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

June 1, 2026 updated by: Novo Nordisk A/S

Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Obesity (AMAZE 1)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1425AGC
        • Recruiting
        • Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
      • Córdoba, Argentina, 5000
        • Recruiting
        • Instituto de Investigaciones Clínicas Córdoba
      • Esperanza, Santa Fe, Argentina, S3080BQV
        • Recruiting
        • Sanatorio Esperanza
      • Godoy Cruz, Argentina, M5501ARP
        • Recruiting
        • CIPADI
      • San Nicolás, Argentina, B2900
        • Recruiting
        • Instituto de Investigaciones Clinicas San Nicolas
    • La Pampa Province
      • Santa Rosa, La Pampa Province, Argentina, 6300
        • Recruiting
        • Fundación CESIM
  • Australia
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Recruiting
        • Sydney Clinical Trials
      • Liverpool, New South Wales, Australia, 2170
        • Recruiting
        • Sydney Cardiometabolic Centre
      • Merewether, New South Wales, Australia, 2291
        • Recruiting
        • Hunter Diabetes Centre
    • Queensland
      • Chelmer, Queensland, Australia, 4068
        • Recruiting
        • Heart of Australia
  • Belgium
      • Brussels, Belgium, 1070
        • Recruiting
        • HUB - Hôpital Erasme
      • Edegem, Belgium, 2650
        • Recruiting
        • UZA - UZ Antwerpen - Department of Endocrinology
      • Ghent, Belgium, 9000
        • Recruiting
        • UZ Gent - Endocrinologie - Diabetologie
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven - Endocrinology
      • Mechelen, Belgium, 2800
        • Recruiting
        • Meclinas
      • Roeselare, Belgium, 8800
        • Recruiting
        • AZ Delta - Roeselare
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2V 4J2
        • Not yet recruiting
        • C-Health Partners
    • British Columbia
      • Surrey, British Columbia, Canada, V3Z 2N6
        • Recruiting
        • Ocean West Research Clinic
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • Recruiting
        • G.A. Research Associates Ltd.
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H1V7
        • Recruiting
        • Nova Scotia Hlth Halifax
    • Ontario
      • London, Ontario, Canada, N5W 6A2
        • Recruiting
        • Milestone Research
  • Denmark
      • Gandrup, Denmark, 9362
        • Recruiting
        • Sanos Clinic - Gandrup
      • Gistrup, Denmark, 9260
        • Completed
        • Steno Diabetes Center Nordjylland
      • Hellerup, Denmark, 2900
        • Not yet recruiting
        • Gentofte Hospital - Center for Klinisk Metabolisk Forskning
      • Hillerød, Denmark, 3400
        • Not yet recruiting
        • Hillerød Endokrinologisk amb. H0652
      • Hvidovre, Denmark, 2650
        • Recruiting
        • Hvidovre Hospital Endokrinologisk forsknings afsnit 159
    • Region Syddanmark
      • Vejle, Region Syddanmark, Denmark, 7100
        • Recruiting
        • Sanos Clinic - Vejle
  • France
      • Paris, France, 75015
        • Recruiting
        • HOPITAL EUROPEEN GEORGES POMPIDOU_Service de nutrition et diabétologie
      • Pierre-Bénite, France, 69310
        • Recruiting
        • HCL-HOPITAL LYON SUD_Service d'Endocrinologie-Diabète-Nutrition
      • Saint-Herblain, France, 44800
        • Recruiting
        • CHU NANTES - HOPITAL NORD LAENNEC_Service d'Endocrinologie-Diabétologie-Nutrition
      • Toulouse, France, 31059
        • Recruiting
        • CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE-HOPITAL RANGUEIL-Service de diabétologie et nutrition
      • Vénissieux, France, 69200
        • Recruiting
        • CENTRE DE RECHERCHE CLINIQUE PORTES DU SUD_Service d'Endocrinologie-Diabétologie-Maladies Métaboliques
  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Recruiting
        • Herz- und Diabeteszentrum NRW - Bad Oeynhausen
      • Elsterwerda, Germany, 04910
        • Recruiting
        • Zentrum für klinische Studien Südbrandenburg GmbH
      • Fulda, Germany, 36037
        • Recruiting
        • MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien
      • Magdeburg, Germany, 39120
        • Not yet recruiting
        • SMO.MD GmbH - Zentrum für klinische Studien
      • Osnabrück, Germany, 49080
        • Recruiting
        • Institut für Diabetesforschung Osnabrück
      • Witten, Germany, 58455
        • Recruiting
        • Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann
  • United Kingdom
      • Bradford-on-Avon, United Kingdom, BA15 1DQ
        • Recruiting
        • The Health Centre
      • Cheshire, United Kingdom, CH65 4LE
        • Recruiting
        • EMS Healthcare
      • Hounslow, United Kingdom, TW4 7NJ
        • Recruiting
        • HMC Health - Heston - The Meadows Centre for Health
      • Nantwich, United Kingdom, CW5 5NX
        • Recruiting
        • Kiltearn Medical Centre
      • Plymouth, United Kingdom, PL5 3JB
        • Recruiting
        • Knowle House Surgery
      • Rotherham, United Kingdom, S65 1DA
        • Recruiting
        • Clifton Medical Centre
      • Soham, United Kingdom, CB7 5JD
        • Recruiting
        • Staploe Medical Centre
      • Wellingborough, United Kingdom, NN8 4RW
        • Recruiting
        • Albany House Medical Centre
    • Cornwall
      • Fowey, Cornwall, United Kingdom, PL23 1DT
        • Not yet recruiting
        • Fowey River Practice
    • Dorset
      • Poole, Dorset, United Kingdom, BH16 5PW
        • Recruiting
        • The Adam Practice
    • North Yorkshire
      • Pickering, North Yorkshire, United Kingdom, YO18 8BL
        • Recruiting
        • Pickering Medical Practice
    • Surrey
      • Addlestone, Surrey, United Kingdom, KT15 2BH
        • Recruiting
        • The Crouch Oak Family Practice
  • United States
    • Florida
      • Miramar, Florida, United States, 33027
        • Recruiting
        • South Broward Research LLC
      • Orlando, Florida, United States, 32801
        • Recruiting
        • Clinical Neuroscience Solution
    • Georgia
      • Conyers, Georgia, United States, 30094
        • Recruiting
        • Hope Clin Res & Wellness
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Recruiting
        • Endeavor Health
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Midwest Inst For Clin Res
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
        • Recruiting
        • StudyMetrix Research LLC
    • New York
      • New York, New York, United States, 10075
        • Recruiting
        • New York Gastroenterology Associates
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • UNC Eastowne Medical Office
      • Greensboro, North Carolina, United States, 27408
        • Recruiting
        • PharmQuest Life Sciences LLC
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • Accellacare and KDCILM, LLC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • UPA Ctr Weight and Eating Dis
    • Rhode Island
      • Cumberland, Rhode Island, United States, 02864
        • Recruiting
        • Clinical Res Collaborative
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical Uni of SC Charleston
      • North Charleston, South Carolina, United States, 29405
        • Recruiting
        • Coastal Carolina Research Ctr
      • Simpsonville, South Carolina, United States, 29681-1538
        • Recruiting
        • Hillcrest Clinical Research
    • Texas
      • Amarillo, Texas, United States, 79124
        • Recruiting
        • Amarillo Medical Specialists
      • Dallas, Texas, United States, 75230-6855
        • Recruiting
        • Velocity Clinical Res-Dallas
      • Forney, Texas, United States, 75126
        • Recruiting
        • Care United Research, LLC
    • Virginia
      • Arlington, Virginia, United States, 22206
        • Recruiting
        • Washington Cntr Weight Mgmt
      • Newport News, Virginia, United States, 23606
        • Recruiting
        • Health Res of Hampton Roads
      • Winchester, Virginia, United States, 22601-3834
        • Recruiting
        • Selma Medical Associates
    • Washington
      • Renton, Washington, United States, 98057
        • Recruiting
        • Rainier Clin Res Ctr Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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 Comparator: Placebo
Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative change in body weight
Time Frame: From baseline (week 0) to week 84
Measured as percentage of body weight.
From baseline (week 0) to week 84

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in waist circumference
Time Frame: From baseline (week 0) to week 84 and week 136
Measured as centimetre (cm).
From baseline (week 0) to week 84 and week 136
Change in systolic blood pressure (SBP)
Time Frame: From baseline (week 0) to week 84 and week 136
Measured as millimetre of mercury (mmHg).
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
Time Frame: From baseline (week 0) to week 84 and week 136
Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100.
From baseline (week 0) to week 84 and week 136
Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score
Time Frame: From baseline (week 0) to week 84 and week 136
Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate better functional health and well-being. The physical functioning ranges from 19.0 to 57.6.
From baseline (week 0) to week 84 and week 136
Change in body weight
Time Frame: From baseline (week 0) to week 84 and week 136
Measured as kilogram (kg).
From baseline (week 0) to week 84 and week 136
Change in body mass index (BMI)
Time Frame: From baseline (week 0) to week 84 and week 136
Measured as kilograms per meter squared (kg/m^2).
From baseline (week 0) to week 84 and week 136
Change in IWQOL-Lite-CT physical composite score
Time Frame: From baseline (week 0) to week 84 and week 136
Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical composite score ranges from 0-100.
From baseline (week 0) to week 84 and week 136
Change in IWQOL-Lite-CT psychosocial composite score
Time Frame: From baseline (week 0) to week 84 and week 136
Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The psychosocial composite score ranges from 0-100.
From baseline (week 0) to week 84 and week 136
Change in IWQOL-Lite-CT total score
Time Frame: From baseline (week 0) to week 84 and week 136
Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The total score ranges from 0-100.
From baseline (week 0) to week 84 and week 136
Change in glycated haemoglobin (HbA1c)
Time Frame: From baseline (week 0) to week 84 and week 136
Measured as percentage of HbA1c.
From baseline (week 0) to week 84 and week 136
Change in fasting plasma glucose (FPG)
Time Frame: From baseline (week 0) to week 84 and week 136
Measured as millimole per liter (mmol/L).
From baseline (week 0) to week 84 and week 136
Ratio to baseline: change in fasting insulin
Time Frame: From baseline (week 0) to week 84 and week 136
Measured as ratio.
From baseline (week 0) to week 84 and week 136
Change in diastolic blood pressure (DBP)
Time Frame: From baseline (week 0) to week 84
Measured as mmHg.
From baseline (week 0) to week 84
Ratio to baseline: change in total cholesterol
Time Frame: From baseline (week 0) to week 84 and week 136
Measured as ratio.
From baseline (week 0) to week 84 and week 136
Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol
Time Frame: From baseline (week 0) to week 84 and week 136
Measured as ratio.
From baseline (week 0) to week 84 and week 136
Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol
Time Frame: From baseline (week 0) to week 84 and week 136
Measured as ratio.
From baseline (week 0) to week 84 and week 136
Ratio to baseline: change in very low-density lipoprotein (VLDL) cholesterol
Time Frame: From baseline (week 0) to week 84 and week 136
Measured as ratio.
From baseline (week 0) to week 84 and week 136
Ratio to baseline: change in non-HDL cholesterol
Time Frame: From baseline (week 0) to week 84 and week 136
Measured as ratio.
From baseline (week 0) to week 84 and week 136
Ratio to baseline: change in triglycerides
Time Frame: From baseline (week 0) to week 84 and week 136
Measured as ratio.
From baseline (week 0) to week 84 and week 136
Ratio to baseline: change in high-sensitivity C-reactive protein (hsCRP)
Time Frame: From baseline (week 0) to week 84 and week 136
Measured as ratio.
From baseline (week 0) to week 84 and week 136
Number of treatment emergent adverse events (TEAEs)
Time Frame: From baseline (week 0) to week 84 and week 140
Measured as events.
From baseline (week 0) to week 84 and week 140
Number of treatment emergent serious adverse events (TESAEs)
Time Frame: From baseline (week 0) to week 84 and week 140
Measured as events.
From baseline (week 0) to week 84 and week 140
Number of TEAEs leading to permanent treatment discontinuation
Time Frame: From baseline (week 0) to week 84 and week 140
Measured as events.
From baseline (week 0) to week 84 and week 140
Relative change in body weight
Time Frame: From baseline (week 0) to week 136
Measured as % of body weight.
From baseline (week 0) to week 136

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2026

Primary Completion (Estimated)

June 26, 2029

Study Completion (Estimated)

August 21, 2029

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9490-8021
  • U1111-1313-6262 (Other Identifier: World Health Organization (WHO))
  • 2024-520440-42 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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