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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Novo Nordisk A/S • ClinicalTrials.gov ID: NCT07339423

Registry updated: 2026-09-24
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Description

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.

Interventions

  • NNC0487-0111 (Drug)
    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) (Drug)
    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

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.

Conditions

Obesity

Locations

  • 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 and KDCILM, LLC — 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
  • Universitair Ziekenhuis Gent — Ghent, Belgium
  • UZ Leuven - Endocrinology — Leuven, Belgium
  • MECLINAS — Mechelen, Belgium
  • AZ Delta - Roeselare — Roeselare, Belgium
  • C-Health Partners — 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 - Vejle — Vejle, Region Syddanmark, Denmark
  • 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
  • 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_Service d'Endocrinologie-Diabétologie-Maladies Métaboliques — Vénissieux, France
  • Herz- und Diabeteszentrum NRW - Bad Oeynhausen — Bad Oeynhausen, Germany
  • Zentrum für klinische Studien Südbrandenburg 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
  • EMS Healthcare — Macclesfield, North West England, United Kingdom
  • Pickering Medical Practice — Pickering, North Yorkshire, United Kingdom
  • The Crouch Oak Family Practice — Addlestone, Surrey, United Kingdom
  • The Health Centre — Bradford on Avon, United Kingdom
  • HMC Health - Heston - The Meadows Centre for Health — 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record