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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-24

Study Completion Date

2029-08-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

NNC0487-0111

Intervention Type 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

Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

Group Type PLACEBO_COMPARATOR

Placebo (matched to NNC0487-0111)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

South Broward Research LLC

Miramar, Florida, United States

Site Status

Clinical Neuroscience Solution

Orlando, Florida, United States

Site Status

Hope Clin Res & Wellness

Conyers, Georgia, United States

Site Status

Endeavor Health

Skokie, Illinois, United States

Site Status

Midwest Inst For Clin Res

Indianapolis, Indiana, United States

Site Status

StudyMetrix Research LLC

City of Saint Peters, Missouri, United States

Site Status

New York Gastroenterology Associates

New York, New York, United States

Site Status

UNC Eastowne Medical Office

Chapel Hill, North Carolina, United States

Site Status

PharmQuest Life Sciences LLC

Greensboro, North Carolina, United States

Site Status

Accellacare

Wilmington, North Carolina, United States

Site Status

UPA Ctr Weight and Eating Dis

Philadelphia, Pennsylvania, United States

Site Status

Clinical Res Collaborative

Cumberland, Rhode Island, United States

Site Status

Medical Uni of SC Charleston

Charleston, South Carolina, United States

Site Status

Coastal Carolina Research Ctr

North Charleston, South Carolina, United States

Site Status

Hillcrest Clinical Research

Simpsonville, South Carolina, United States

Site Status

Amarillo Medical Specialists

Amarillo, Texas, United States

Site Status

Velocity Clinical Res-Dallas

Dallas, Texas, United States

Site Status

Care United Research, LLC

Forney, Texas, United States

Site Status

Washington Cntr Weight Mgmt

Arlington, Virginia, United States

Site Status

Health Res of Hampton Roads

Newport News, Virginia, United States

Site Status

Selma Medical Associates

Winchester, Virginia, United States

Site Status

Rainier Clin Res Ctr Inc

Renton, Washington, United States

Site Status

Fundación CESIM

Santa Rosa, La Pampa Province, Argentina

Site Status

Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli

Buenos Aires, , Argentina

Site Status

Instituto de Investigaciones Clínicas Córdoba

Córdoba, , Argentina

Site Status

Sanatorio Esperanza

Esperanza, Santa Fe, , Argentina

Site Status

CIPADI

Godoy Cruz, , Argentina

Site Status

Instituto de Investigaciones Clinicas San Nicolás

San Nicolás, , Argentina

Site Status

Sydney Clinical Trials

Campbelltown, New South Wales, Australia

Site Status

Sydney Cardiometabolic Centre

Liverpool, New South Wales, Australia

Site Status

Hunter Diabetes Centre

Merewether, New South Wales, Australia

Site Status

Heart of Australia

Chelmer, Queensland, Australia

Site Status

HUB - Hôpital Erasme

Brussels, , Belgium

Site Status

UZA - UZ Antwerpen - Department of Endocrinology

Edegem, , Belgium

Site Status

UZ Gent - Endocrinologie - Diabetologie

Ghent, , Belgium

Site Status

UZ Leuven - Endocrinology

Leuven, , Belgium

Site Status

MECLINAS

Mechelen, , Belgium

Site Status

AZ Delta - Roeselare

Roeselare, , Belgium

Site Status

C-endo Diab Endo Clin Calgery

Calgary, Alberta, Canada

Site Status

Ocean West Research Clinic

Surrey, British Columbia, Canada

Site Status

G.A. Research Associates Ltd.

Moncton, New Brunswick, Canada

Site Status

Nova Scotia Hlth Halifax

Halifax, Nova Scotia, Canada

Site Status

Milestone Research

London, Ontario, Canada

Site Status

Sanos Clinic - Gandrup

Gandrup, , Denmark

Site Status

Steno Diabetes Center Nordjylland

Gistrup, , Denmark

Site Status

Gentofte Hospital - Center for Klinisk Metabolisk Forskning

Hellerup, , Denmark

Site Status

Hillerød Endokrinologisk amb. H0652

Hillerød, , Denmark

Site Status

Hvidovre Hospital Endokrinologisk forsknings afsnit 159

Hvidovre, , Denmark

Site Status

Sanos Clinic - Vejle

Vejle, , Denmark

Site Status

HOPITAL EUROPEEN GEORGES POMPIDOU_Service de nutrition et diabétologie

Paris, , France

Site Status

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

Pierre-Bénite, , France

Site Status

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

Saint-Herblain, , France

Site Status

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

Toulouse, , France

Site Status

Centre de Recherche Clinique Portes Du Sud

Vénissieux, , France

Site Status

Herz- und Diabeteszentrum NRW - Bad Oeynhausen

Bad Oeynhausen, , Germany

Site Status

Zentrum fuer klinische Studien Suedbrandenburg GmbH

Elsterwerda, , Germany

Site Status

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

Fulda, , Germany

Site Status

SMO.MD GmbH - Zentrum für klinische Studien

Magdeburg, , Germany

Site Status

Institut für Diabetesforschung Osnabrück

Osnabrück, , Germany

Site Status

Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann

Witten, , Germany

Site Status

Fowey River Practice

Fowey, Cornwall, United Kingdom

Site Status

The Adam Practice

Poole, Dorset, United Kingdom

Site Status

Pickering Medical Practice

Pickering, North Yorkshire, United Kingdom

Site Status

Crouch Oak Family Practice

Addlestone, Surrey, United Kingdom

Site Status

The Health Centre

Bradford-on-Avon, , United Kingdom

Site Status

EMS Healthcare

Cheshire, , United Kingdom

Site Status

HMC Health - Hounslow

Hounslow, , United Kingdom

Site Status

Kiltearn Medical Centre

Nantwich, , United Kingdom

Site Status

Knowle House Surgery

Plymouth, , United Kingdom

Site Status

Clifton Medical Centre

Rotherham, , United Kingdom

Site Status

Staploe Medical Centre

Soham, , United Kingdom

Site Status

Albany House Medical Centre

Wellingborough, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Belgium Canada Denmark France Germany United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Novo Nordisk

Role: CONTACT

(+1) 866-867-7178

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

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

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.