AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight
AMAZE 1
Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Obesity (AMAZE 1)
3 other identifiers
interventional
1,150
9 countries
72
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 obesity
Started Feb 2026
Longer than P75 for phase_3 obesity
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2026
CompletedFirst Posted
Study publicly available on registry
January 14, 2026
CompletedStudy Start
First participant enrolled
February 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 21, 2029
May 13, 2026
May 1, 2026
3.3 years
January 13, 2026
May 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Relative change in body weight
Measured as percentage of body weight.
From baseline (week 0) to week 84
Secondary Outcomes (24)
Change in waist circumference
From baseline (week 0) to week 84 and week 136
Change in systolic blood pressure (SBP)
From baseline (week 0) to week 84 and week 136
Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score
From baseline (week 0) to week 84 and week 136
Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score
From baseline (week 0) to week 84 and week 136
Change in body weight
From baseline (week 0) to week 84 and week 136
- +19 more secondary outcomes
Study Arms (2)
NNC0487-0111
EXPERIMENTALParticipants 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.
Placebo
PLACEBO COMPARATORParticipants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Interventions
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 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (72)
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
UZ Gent - Endocrinologie - Diabetologie
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2026
First Posted
January 14, 2026
Study Start
February 24, 2026
Primary Completion (Estimated)
June 26, 2029
Study Completion (Estimated)
August 21, 2029
Last Updated
May 13, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com