AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight
Recruiting · NCT07339423 · Interventional (participants receive a specific treatment) · Lead sponsor: Novo Nordisk A/S
View the official record on ClinicalTrials.gov →Interventions studied
NNC0487-0111Placebo (matched to NNC0487-0111)
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. 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 13 US states.
- 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
- Herz- und Diabeteszentrum NRW - Bad Oeynhausen - Bad Oeynhausen, Germany
- The Health Centre - Bradford-on-Avon, United Kingdom
- HUB - Hôpital Erasme - Brussels, Belgium
- Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli - Buenos Aires, Argentina
- EMS Healthcare - Cheshire, United Kingdom
- Instituto de Investigaciones Clínicas Córdoba - Córdoba, Argentina
- UZA - UZ Antwerpen - Department of Endocrinology - Edegem, Belgium
- Zentrum für klinische Studien Südbrandenburg GmbH - Elsterwerda, Germany
- Sanatorio Esperanza - Esperanza, Santa Fe, Argentina
- MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien - Fulda, Germany
- Sanos Clinic - Gandrup - Gandrup, Denmark
- Universitair Ziekenhuis Gent - Ghent, Belgium
- Steno Diabetes Center Nordjylland - Gistrup, Denmark
- CIPADI - Godoy Cruz, Argentina
- Gentofte Hospital - Center for Klinisk Metabolisk Forskning - Hellerup, Denmark
- Hillerød Endokrinologisk amb. H0652 - Hillerød, Denmark
- HMC Health - Heston - The Meadows Centre for Health - Hounslow, United Kingdom
- Hvidovre Hospital Endokrinologisk forsknings afsnit 159 - Hvidovre, Denmark
- UZ Leuven - Endocrinology - Leuven, Belgium
- SMO.MD GmbH - Zentrum für klinische Studien - Magdeburg, Germany
- MECLINAS - Mechelen, Belgium
- Kiltearn Medical Centre - Nantwich, United Kingdom
- Institut für Diabetesforschung Osnabrück - Osnabrück, Germany
- HOPITAL EUROPEEN GEORGES POMPIDOU_Service de nutrition et diabétologie - Paris, France
- HCL-HOPITAL LYON SUD_Service d'Endocrinologie-Diabète-Nutrition - Pierre-Bénite, France
- Knowle House Surgery - Plymouth, United Kingdom
- AZ Delta - Roeselare - Roeselare, Belgium
- Clifton Medical Centre - Rotherham, United Kingdom
- CHU NANTES - HOPITAL NORD LAENNEC_Service d'Endocrinologie-Diabétologie-Nutrition - Saint-Herblain, France
- Instituto de Investigaciones Clinicas San Nicolás - San Nicolás, Argentina
- Staploe Medical Centre - Soham, United Kingdom
- 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
- Albany House Medical Centre - Wellingborough, United Kingdom
- Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann - Witten, Germany
- C-Health Partners - Calgary, Alberta, Canada
- Ocean West Research Clinic - Surrey, British Columbia, Canada
- Fowey River Practice - Fowey, Cornwall, United Kingdom
Showing 60 of 72 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →