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NCT07533175PHASE3Recruiting

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

Novo Nordisk A/S

Start Date

4/13/2026

Completion Date

8/7/2028

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Interventions

DRUG

NNC0487-0111

DRUG

Placebo (matched to NNC0487-0111)

Interested in This Trial?

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Conditions

Diabetes MellitusOverweightObesity

Locations

Univ of Alabama Birmingham

Birmingham, Alabama 35294

United States

Headlands Research California, LLC

Escondido, California 92025

United States

Torrance Clinical Research Institute, Inc.

Lomita, California 90717

United States

Diablo Clinical Research, Inc.

Walnut Creek, California 94598

United States

Northeast Research Institute

Fleming Island, Florida 32003

United States

Jacksonville Ctr Clin Res

Jacksonville, Florida 32216

United States

Florida Institute for Clinical Research, LLC

Orlando, Florida 32825

United States

Oviedo Medical Research, LLC

Oviedo, Florida 32765

United States

International Diabetes Center

Minneapolis, Minnesota 55416

United States

Southgate Medical Group, LLP

West Seneca, New York 14224

United States

Spartanburg Medical Research

Spartanburg, South Carolina 29303

United States

M3 Wake Research Chattanooga

Chattanooga, Tennessee 37421

United States

UT Southwestern Med Center

Dallas, Texas 75390

United States

PlanIt Research, PLLC

Houston, Texas 77079

United States

National Clin Res Inc.

Richmond, Virginia 23294

United States

MICA- Medicina e Investigación Cardiometabólica

Manuel Alberti, Buenos Aires B1669

Argentina

Kynet Recoleta

Buenos Aires, C1119ACU

Argentina

Centro médico privado Cemaic

Córdoba, X5008

Argentina

CEDIR - Centro de diagnóstico y rehabilitación Santa Fe

Santa Fe, S3000FSO

Argentina

Cline Research Center

Curitiba, Paraná 80030-480

Brazil

PUCCAMP - Hospital e Maternidade Celso Pierro

Campinas, São Paulo 13060-803

Brazil

CPCLIN - Centro de Pesquisas Clínicas

São Paulo, São Paulo 01228-200

Brazil

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

São Paulo, São Paulo 05403-000

Brazil

Opca bolnica Karlovac

Karlovac, 47000

Croatia

Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology

Krapinske Toplice, 49217

Croatia

Specijalna bolnica Thalassotherapia

Opatija, 51 410

Croatia

Poliklinika SLAVONIJA OSIJEK

Osijek, 31000

Croatia

Opca bolnica Pula

Pula, 52100

Croatia

Poliklinika za oftalmologiju optometriju i neurologiju Lux

Solin, 21210

Croatia

Opca bolnica Varazdin_Endocrinology

Varaždin, 42 000

Croatia

Poliklinika Solmed

Zagreb, 10000

Croatia

Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ

Szeged, Csongrád-Csanád 6725

Hungary

DRC Kft.

Balatonfüred, 8230

Hungary

Szent Margit Rendelőintézet Nonprofit Kft.

Budapest, 1032

Hungary

Semmelweis Egyetem

Budapest, 1083

Hungary

PVN Kutató Kft.

Budapest, 1102

Hungary

Észak-Pesti Centrumkórház Honvédkórház - Diabetológia Szakrendelés

Budapest, 1134

Hungary

Trantor 99 Bt

Budapest, H-1213

Hungary

Somogy Vármegyei Kaposi Mór Oktató Kórház

Kaposvár, 7400

Hungary

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

Bologna, Emilia-Romagna 40138

Italy

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

Rome, Lazio 00161

Italy

Grande Ospedale Metropolitano Niguarda - Dipartimento Medico Polispecialistico - Diabetologia

Milan, Lombardy 20159

Italy

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

Palermo, Sicily 90127

Italy

IRCCS Ospedale San Raffaele Milano

Milan, 20132

Italy

Dip. di Medicina Interna Policlinico Universitario Palermo

Palermo, 90127

Italy

Centro de Investigacion Clinica Endocrinologica de Jalisco

Guadalajara, Jalisco 44670

Mexico

Clinstile S.A. de C.V.

Col Roma Norte, Mexico City 06700

Mexico

Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab

Distrito Federal, México, D.F. 14080

Mexico

Unidad Medica para la Salud Integral (UMSI)

San Nicolás de los Garza, Nuevo León 66465

Mexico

Centro de Investigación Clinica de Oaxaca (CICLO)

Oaxaca City, Oaxaca 68020

Mexico

Consultorio de Endocrinología y Pediatría

Puebla City, 72190

Mexico

S.C. Top Diabet Srl

Craiova, Dolj 200515

Romania

Poli Cardinal Med Srl

Reghin, Mureș County 545300

Romania

CMI Dr. Pletea Noemi SRL

Bacau, 600154

Romania

SC Nutrilife SRL

Bucharest, 013764

Romania

SC Clinica Diabnutrimed S.R.L.

Bucharest, 020359

Romania

Diabet Med SRL

Bucharest, 050913

Romania

Cmi Dr. Cojocaru Cristina

Constanța, 900512

Romania

A&C Medical Prime S.R.L.

Craiova, 200692

Romania

Spital Judetean De Urgenta Satu Mare

Satu Mare, 440055

Romania

DIA - KONTROL s.r.o.

Levice, 93401

Slovakia

Narodny Endokrinologicky a diabetologicky ustav

Ľubochňa, 03491

Slovakia

OLIVER - MED s.r.o.

Rimavská Sobota, 979 01

Slovakia

Peter Farkas MD, s.r.o.

Šahy, 93601

Slovakia

DEImedi, s. r. o.

Šurany, 942 01

Slovakia

ARETEUS s.r.o.

Trebišov, 075 01

Slovakia

ARETEUS s.r.o.

Trebišov, 075 01

Slovakia

Seoul National University Bundang Hospital_Endocrinology

Seoungnam-si, Gyeonggi-do 13620

South Korea

Chonnam National University Hospital_Endocrinology

Gwangju, 61469

South Korea

Kyunghee University Medical Center_Endocrinology

Seoul, 02447

South Korea

Seoul National University Hospital_Endocrinology

Seoul, 03080

South Korea

Severance Hospital, Yonsei University Health System_Endocrinology

Seoul, 03722

South Korea

Asan Medical Center_Endocrinology

Seoul, 05505

South Korea

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

Seoul, 07345

South Korea