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ObesityPhase 3AMAZE 1NCT07339423

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

A Phase 3 study testing NNC0487-0111 in people with Obesity, run by Novo Nordisk A/S at 72 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
What is being tested?
NNC0487-0111
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,150 participants
Where
72 sitesin 9 countries
Study dates
24 Feb 2026to 21 Aug 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

72 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Novo Nordisk contact

(+1) 866-867-7178

clinicaltrials@novonordisk.com

72 sites in 9 countries

United States22 sites, 22 recruiting

  • Amarillo Medical Specialists

    Amarillo, Texas, 79124

    Recruiting

  • Washington Cntr Weight Mgmt

    Arlington, Virginia, 22206

    Recruiting

  • UNC Eastowne Medical Office

    Chapel Hill, North Carolina, 27514

    Recruiting

  • Medical Uni of SC Charleston

    Charleston, South Carolina, 29425

    Recruiting

  • StudyMetrix Research LLC

    City of Saint Peters, Missouri, 63303

    Recruiting

  • Hope Clin Res & Wellness

    Conyers, Georgia, 30094

    Recruiting

  • Clinical Res Collaborative

    Cumberland, Rhode Island, 02864

    Recruiting

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230-6855

    Recruiting

  • Care United Research, LLC

    Forney, Texas, 75126

    Recruiting

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina, 27408

    Recruiting

  • Midwest Inst For Clin Res

    Indianapolis, Indiana, 46260

    Recruiting

  • South Broward Research LLC

    Miramar, Florida, 33027

    Recruiting

  • New York Gastroenterology Associates

    New York, New York, 10075

    Recruiting

  • Health Res of Hampton Roads

    Newport News, Virginia, 23606

    Recruiting

  • Coastal Carolina Research Ctr

    North Charleston, South Carolina, 29405

    Recruiting

  • Clinical Neuroscience Solution

    Orlando, Florida, 32801

    Recruiting

  • UPA Ctr Weight and Eating Dis

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Rainier Clin Res Ctr Inc

    Renton, Washington, 98057

    Recruiting

  • Hillcrest Clinical Research

    Simpsonville, South Carolina, 29681-1538

    Recruiting

  • Endeavor Health

    Skokie, Illinois, 60077

    Recruiting

  • Accellacare and KDCILM, LLC

    Wilmington, North Carolina, 28401

    Recruiting

  • Selma Medical Associates

    Winchester, Virginia, 22601-3834

    Recruiting

Other trials in United States

United Kingdom12 sites, 12 recruiting

  • The Crouch Oak Family Practice

    Addlestone, Surrey, KT15 2BH

    Recruiting

  • The Health Centre

    Bradford on Avon, BA15 1DQ

    Recruiting

  • Fowey River Practice

    Fowey, Cornwall, PL23 1DT

    Recruiting

  • HMC Health - Heston - The Meadows Centre for Health

    Hounslow, TW4 7NJ

    Recruiting

  • EMS Healthcare

    Macclesfield, North West England, SK10 4TF

    Recruiting

  • Kiltearn Medical Centre

    Nantwich, CW5 5NX

    Recruiting

  • Pickering Medical Practice

    Pickering, North Yorkshire, YO18 8BL

    Recruiting

  • Knowle House Surgery

    Plymouth, PL5 3JB

    Recruiting

  • The Adam Practice

    Poole, Dorset, BH16 5PW

    Recruiting

  • Clifton Medical Centre

    Rotherham, S65 1DA

    Recruiting

  • Staploe Medical Centre

    Soham, CB7 5JD

    Recruiting

  • Albany House Medical Centre

    Wellingborough, NN8 4RW

    Recruiting

Other trials in United Kingdom

Argentina6 sites, 6 recruiting

  • Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli

    Buenos Aires, C1425AGC

    Recruiting

  • Instituto de Investigaciones Clínicas Córdoba

    Córdoba, 5000

    Recruiting

  • Sanatorio Esperanza

    Esperanza, Santa Fe, S3080BQV

    Recruiting

  • CIPADI

    Godoy Cruz, M5501ARP

    Recruiting

  • Instituto de Investigaciones Clinicas San Nicolás

    San Nicolás, B2900

    Recruiting

  • Fundación CESIM

    Santa Rosa, La Pampa Province, 6300

    Recruiting

Other trials in Argentina

Belgium6 sites, 6 recruiting

  • HUB - Hôpital Erasme

    Brussels, 1070

    Recruiting

  • UZA - UZ Antwerpen - Department of Endocrinology

    Edegem, 2650

    Recruiting

  • Universitair Ziekenhuis Gent

    Ghent, 9000

    Recruiting

  • UZ Leuven - Endocrinology

    Leuven, 3000

    Recruiting

  • MECLINAS

    Mechelen, 2800

    Recruiting

  • AZ Delta - Roeselare

    Roeselare, 8800

    Recruiting

Other trials in Belgium

Denmark6 sites, 5 recruiting

  • Sanos Clinic - Gandrup

    Gandrup, 9362

    Recruiting

  • Steno Diabetes Center Nordjylland

    Gistrup, 9260

    Completed

  • Gentofte Hospital - Center for Klinisk Metabolisk Forskning

    Hellerup, 2900

    Recruiting

  • Hillerød Endokrinologisk amb. H0652

    Hillerød, 3400

    Recruiting

  • Hvidovre Hospital Endokrinologisk forsknings afsnit 159

    Hvidovre, 2650

    Recruiting

  • Sanos Clinic - Vejle

    Vejle, Region Syddanmark, 7100

    Recruiting

Other trials in Denmark

Germany6 sites

  • Herz- und Diabeteszentrum NRW - Bad Oeynhausen

    Bad Oeynhausen, 32545

    Active, not recruiting

  • Zentrum für klinische Studien Südbrandenburg GmbH

    Elsterwerda, 04910

    Active, not recruiting

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

    Fulda, 36037

    Active, not recruiting

  • SMO.MD GmbH - Zentrum für klinische Studien

    Magdeburg, 39120

    Active, not recruiting

  • Institut für Diabetesforschung Osnabrück

    Osnabrück, 49080

    Active, not recruiting

  • Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann

    Witten, 58455

    Active, not recruiting

Other trials in Germany

Canada5 sites, 5 recruiting

  • C-Health Partners

    Calgary, Alberta, T2V 4J2

    Recruiting

  • Nova Scotia Hlth Halifax

    Halifax, Nova Scotia, B3H1V7

    Recruiting

  • Milestone Research

    London, Ontario, N5W 6A2

    Recruiting

  • G.A. Research Associates Ltd.

    Moncton, New Brunswick, E1G 1A7

    Recruiting

  • Ocean West Research Clinic

    Surrey, British Columbia, V3Z 2N6

    Recruiting

Other trials in Canada

France5 sites, 5 recruiting

  • HOPITAL EUROPEEN GEORGES POMPIDOU_Service de nutrition et diabétologie

    Paris, 75015

    Recruiting

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

    Pierre-Bénite, 69310

    Recruiting

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

    Saint-Herblain, 44800

    Recruiting

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

    Toulouse, 31059

    Recruiting

  • CENTRE DE RECHERCHE CLINIQUE PORTES DU SUD_Service d'Endocrinologie-Diabétologie-Maladies Métaboliques

    Vénissieux, 69200

    Recruiting

Other trials in France

Australia4 sites, 4 recruiting

  • Sydney Clinical Trials

    Campbelltown, New South Wales, 2560

    Recruiting

  • Heart of Australia

    Chelmer, Queensland, 4068

    Recruiting

  • Sydney Cardiometabolic Centre

    Liverpool, New South Wales, 2170

    Recruiting

  • Hunter Diabetes Centre

    Merewether, New South Wales, 2291

    Recruiting

Other trials in Australia

About this study

Official title: 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.

Conditions
Obesity
Being tested
NNC0487-0111, Placebo (matched to NNC0487-0111)
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NNC0487-0111Drug

    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.

Study groups in NCT07339423
Study groupRoleWhat they receive
NNC0487-0111ExperimentalParticipants 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.
Receives: Drug: NNC0487-0111
PlaceboPlacebo comparatorParticipants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Receives: Drug: Placebo (matched to NNC0487-0111)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative change in body weight

    Measured as percentage of body weight.

    Measured: From baseline (week 0) to week 84

Secondary outcomes (24)

  1. Change in waist circumference

    Measured as centimetre (cm).

    Measured: From baseline (week 0) to week 84 and week 136

  2. Change in systolic blood pressure (SBP)

    Measured as millimetre of mercury (mmHg).

    Measured: From baseline (week 0) to week 84 and week 136

  3. Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score

    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.

    Measured: From baseline (week 0) to week 84 and week 136

  4. Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score

    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.

    Measured: From baseline (week 0) to week 84 and week 136

  5. Change in body weight

    Measured as kilogram (kg).

    Measured: From baseline (week 0) to week 84 and week 136

  6. Change in body mass index (BMI)

    Measured as kilograms per meter squared (kg/m^2).

    Measured: From baseline (week 0) to week 84 and week 136

  7. Change in IWQOL-Lite-CT physical composite score

    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.

    Measured: From baseline (week 0) to week 84 and week 136

  8. Change in IWQOL-Lite-CT psychosocial composite score

    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.

    Measured: From baseline (week 0) to week 84 and week 136

  9. Change in IWQOL-Lite-CT total score

    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.

    Measured: From baseline (week 0) to week 84 and week 136

  10. Change in glycated haemoglobin (HbA1c)

    Measured as percentage of HbA1c.

    Measured: From baseline (week 0) to week 84 and week 136

  11. Change in fasting plasma glucose (FPG)

    Measured as millimole per liter (mmol/L).

    Measured: From baseline (week 0) to week 84 and week 136

  12. Ratio to baseline: change in fasting insulin

    Measured as ratio.

    Measured: From baseline (week 0) to week 84 and week 136

  13. Change in diastolic blood pressure (DBP)

    Measured as mmHg.

    Measured: From baseline (week 0) to week 84

  14. Ratio to baseline: change in total cholesterol

    Measured as ratio.

    Measured: From baseline (week 0) to week 84 and week 136

  15. Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol

    Measured as ratio.

    Measured: From baseline (week 0) to week 84 and week 136

  16. Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol

    Measured as ratio.

    Measured: From baseline (week 0) to week 84 and week 136

  17. Ratio to baseline: change in very low-density lipoprotein (VLDL) cholesterol

    Measured as ratio.

    Measured: From baseline (week 0) to week 84 and week 136

  18. Ratio to baseline: change in non-HDL cholesterol

    Measured as ratio.

    Measured: From baseline (week 0) to week 84 and week 136

  19. Ratio to baseline: change in triglycerides

    Measured as ratio.

    Measured: From baseline (week 0) to week 84 and week 136

  20. Ratio to baseline: change in high-sensitivity C-reactive protein (hsCRP)

    Measured as ratio.

    Measured: From baseline (week 0) to week 84 and week 136

  21. Number of treatment emergent adverse events (TEAEs)

    Measured as events.

    Measured: From baseline (week 0) to week 84 and week 140

  22. Number of treatment emergent serious adverse events (TESAEs)

    Measured as events.

    Measured: From baseline (week 0) to week 84 and week 140

  23. Number of TEAEs leading to permanent treatment discontinuation

    Measured as events.

    Measured: From baseline (week 0) to week 84 and week 140

  24. Relative change in body weight

    Measured as % of body weight.

    Measured: From baseline (week 0) to week 136

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2026
  2. Study start24 Feb 2026
  3. Primary completion26 Jun 2029 (estimated)
  4. Study completion21 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07339423
Sponsor's protocol ID
NN9490-8021
Other IDs
U1111-1313-6262, 2024-520440-42
Acronym
AMAZE 1
Status last verified
Sep 2026
First submitted
13 Jan 2026
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NNC0487-0111 in people with Obesity, run by Novo Nordisk A/S at 72 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, United Kingdom, Argentina, Belgium, Denmark and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative change in body weight (time frame: From baseline (week 0) to week 84). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07339423.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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