Actively Recruiting

Phase 3
Age: 18Years +
All Genders
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

Led by Novo Nordisk A/S · Updated on 2026-04-27

630

Participants Needed

73

Research Sites

121 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female (sex at birth).
  • Age 18 years or above at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus at least 180 days before screening.
  • Treated with lifestyle intervention and/or 0-3 marketed oral antidiabetic drugs (metformin, alpha-glucosidase inhibitors, glinides, SGLT2 inhibitors, thiazolidinediones, or sulfonylureas) as single agents or in combination.
  • Oral antidiabetic drug treatment must be stable in drug, dose, and frequency before screening.
  • Haemoglobin A1c (HbA1c) between 7% and 10% [53-86 mmol/mol] inclusive as measured at screening.
Not Eligible

You will not qualify if you...

  • Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 mL/min/1.73 m² at screening.
  • Diabetic retinopathy or maculopathy treated with retinal photocoagulation, vitrectomy, or anti-VEGF before screening or expected to require treatment after screening.
  • Diabetic retinopathy or maculopathy must be verified by an eye exam within 90 days before screening or between screening and randomisation with pharmacological pupil-dilation unless using approved non-dilated digital fundus photography.
  • Known hypoglycaemic unawareness as indicated by Clarke's questionnaire question 8.
  • Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
  • Treatment with GLP-1 receptor agonists, dual GLP-1/GIP receptor agonists, or amylin analogues before screening.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 73 locations

1

Univ of Alabama Birmingham

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

Headlands Research California, LLC

Escondido, California, United States, 92025

Actively Recruiting

3

Torrance Clinical Research Institute, Inc.

Lomita, California, United States, 90717

Actively Recruiting

4

Diablo Clinical Research, Inc.

Walnut Creek, California, United States, 94598

Actively Recruiting

5

Northeast Research Institute

Fleming Island, Florida, United States, 32003

Actively Recruiting

6

Jacksonville Ctr Clin Res

Jacksonville, Florida, United States, 32216

Actively Recruiting

7

Florida Institute for Clinical Research, LLC

Orlando, Florida, United States, 32825

Actively Recruiting

8

Oviedo Medical Research, LLC

Oviedo, Florida, United States, 32765

Actively Recruiting

9

International Diabetes Center

Minneapolis, Minnesota, United States, 55416

Actively Recruiting

10

Southgate Medical Group, LLP

West Seneca, New York, United States, 14224

Actively Recruiting

11

Spartanburg Medical Research

Spartanburg, South Carolina, United States, 29303

Actively Recruiting

12

M3 Wake Research Chattanooga

Chattanooga, Tennessee, United States, 37421

Actively Recruiting

13

UT Southwestern Medical Center - Lingvay

Dallas, Texas, United States, 75390

Actively Recruiting

14

PlanIt Research, PLLC

Houston, Texas, United States, 77079

Actively Recruiting

15

National Clin Res Inc.

Richmond, Virginia, United States, 23294

Actively Recruiting

16

MICA- Medicina e Investigación Cardiometabólica

Manuel Alberti, Buenos Aires, Argentina, B1669

Not Yet Recruiting

17

Kynet Recoleta

Buenos Aires, Argentina, C1119ACU

Not Yet Recruiting

18

Centro médico privado Cemaic

Córdoba, Argentina, X5008

Not Yet Recruiting

19

CEDIR - Centro de diagnóstico y rehabilitación Santa Fe

Santa Fe, Argentina, S3000FSO

Not Yet Recruiting

20

Cline Research Center

Curitiba, Paraná, Brazil, 80030-480

Not Yet Recruiting

21

PUCCAMP - Hospital e Maternidade Celso Pierro

Campinas, São Paulo, Brazil, 13060-803

Not Yet Recruiting

22

CPCLIN - Centro de Pesquisas Clínicas

São Paulo, São Paulo, Brazil, 01228-200

Not Yet Recruiting

23

Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, Brazil, 05403-000

Not Yet Recruiting

24

Opca bolnica Karlovac

Karlovac, Croatia, 47000

Not Yet Recruiting

25

Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology

Krapinske Toplice, Croatia, 49217

Not Yet Recruiting

26

Specijalna bolnica Thalassotherapia

Opatija, Croatia, 51 410

Not Yet Recruiting

27

Poliklinika SLAVONIJA OSIJEK

Osijek, Croatia, 31000

Not Yet Recruiting

28

Opca bolnica Pula

Pula, Croatia, 52100

Not Yet Recruiting

29

Poliklinika za oftalmologiju optometriju i neurologiju Lux

Solin, Croatia, 21210

Not Yet Recruiting

30

Opca bolnica Varazdin_Endocrinology

Varaždin, Croatia, 42 000

Not Yet Recruiting

31

Poliklinika Solmed

Zagreb, Croatia, 10000

Not Yet Recruiting

32

Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ

Szeged, Csongrád-Csanád, Hungary, 6725

Not Yet Recruiting

33

DRC Kft.

Balatonfüred, Hungary, 8230

Not Yet Recruiting

34

Szent Margit Rendelőintézet Nonprofit Kft.

Budapest, Hungary, 1032

Not Yet Recruiting

35

Semmelweis Egyetem

Budapest, Hungary, 1083

Withdrawn

36

PVN Kutató Kft.

Budapest, Hungary, 1102

Not Yet Recruiting

37

Észak-Pesti Centrumkórház Honvédkórház - Diabetológia Szakrendelés

Budapest, Hungary, 1134

Not Yet Recruiting

38

Trantor 99 Bt

Budapest, Hungary, H-1213

Not Yet Recruiting

39

Somogy Vármegyei Kaposi Mór Oktató Kórház

Kaposvár, Hungary, 7400

Not Yet Recruiting

40

Dip. Med. Chir. delle malattie digestive, epatiche ed endo-meta - UOC Endocrinologia e prevenzione e cura del diabete

Bologna, Emilia-Romagna, Italy, 40138

Not Yet Recruiting

41

Universita Degli Studi Di Roma La Sapienza - Policlinico Umberto I Medicina Sperimentale

Rome, Lazio, Italy, 00161

Not Yet Recruiting

42

Grande Ospedale Metropolitano Niguarda - Dipartimento Medico Polispecialistico - Diabetologia

Milan, Lombardy, Italy, 20159

Not Yet Recruiting

43

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - PSD Nutrizione Clinica, Obesità e Metabolismo

Palermo, Sicily, Italy, 90127

Not Yet Recruiting

44

IRCCS Ospedale San Raffaele Milano

Milan, Italy, 20132

Not Yet Recruiting

45

Dip. di Medicina Interna Policlinico Universitario Palermo

Palermo, Italy, 90127

Not Yet Recruiting

46

Centro de Investigacion Clinica Endocrinologica de Jalisco

Guadalajara, Jalisco, Mexico, 44670

Not Yet Recruiting

47

Clinstile S.A. de C.V.

Col Roma Norte, Mexico City, Mexico, 06700

Not Yet Recruiting

48

Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab

Distrito Federal, México, D.F., Mexico, 14080

Not Yet Recruiting

49

Unidad Medica para la Salud Integral (UMSI)

San Nicolás de los Garza, Nuevo León, Mexico, 66465

Not Yet Recruiting

50

Centro de Investigación Clinica de Oaxaca (CICLO)

Oaxaca City, Oaxaca, Mexico, 68020

Not Yet Recruiting

51

Consultorio de Endocrinología y Pediatría

Puebla City, Mexico, 72190

Not Yet Recruiting

52

S.C. Top Diabet Srl

Craiova, Dolj, Romania, 200515

Not Yet Recruiting

53

Poli Cardinal Med Srl

Reghin, Mureș County, Romania, 545300

Not Yet Recruiting

54

CMI Dr. Pletea Noemi SRL

Bacau, Romania, 600154

Not Yet Recruiting

55

SC Nutrilife SRL

Bucharest, Romania, 013764

Not Yet Recruiting

56

SC Clinica Diabnutrimed S.R.L.

Bucharest, Romania, 020359

Not Yet Recruiting

57

Diabet Med SRL

Bucharest, Romania, 050913

Not Yet Recruiting

58

Cmi Dr. Cojocaru Cristina

Constanța, Romania, 900512

Not Yet Recruiting

59

A&C Medical Prime S.R.L.

Craiova, Romania, 200692

Not Yet Recruiting

60

Spital Judetean De Urgenta Satu Mare

Satu Mare, Romania, 440055

Not Yet Recruiting

61

DIA - KONTROL s.r.o.

Levice, Slovakia, 93401

Not Yet Recruiting

62

Narodny Endokrinologicky a diabetologicky ustav

Ľubochňa, Slovakia, 03491

Not Yet Recruiting

63

OLIVER - MED s.r.o.

Rimavská Sobota, Slovakia, 979 01

Not Yet Recruiting

64

Peter Farkas MD, s.r.o.

Šahy, Slovakia, 93601

Not Yet Recruiting

65

DEImedi, s. r. o.

Šurany, Slovakia, 942 01

Not Yet Recruiting

66

ARETEUS s.r.o.

Trebišov, Slovakia, 075 01

Not Yet Recruiting

67

Seoul National University Bundang Hospital_Endocrinology

Seoungnam-si, Gyeonggi-do, South Korea, 13620

Not Yet Recruiting

68

Chonnam National University Hospital_Endocrinology

Gwangju, South Korea, 61469

Not Yet Recruiting

69

Kyunghee University Medical Center_Endocrinology

Seoul, South Korea, 02447

Not Yet Recruiting

70

Seoul National University Hospital_Endocrinology

Seoul, South Korea, 03080

Not Yet Recruiting

71

Severance Hospital, Yonsei University Health System_Endocrinology

Seoul, South Korea, 03722

Not Yet Recruiting

72

Asan Medical Center_Endocrinology

Seoul, South Korea, 05505

Not Yet Recruiting

73

The Catholic University of Korea, Yeouido ST. Mary's Hospital_Endocrinology

Seoul, South Korea, 07345

Not Yet Recruiting

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Research Team

N

Novo Nordisk

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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