AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight
NCT ID: NCT07339423
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
1150 participants
INTERVENTIONAL
2026-02-24
2029-08-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NNC0487-0111
Participants will be randomized to receive 1 out of 4 different dose levels subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
NNC0487-0111
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Placebo
Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Placebo (matched to NNC0487-0111)
Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Interventions
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NNC0487-0111
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Placebo (matched to NNC0487-0111)
Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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South Broward Research LLC
Miramar, Florida, United States
Clinical Neuroscience Solution
Orlando, Florida, United States
Hope Clin Res & Wellness
Conyers, Georgia, United States
Endeavor Health
Skokie, Illinois, United States
Midwest Inst For Clin Res
Indianapolis, Indiana, United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, United States
New York Gastroenterology Associates
New York, New York, United States
UNC Eastowne Medical Office
Chapel Hill, North Carolina, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, United States
Accellacare
Wilmington, North Carolina, United States
UPA Ctr Weight and Eating Dis
Philadelphia, Pennsylvania, United States
Clinical Res Collaborative
Cumberland, Rhode Island, United States
Medical Uni of SC Charleston
Charleston, South Carolina, United States
Coastal Carolina Research Ctr
North Charleston, South Carolina, United States
Hillcrest Clinical Research
Simpsonville, South Carolina, United States
Amarillo Medical Specialists
Amarillo, Texas, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
Care United Research, LLC
Forney, Texas, United States
Washington Cntr Weight Mgmt
Arlington, Virginia, United States
Health Res of Hampton Roads
Newport News, Virginia, United States
Selma Medical Associates
Winchester, Virginia, United States
Rainier Clin Res Ctr Inc
Renton, Washington, United States
Fundación CESIM
Santa Rosa, La Pampa Province, Argentina
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
Buenos Aires, , Argentina
Instituto de Investigaciones Clínicas Córdoba
Córdoba, , Argentina
Sanatorio Esperanza
Esperanza, Santa Fe, , Argentina
CIPADI
Godoy Cruz, , Argentina
Instituto de Investigaciones Clinicas San Nicolás
San Nicolás, , Argentina
Sydney Clinical Trials
Campbelltown, New South Wales, Australia
Sydney Cardiometabolic Centre
Liverpool, New South Wales, Australia
Hunter Diabetes Centre
Merewether, New South Wales, Australia
Heart of Australia
Chelmer, Queensland, Australia
HUB - Hôpital Erasme
Brussels, , Belgium
UZA - UZ Antwerpen - Department of Endocrinology
Edegem, , Belgium
UZ Gent - Endocrinologie - Diabetologie
Ghent, , Belgium
UZ Leuven - Endocrinology
Leuven, , Belgium
MECLINAS
Mechelen, , Belgium
AZ Delta - Roeselare
Roeselare, , Belgium
C-endo Diab Endo Clin Calgery
Calgary, Alberta, Canada
Ocean West Research Clinic
Surrey, British Columbia, Canada
G.A. Research Associates Ltd.
Moncton, New Brunswick, Canada
Nova Scotia Hlth Halifax
Halifax, Nova Scotia, Canada
Milestone Research
London, Ontario, Canada
Sanos Clinic - Gandrup
Gandrup, , Denmark
Steno Diabetes Center Nordjylland
Gistrup, , Denmark
Gentofte Hospital - Center for Klinisk Metabolisk Forskning
Hellerup, , Denmark
Hillerød Endokrinologisk amb. H0652
Hillerød, , Denmark
Hvidovre Hospital Endokrinologisk forsknings afsnit 159
Hvidovre, , Denmark
Sanos Clinic - Vejle
Vejle, , Denmark
HOPITAL EUROPEEN GEORGES POMPIDOU_Service de nutrition et diabétologie
Paris, , France
HCL-HOPITAL LYON SUD_Service d'Endocrinologie-Diabète-Nutrition
Pierre-Bénite, , France
CHU NANTES - HOPITAL NORD LAENNEC_Service d'Endocrinologie-Diabétologie-Nutrition
Saint-Herblain, , France
CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE-HOPITAL RANGUEIL-Service de diabétologie et nutrition
Toulouse, , France
Centre de Recherche Clinique Portes Du Sud
Vénissieux, , France
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, , Germany
Zentrum fuer klinische Studien Suedbrandenburg GmbH
Elsterwerda, , Germany
MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien
Fulda, , Germany
SMO.MD GmbH - Zentrum für klinische Studien
Magdeburg, , Germany
Institut für Diabetesforschung Osnabrück
Osnabrück, , Germany
Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann
Witten, , Germany
Fowey River Practice
Fowey, Cornwall, United Kingdom
The Adam Practice
Poole, Dorset, United Kingdom
Pickering Medical Practice
Pickering, North Yorkshire, United Kingdom
Crouch Oak Family Practice
Addlestone, Surrey, United Kingdom
The Health Centre
Bradford-on-Avon, , United Kingdom
EMS Healthcare
Cheshire, , United Kingdom
HMC Health - Hounslow
Hounslow, , United Kingdom
Kiltearn Medical Centre
Nantwich, , United Kingdom
Knowle House Surgery
Plymouth, , United Kingdom
Clifton Medical Centre
Rotherham, , United Kingdom
Staploe Medical Centre
Soham, , United Kingdom
Albany House Medical Centre
Wellingborough, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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U1111-1313-6262
Identifier Type: OTHER
Identifier Source: secondary_id
2024-520440-42
Identifier Type: OTHER
Identifier Source: secondary_id
NN9490-8021
Identifier Type: -
Identifier Source: org_study_id
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