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ObesityPhase 3AMAZE 5NCT07481630

A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain

A Phase 3 study testing NNC0487-0111 in people with Obesity and Knee Osteoarthritis (OA), run by Novo Nordisk A/S at 82 sites in 10 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 and knee osteoarthritis. 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, Knee Osteoarthritis (OA)
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
400 participants
Where
82 sitesin 10 countries
Study dates
13 Apr 2026to 14 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 the informed consent.
  • Clinical diagnosis of knee osteoarthritis (American College of Rheumatology criteria) with radiographic changes (Kellgren Lawrence (KL) grades 2 to 3 as per central reading) in target knee. Target knee joint is defined as most symptomatic knee at screening. If pain in knees is equal, the target knee joint will be the dominant leg.
  • Symptomatic knee OA with first appearance of pain in the target knee more than (>) 90 days prior to screening and pain in the target knee for > 15 days over the prior 30 days.
  • Willingness to complete a 72-hour washout period of analgesics before all visits involving WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) questionnaire (acetaminophen 4 gram (g)/day is allowed as rescue medication up until 24 hours before those visits).

Who cannot join

  • Glycated haemoglobin more than or equal to (≥) 6.5% [(48 millimoles 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.
  • Any joint prosthesis or joint replacement in target knee.
  • Arthroscopy or injections into target knee within the last 90 days prior to screening.
  • Any other joint disease in target knee including gout and pseudogout.

Trial locations and contacts

82 sites in 10 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

82 sites in 10 countries

United States19 sites, 19 recruiting

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

    Recruiting

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221

    Recruiting

  • Charlottesville Med Research

    Charlottesville, Virginia, 22911

    Recruiting

  • Hope Clin Res & Wellness

    Conyers, Georgia, 30094

    Recruiting

  • CenExel iResearch, LLC

    Decatur, Georgia, 30030

    Recruiting

  • Chase Medical Research LLC

    Hamden, Connecticut, 06517

    Recruiting

  • Zenith clinical research

    Hollywood, Florida, 33021

    Recruiting

  • CNS Healthcare

    Jacksonville, Florida, 32256

    Recruiting

  • Jubilee Clinical Research, Inc.

    Las Vegas, Nevada, 89106

    Recruiting

  • Angels Clinical Research Institute

    Miami Lakes, Florida, 33016

    Recruiting

  • Health Res of Hampton Roads

    Newport News, Virginia, 23606

    Recruiting

  • Coastal Carolina Res Ctr

    North Charleston, South Carolina, 29405

    Recruiting

  • Arizona Research Center, Inc.

    Phoenix, Arizona, 85053

    Recruiting

  • VIP Trials_San Antonio

    San Antonio, Texas, 78230

    Recruiting

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

    Recruiting

  • MedVadis Research Watertown

    Waltham, Massachusetts, 02451

    Recruiting

  • Chase Medical Research LLC

    Waterbury, Connecticut, 06708

    Recruiting

  • Great Lakes Medical Research

    Westfield, New York, 14787

    Recruiting

  • Accellacare and KDCILM, LLC

    Wilmington, North Carolina, 28401

    Recruiting

Other trials in United States

Poland12 sites, 12 recruiting

  • "Zdrowie Osteo-Medic" s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik

    Bialystok, Podlaskie Voivodeship, 15-351

    Recruiting

  • "Zdrowie Osteo-Medic" s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik

    Bialystok, Podlaskie Voivodeship, 15-351

    Not yet recruiting

  • ClinicMed Daniluk, Nowak Spółka Komandytowa

    Bialystok, 15-879

    Recruiting

  • ClinicMed Daniluk, Nowak Spółka Komandytowa

    Bialystok, 15-879

    Not yet recruiting

  • Centrum Medyczne Intercor Sp. z o.o.

    Bydgoszcz, 85-605

    Recruiting

  • Centrum Medyczne Intercor Sp. z o.o.

    Bydgoszcz, 85-605

    Not yet recruiting

  • CenterMed Kraków Sp. z o.o.

    Krakow, 31-530

    Recruiting

  • CenterMed Kraków Sp. z o.o.

    Krakow, 31-530

    Not yet recruiting

  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.

    Krakow, 31-826

    Recruiting

  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.

    Krakow, 31-826

    Not yet recruiting

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher

    Warsaw, 02-637

    Recruiting

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher

    Warsaw, 02-637

    Not yet recruiting

Other trials in Poland

Spain11 sites, 11 recruiting

  • Instituto Medico Quirurgico San Rafael

    A Coruña, 15006

    Recruiting

  • Hospital Germans Trias i Pujol

    Badalona, 08916

    Not yet recruiting

  • Hospital Naval Ferrol

    Ferrol, 15405

    Recruiting

  • Centro Especialidades Hermanos Sangro

    Madrid, 28038

    Recruiting

  • Hospital Quirónsalud Málaga

    Málaga, 29004

    Recruiting

  • Hospital Infanta Sofía

    San Sebastián de Los Reyes (Madrid), 28702

    Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

    Recruiting

  • Hospital HM La Esperanza

    Santiago de Compostela, 15705

    Recruiting

  • Clínica Nuevas Tecnologías en Diabetes y Endocrinología

    Seville, 41003

    Recruiting

  • H. Infanta Luisa_Endocrino y Obesidad

    Seville, 41010

    Recruiting

  • Hospital General de Valencia

    Valencia, 46014

    Recruiting

Other trials in Spain

Greece7 sites, 7 recruiting

  • Laiko General Hospital Of Athens - 1st department of Internal Medicine

    Athens, 115 27

    Recruiting

  • Athens Medical Center S.A. (Iatriko Psychikou) - Department of Internal Medicine & Metabolic Diseases

    Athens, 11525

    Recruiting

  • General Hospital Of Athens Alexandra - Clinical Therapeutics

    Athens, 11528

    Recruiting

  • University General Hospital Attikon General Hospital Of West Attica H Agia Varvara - 2nd dept of Internal medicine

    Chaïdári, Attica, 12461

    Recruiting

  • Athens Medical Center S.A. (Iatriko Athinon) - Diabetes and Obesity Unit

    Marousi, 15125

    Recruiting

  • NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes

    Thessaloniki, 54635

    Recruiting

  • Thermi Clinic S.A. - Diabetes and Internal Medicine Department

    Thessaloniki, 57001

    Recruiting

Other trials in Greece

Italy7 sites, 7 recruiting

  • Auxologico San Luca - Endocrinologia e Malattie del Metabolismo

    Milan, Lombardy, 20149

    Recruiting

  • Ospedale Civile di Baggiovara - UOC Endocrinologia

    Modena, Emilia-Romagna, 41126

    Not yet recruiting

  • AOU Federico II Di Napoli - DAI Endocr. Diab. Andro. e Nutr. - UOC Medicina Interna e Nutrizione Clinica

    Naples, Campania, 80131

    Recruiting

  • Pol. Uni. Campus Biomedico - UOC Endocrinologia e Diabetologia

    Rome, Lazio, 00128

    Recruiting

  • Policlinico San Donato di Milano S.p.A - UOS Endocrinologia e del Servizio di Nutrizione Clinica e Prevenzione Cardiometabolica

    San Donato Milanese, Lombardy, 20097

    Recruiting

  • Ospedale S. Maria della Misericordia - Reparto Endocrinologia e Malattie del Metabolismo

    Udine, Friuli Venezia Giulia, 33100

    Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento - U.O. Reumatologia

    Verona, Veneto, 37126

    Recruiting

Other trials in Italy

Turkey (Türkiye)7 sites, 7 recruiting

  • Ankara Üniversitesi Sağlık Uygulama ve Araştırma Hastaneleri- Fiziksel Tıp ve Rehabilitasyon

    Altındağ/Ankara, 06230

    Recruiting

  • İstanbul Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi

    Bahçelievler/İstanbul, 34186

    Recruiting

  • Ankara Bilkent Şehir Hastanesi- Fizik Tedavi ve Rehabilitasyon

    Çankaya/Ankara, 06800

    Recruiting

  • Çanakkale Onsekiz Mart Üniversitesi Sağlık Araştırma ve Uygulama Hastanesi-Fiziksel Tıp ve Rehabilitasyon

    Kepez/Çanakkale Merkez/Çanakkale, 17110

    Recruiting

  • İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi-Fiziksel Tıp ve Rehabilitasyon

    Merkez/Battalgazi/Malatya, 44280

    Recruiting

  • Karadeniz Teknik Üniversitesi Farabi Hastanesi- Fiziksel Tıp ve Rehabilitasyon

    Trabzon Merkez/Ortahisar/Trabzon, 61080

    Recruiting

  • Adana Şehir Eğitim ve Araştırma Hastanesi-Fizik Tedavi ve Rehabilitasyon

    Yuregir/Adana, 01060

    Recruiting

Other trials in Turkey (Türkiye)

Bulgaria6 sites, 6 recruiting

  • UMHAT Sveti Georgi EAD, Plovdiv

    Plovdiv, 4002

    Recruiting

  • MC Dr. Atanasov EOOD

    Sofia, 1231

    Recruiting

  • MC Excelsior OOD

    Sofia, 1407

    Recruiting

  • UMHAT Tsaritsa Yoanna - ISUL EAD, Orthopaedics and Traumatology

    Sofia, 1527

    Recruiting

  • MMA MHAT - Sofia, Rheumatology clinic

    Sofia, 1606

    Recruiting

  • UMHAT Sveti Ivan Rilski EAD, Rheumatology

    Sofia, 1612

    Recruiting

Other trials in Bulgaria

Australia5 sites, 5 recruiting

  • Emeritus Research Sydney

    Botany, New South Wales, 2019

    Recruiting

  • Heart of Australia

    Chelmer, Queensland, 4068

    Recruiting

  • Momentum Clinical Research Darlinghurst

    Darlinghurst, New South Wales, 2010

    Recruiting

  • Coastal Digestive Health

    Maroochydore, Queensland, 4558

    Recruiting

  • Kolling Institute

    St Leonards, New South Wales, 2065

    Recruiting

Other trials in Australia

Canada5 sites, 5 recruiting

  • Laser Rejuvenation Clinics Inc.

    Calgary, Alberta, T2W 4X9

    Recruiting

  • Dawson Clinical Research

    Guelph, Ontario, N1H 1B1

    Recruiting

  • Hamilton Medical Rsrch Grp

    Hamilton, Ontario, L8L 5G4

    Not yet recruiting

  • Alpha Recherche Clinique - Lebourgneuf

    Québec, G2J OC4

    Recruiting

  • Centre de Recherche Musculo

    Trois-Rivières, Quebec, G8Z 1Y2

    Recruiting

Other trials in Canada

Denmark3 sites, 3 recruiting

  • Aarhus Universitetshospital - Klinik for Led og bindevævssygdomme

    Aarhus N, 8200

    Recruiting

  • Frederiksberg Hospital - Parker Institutet (Artrose)

    Frederiksberg, 2000

    Recruiting

  • Sanos Clinic - Herlev

    Herlev, 2730

    Recruiting

Other trials in Denmark

About this study

Official title: Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Knee Osteoarthritis (AMAZE 5)

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 knee osteoarthritis. 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.

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

What participants receive

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

  • NNC0487-0111Drug

    NNC0487-0111 dose level 1 and dose level 2 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 NCT07481630
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
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 80)

  2. Change in WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) pain score

    Measured as score on a scale. Western Ontario and McMaster Universities Arthritis Index (WOMAC) measures symptoms in the areas of pain, stiffness, and physical function. The measure consists of 24 items yielding 3 subscale scores and 1 total score. WOMAC raw scores are transformed to a standardised 0 to 100 score range. Higher scores indicate worse pain, stiffness, physical function, and overall osteoarthritis- related disability.

    Measured: From baseline (week 0) to (week 80)

Secondary outcomes (27)

  1. Change in WOMAC physical function score

    Measured as score on a scale. Physical function score will be calculated according to the guidelines provided in the WOMAC User Guide XI. Score ranges from 0-100 and higher scores indicate worse physical function.

    Measured: From baseline (week 0) to (week 80)

  2. 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. 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 80)

  3. Change in body weight

    Measured as kilogram (kg).

    Measured: From baseline (week 0) to (week 80)

  4. Change in body mass index (BMI)

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

    Measured: From baseline (week 0) to (week 80)

  5. Change in WOMAC stiffness score

    Measured as score on a scale. Stiffness score will be calculated according to the guidelines provided in the WOMAC User Guide XI. Score ranges from 0-100 and higher scores indicate worse stiffness.

    Measured: From baseline (week 0) to (week 80)

  6. Change in WOMAC total score

    Measured as score on a scale. Total score will be calculated according to the guidelines provided in the WOMAC User Guide XI. Total score ranges from 0-100 and higher scores indicate worse overall osteoarthritis- related disability.

    Measured: From baseline (week 0) to (week 80)

  7. Change in waist circumference

    Measured as centimetre (cm).

    Measured: From baseline (week 0) to (week 80)

  8. Change in systolic blood pressure (SBP)

    Measured as millimetre of mercury (mmHg).

    Measured: From baseline (week 0) to (week 80)

  9. Change in diastolic blood pressure (DBP)

    Measured as mmHg.

    Measured: From baseline (week 0) to (week 80)

  10. Change in total cholesterol

    Measured as ratio to baseline.

    Measured: From baseline (week 0) to (week 80)

  11. Change in high-density lipoprotein (HDL) cholesterol

    Measured as ratio to baseline.

    Measured: From baseline (week 0) to (week 80)

  12. Change in low-density lipoprotein (LDL) cholesterol

    Measured as ratio to baseline.

    Measured: From baseline (week 0) to (week 80)

  13. Change in very low-density lipoprotein (VLDL) cholesterol

    Measured as ratio to baseline.

    Measured: From baseline (week 0) to (week 80)

  14. Change in non-HDL cholesterol

    Measured as ratio to baseline.

    Measured: From baseline (week 0) to (week 80)

  15. Change in triglycerides

    Measured as ratio to baseline.

    Measured: From baseline (week 0) to (week 80)

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

    Measured as ratio to baseline.

    Measured: From baseline (week 0) to (week 80)

  17. Change in glycated haemoglobin (HbA1c)

    Measured as percentage (%) of HbA1c.

    Measured: From baseline (week 0) to (week 80)

  18. Change in fasting plasma glucose (FPG)

    Measured as millimole per liter (mmol/L).

    Measured: From baseline (week 0) to (week 80)

  19. Number of participants allowed using rescue analgesics during washout period (Yes/no)

    Measured as number of participants

    Measured: From baseline (week 0) to (week 80)

  20. Amount of allowed rescue analgesics used during washout period

    Measured as dose of analgesics.

    Measured: From baseline (week 0) to (week 80)

  21. Use of pain medication (Yes/No)

    Measured as number of participants.

    Measured: From baseline (week 0) to (week 80)

  22. Amount of pain medication used

    Measured as dose of pain medication.

    Measured: From baseline (week 0) to (week 80)

  23. Number of participants with change in pain medication (decrease/no change/increase)

    Measured as number of participants.

    Measured: From baseline (week 0) to (week 80)

  24. Change in knee pain intensity (NRS)

    Measured as score on a scale. Knee pain numerical rating scale (NRS) measures knee pain at its worst in the last 24 hours. The measure consists of 1 item. The response scale is an 11-point numeric rating scale from 0 (No knee pain) to 10 (Worst possible knee pain). Higher scores indicate worse pain.

    Measured: From baseline (week 0) to (week 80)

  25. Number of treatment Emergent Adverse Events (TEAEs)

    Measured as number of events.

    Measured: From baseline (week 0) to week 84

  26. Number of treatment Emergent Serious Adverse Events (TESAEs)

    Measured as number of events.

    Measured: From baseline (week 0) to week 84

  27. Number of TEAEs leading to permanent treatment discontinuation

    Measured as number of events.

    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 posted19 Mar 2026
  2. Study start13 Apr 2026
  3. Primary completion14 Aug 2028 (estimated)
  4. Study completion14 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
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07481630
Sponsor's protocol ID
NN9490-8026
Other IDs
U1111-1313-6585, 2024-520444-42
Acronym
AMAZE 5
Status last verified
Jul 2026
First submitted
13 Mar 2026
Last updated
9 Jul 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 and Knee Osteoarthritis (OA), run by Novo Nordisk A/S at 82 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 6 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 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Poland, Spain, Greece, Italy 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?

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 80)). The study lists 2 primary outcomes in all. 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 NCT07481630.

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 9 Jul 2026.

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