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NCT07339423PHASE3Recruiting

AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight

Novo Nordisk A/S

Start Date

2/24/2026

Completion Date

8/21/2029

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. 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 (a 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

Key Inclusion Criteria: * Male or female (sex at birth). * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * History of at least one self-reported unsuccessful dietary effort to lose body weight. Key Exclusion Criteria: * HbA1c ≥ 6.5% (48 millimole per mole \[mmol/mol\]) as measured by the central laboratory at screening. * History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records. * 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

Obesity

Locations

South Broward Research LLC

Miramar, Florida 33027

United States

Clinical Neuroscience Solution

Orlando, Florida 32801

United States

Hope Clin Res & Wellness

Conyers, Georgia 30094

United States

Endeavor Health

Skokie, Illinois 60077

United States

Midwest Inst For Clin Res

Indianapolis, Indiana 46260

United States

StudyMetrix Research LLC

City of Saint Peters, Missouri 63303

United States

New York Gastroenterology Associates

New York, New York 10075

United States

UNC Eastowne Medical Office

Chapel Hill, North Carolina 27514

United States

PharmQuest Life Sciences LLC

Greensboro, North Carolina 27408

United States

Accellacare and KDCILM, LLC

Wilmington, North Carolina 28401

United States

UPA Ctr Weight and Eating Dis

Philadelphia, Pennsylvania 19104

United States

Clinical Res Collaborative

Cumberland, Rhode Island 02864

United States

Medical Uni of SC Charleston

Charleston, South Carolina 29425

United States

Coastal Carolina Research Ctr

North Charleston, South Carolina 29405

United States

Hillcrest Clinical Research

Simpsonville, South Carolina 29681-1538

United States

Amarillo Medical Specialists

Amarillo, Texas 79124

United States

Velocity Clinical Res-Dallas

Dallas, Texas 75230-6855

United States

Care United Research, LLC

Forney, Texas 75126

United States

Washington Cntr Weight Mgmt

Arlington, Virginia 22206

United States

Health Res of Hampton Roads

Newport News, Virginia 23606

United States

Selma Medical Associates

Winchester, Virginia 22601-3834

United States

Rainier Clin Res Ctr Inc

Renton, Washington 98057

United States

Fundación CESIM

Santa Rosa, La Pampa Province 6300

Argentina

Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli

Buenos Aires, C1425AGC

Argentina

Instituto de Investigaciones Clínicas Córdoba

Córdoba, 5000

Argentina

Sanatorio Esperanza

Esperanza, Santa Fe, S3080BQV

Argentina

CIPADI

Godoy Cruz, M5501ARP

Argentina

Instituto de Investigaciones Clinicas San Nicolás

San Nicolás, B2900

Argentina

Sydney Clinical Trials

Campbelltown, New South Wales 2560

Australia

Sydney Cardiometabolic Centre

Liverpool, New South Wales 2170

Australia

Hunter Diabetes Centre

Merewether, New South Wales 2291

Australia

Heart of Australia

Chelmer, Queensland 4068

Australia

HUB - Hôpital Erasme

Brussels, 1070

Belgium

UZA - UZ Antwerpen - Department of Endocrinology

Edegem, 2650

Belgium

Universitair Ziekenhuis Gent

Ghent, 9000

Belgium

UZ Leuven - Endocrinology

Leuven, 3000

Belgium

MECLINAS

Mechelen, 2800

Belgium

AZ Delta - Roeselare

Roeselare, 8800

Belgium

C-Health Partners

Calgary, Alberta T2V 4J2

Canada

Ocean West Research Clinic

Surrey, British Columbia V3Z 2N6

Canada

G.A. Research Associates Ltd.

Moncton, New Brunswick E1G 1A7

Canada

Nova Scotia Hlth Halifax

Halifax, Nova Scotia B3H1V7

Canada

Milestone Research

London, Ontario N5W 6A2

Canada

Sanos Clinic - Vejle

Vejle, Region Syddanmark 7100

Denmark

Sanos Clinic - Gandrup

Gandrup, 9362

Denmark

Steno Diabetes Center Nordjylland

Gistrup, 9260

Denmark

Gentofte Hospital - Center for Klinisk Metabolisk Forskning

Hellerup, 2900

Denmark

Hillerød Endokrinologisk amb. H0652

Hillerød, 3400

Denmark

Hvidovre Hospital Endokrinologisk forsknings afsnit 159

Hvidovre, 2650

Denmark

HOPITAL EUROPEEN GEORGES POMPIDOU_Service de nutrition et diabétologie

Paris, 75015

France

HCL-HOPITAL LYON SUD_Service d'Endocrinologie-Diabète-Nutrition

Pierre-Bénite, 69310

France

CHU NANTES - HOPITAL NORD LAENNEC_Service d'Endocrinologie-Diabétologie-Nutrition

Saint-Herblain, 44800

France

CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE-HOPITAL RANGUEIL-Service de diabétologie et nutrition

Toulouse, 31059

France

CENTRE DE RECHERCHE CLINIQUE PORTES DU SUD_Service d'Endocrinologie-Diabétologie-Maladies Métaboliques

Vénissieux, 69200

France

Herz- und Diabeteszentrum NRW - Bad Oeynhausen

Bad Oeynhausen, 32545

Germany

Zentrum für klinische Studien Südbrandenburg GmbH

Elsterwerda, 04910

Germany

MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien

Fulda, 36037

Germany

SMO.MD GmbH - Zentrum für klinische Studien

Magdeburg, 39120

Germany

Institut für Diabetesforschung Osnabrück

Osnabrück, 49080

Germany

Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann

Witten, 58455

Germany

Fowey River Practice

Fowey, Cornwall PL23 1DT

United Kingdom

The Adam Practice

Poole, Dorset BH16 5PW

United Kingdom

Pickering Medical Practice

Pickering, North Yorkshire YO18 8BL

United Kingdom

The Crouch Oak Family Practice

Addlestone, Surrey KT15 2BH

United Kingdom

The Health Centre

Bradford-on-Avon, BA15 1DQ

United Kingdom

EMS Healthcare

Cheshire, CH65 4LE

United Kingdom

HMC Health - Heston - The Meadows Centre for Health

Hounslow, TW4 7NJ

United Kingdom

Kiltearn Medical Centre

Nantwich, CW5 5NX

United Kingdom

Knowle House Surgery

Plymouth, PL5 3JB

United Kingdom

Clifton Medical Centre

Rotherham, S65 1DA

United Kingdom

Staploe Medical Centre

Soham, CB7 5JD

United Kingdom

Albany House Medical Centre

Wellingborough, NN8 4RW

United Kingdom