecruiting
Diablo Clinical Research, Inc.
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Walnut CreekUnited StatesRecruiting
Southgate Medical Group, LLP
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West SenecaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.