Actively Recruiting
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
Eligibility Criteria
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.
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
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
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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