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Diabetes MellitusPhase 3AMAZE 2NCT07533175

AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight

A Phase 3 study testing NNC0487-0111 in people with Diabetes Mellitus and Overweight, run by Novo Nordisk A/S at 73 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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 and type 2 diabetes. 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
Diabetes Mellitus, Overweight, 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
638 participants
Where
73 sitesin 10 countries
Study dates
13 Apr 2026to 7 Aug 2028
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).
  • Age 18 years or above at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus more than equal to (≥) 180 days before screening.
  • Treatment with lifestyle intervention, and/or 0-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) before screening.
  • Haemoglobin A1c (HbA1c) 7-10% [53-86 (millimoles per mole) mmol/mol] (both inclusive) as measured by the central laboratory at screening.

Who cannot join

  • Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than (<) 30 milliliter per minute per meter square (mL/min/1.73 m^2) [2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula], at screening.
  • Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) before screening or are expected to require treatment after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
  • Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
  • Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
  • 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

73 sites in 10 countries.

73 sites in 10 countries

United States15 sites

  • Univ of Alabama Birmingham

    Birmingham, Alabama, 35294

  • M3 Wake Research Chattanooga

    Chattanooga, Tennessee, 37421

  • UT Southwestern Med Center

    Dallas, Texas, 75390

  • Headlands Research California, LLC

    Escondido, California, 92025

  • Northeast Research Institute

    Fleming Island, Florida, 32003

  • PlanIt Research, PLLC

    Houston, Texas, 77079

  • Jacksonville Ctr Clin Res

    Jacksonville, Florida, 32216

  • Torrance Clinical Research Institute, Inc.

    Lomita, California, 90717

  • International Diabetes Center

    Minneapolis, Minnesota, 55416

  • Florida Institute for Clinical Research, LLC

    Orlando, Florida, 32825

  • Oviedo Medical Research, LLC

    Oviedo, Florida, 32765

  • National Clin Res Inc.

    Richmond, Virginia, 23294

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Southgate Medical Group, LLP

    West Seneca, New York, 14224

Other trials in United States

Romania9 sites

  • CMI Dr. Pletea Noemi SRL

    Bacau, 600154

  • SC Nutrilife SRL

    Bucharest, 013764

  • SC Clinica Diabnutrimed S.R.L.

    Bucharest, 020359

  • Diabet Med SRL

    Bucharest, 050913

  • Cmi Dr. Cojocaru Cristina

    Constanța, 900512

  • S.C. Top Diabet Srl

    Craiova, Dolj, 200515

  • A&C Medical Prime S.R.L.

    Craiova, 200692

  • Poli Cardinal Med Srl

    Reghin, Mureș County, 545300

  • Spital Judetean De Urgenta Satu Mare

    Satu Mare, 440055

Other trials in Romania

Croatia8 sites

  • Opca bolnica Karlovac

    Karlovac, 47000

  • Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology

    Krapinske Toplice, 49217

  • Specijalna bolnica Thalassotherapia

    Opatija, 51 410

  • Poliklinika SLAVONIJA OSIJEK

    Osijek, 31000

  • Opca bolnica Pula

    Pula, 52100

  • Poliklinika za oftalmologiju optometriju i neurologiju Lux

    Solin, 21210

  • Opca bolnica Varazdin_Endocrinology

    Varaždin, 42 000

  • Poliklinika Solmed

    Zagreb, 10000

Other trials in Croatia

Hungary8 sites

  • DRC Kft.

    Balatonfüred, 8230

  • Szent Margit Rendelőintézet Nonprofit Kft.

    Budapest, 1032

  • Semmelweis Egyetem

    Budapest, 1083

  • PVN Kutató Kft.

    Budapest, 1102

  • Észak-Pesti Centrumkórház Honvédkórház - Diabetológia Szakrendelés

    Budapest, 1134

  • Trantor 99 Bt

    Budapest, H-1213

  • Somogy Vármegyei Kaposi Mór Oktató Kórház

    Kaposvár, 7400

  • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ

    Szeged, Csongrád-Csanád, 6725

Other trials in Hungary

South Korea7 sites

  • Chonnam National University Hospital_Endocrinology

    Gwangju, 61469

  • Kyunghee University Medical Center_Endocrinology

    Seoul, 02447

  • Seoul National University Hospital_Endocrinology

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System_Endocrinology

    Seoul, 03722

  • Asan Medical Center_Endocrinology

    Seoul, 05505

  • The Catholic University of Korea, Yeouido ST. Mary's Hospital_Endocrinology

    Seoul, 07345

  • Seoul National University Bundang Hospital_Endocrinology

    Seoungnam-si, Gyeonggi-do, 13620

Other trials in South Korea

Italy6 sites

  • Dip. Med. Chir. delle malattie digestive, epatiche ed endo-meta - UOC Endocrinologia e prevenzione e cura del diabete

    Bologna, Emilia-Romagna, 40138

  • Grande Ospedale Metropolitano Niguarda - Dipartimento Medico Polispecialistico - Diabetologia

    Milan, Lombardy, 20159

  • IRCCS Ospedale San Raffaele Milano

    Milan, 20132

  • A.O.U Policlinico Paolo Giaccone - U.O.C Medicina Interna

    Palermo, Sicily, 90127

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - PSD Nutrizione Clinica, Obesità e Metabolismo

    Palermo, Sicily, 90127

  • Universita Degli Studi Di Roma La Sapienza - Policlinico Umberto I Medicina Sperimentale

    Rome, Lazio, 00161

Other trials in Italy

Mexico6 sites

  • Clinstile S.A. de C.V.

    Col Roma Norte, Mexico City, 06700

  • Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab

    Distrito Federal, México, D.F., 14080

  • Centro de Investigacion Clinica Endocrinologica de Jalisco

    Guadalajara, Jalisco, 44670

  • Centro de Investigación Clinica de Oaxaca (CICLO)

    Oaxaca City, Oaxaca, 68020

  • Consultorio de Endocrinología y Pediatría

    Puebla City, 72190

  • Unidad Medica para la Salud Integral (UMSI)

    San Nicolás de los Garza, Nuevo León, 66465

Other trials in Mexico

Slovakia6 sites

  • DIA - KONTROL s.r.o.

    Levice, 93401

  • Narodny Endokrinologicky a diabetologicky ustav

    Ľubochňa, 03491

  • OLIVER - MED s.r.o.

    Rimavská Sobota, 979 01

  • Peter Farkas MD, s.r.o.

    Šahy, 93601

  • DEImedi, s. r. o.

    Šurany, 942 01

  • ARETEUS s.r.o.

    Trebišov, 075 01

Other trials in Slovakia

Argentina4 sites

  • Kynet Recoleta

    Buenos Aires, C1119ACU

  • Centro médico privado Cemaic

    Córdoba, X5008

  • MICA- Medicina e Investigación Cardiometabólica

    Manuel Alberti, Buenos Aires, B1669

  • CEDIR - Centro de diagnóstico y rehabilitación Santa Fe

    Santa Fe, S3000FSO

Other trials in Argentina

Brazil4 sites

  • PUCCAMP - Hospital e Maternidade Celso Pierro

    Campinas, São Paulo, 13060-803

  • Cline Research Center

    Curitiba, Paraná, 80030-480

  • CPCLIN - Centro de Pesquisas Clínicas

    São Paulo, São Paulo, 01228-200

  • Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USP

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

About this study

Official title: Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Type 2 Diabetes (AMAZE 2)

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 and type 2 diabetes. 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 (treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Being tested
NNC0487-0111, Placebo (matched to NNC0487-0111)
Medical subject headings
Diabetes Mellitus, Overweight, 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 NCT07533175
Study groupRoleWhat they receive
NNC0487-0111 dose level 1ExperimentalParticipants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Receives: Drug: NNC0487-0111
NNC0487-0111 dose level 2ExperimentalParticipants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Receives: Drug: NNC0487-0111
NNC0487-0111 dose level 3ExperimentalParticipants will be randomized to receive NNC0487-0111 dose level 3 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Receives: Drug: NNC0487-0111
NNC0487-0111 dose level 4ExperimentalParticipants will be randomized to receive NNC0487-0111 dose level 4 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 (28)

  1. Change in waist circumference

    Measured as centimetre (cm).

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

  2. Change in glycated haemoglobin (HbA1c)

    Measured as percentage (%) of HbA1c.

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

  3. Change in systolic blood pressure (SBP)

    Measured as millimetre of mercury (mmHg).

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

  4. 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 functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. The physical function score ranges from 0-100. Higher scores indicate better levels of functioning.

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

  5. 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, that is transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation (SD) of 10. The physical functioning ranges from 19.0 to 57.6. Higher scores indicate better functional health and well-being.

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

  6. Change in body weight

    Measured as kilogram (kg).

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

  7. Change in body mass index (BMI)

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

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

  8. Change in IWQOL-Lite-CT: Physical, Psychosocial, 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. The physical function score ranges from 0-100. Higher scores indicate better levels of functioning.

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

  9. Achievement of HbA1c < 7.0% (Yes/No)

    Measured as number of participants

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

  10. Achievement of HbA1c ≤ 6.5% (Yes/No)

    Measured as number of participants

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

  11. Achievement of HbA1c < 5.7% (Yes/No)

    Measured as number of participants

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

  12. Change in fasting plasma glucose (FPG) (mmol/L)

    Measured as millimoles per liter (mmol/L)

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

  13. Change in fasting plasma glucose (FPG) (mg/dL)

    Measured as milligram per deciliter (mg/dL)

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

  14. Change in fasting insulin

    Measured as ratio to baseline.

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

  15. Change in urinary albumin-to-creatinine ratio (UACR)

    Measured as ratio to baseline.

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

  16. Change in diastolic blood pressure

    Measured as mmHg.

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

  17. Change in high-sensitivity C-reactive protein (hsCRP)

    Measured as ratio to baseline.

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

  18. Number of Treatment Emergent Adverse Events (TEAEs)

    Measured as count of events.

    Measured: From baseline (week 0) to week 88

  19. Number of Treatment Emergent Serious Adverse Events (TESAEs)

    Measured as count of events.

    Measured: From baseline (week 0) to week 88

  20. Number of Treatment Emergent Adverse Events (TEAEs) leading to permanent treatment discontinuation

    Measured as count of events.

    Measured: From baseline (week 0) to week 88

  21. Number of treatment emergent clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L (54 mg/dL), confirmed by a blood glucose (BG) meter)

    Measured as number of episodes

    Measured: From baseline (week 0) to week 88

  22. Number of treatment emergent severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold

    Measured as number of episodes

    Measured: From baseline (week 0) to week 88

  23. Change in Total cholesterol

    Measured as ratio to baseline.

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

  24. Change in High-density lipoprotein (HDL) cholesterol

    Measured as ratio to baseline.

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

  25. Change in Low-density lipoprotein (LDL) cholesterol

    Measured as ratio to baseline.

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

  26. Change in Very low-density lipoprotein (VLDL) cholesterol

    Measured as ratio to baseline.

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

  27. Change in Non-HDL cholesterol

    Measured as ratio to baseline.

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

  28. Change in Triglycerides

    Measured as ratio to baseline.

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

Timeline

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

  1. First posted16 Apr 2026
  2. Study start13 Apr 2026
  3. Primary completion7 Aug 2028 (estimated)
  4. Study completion7 Aug 2028 (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
638 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07533175
Sponsor's protocol ID
NN9490-8024
Other IDs
U1111-1313-6325, 2024-520441-23
Acronym
AMAZE 2
Status last verified
Nov 2026
First submitted
9 Apr 2026
Last updated
6 Nov 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 Diabetes Mellitus and Overweight, run by Novo Nordisk A/S at 73 sites in 10 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Romania, Croatia, Hungary, South Korea and 5 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT07533175.

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 6 Nov 2026.

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