ObesityPhase 3AMAZE 6NCT07509307
AMAZE 6: 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 Overweight, run by Novo Nordisk A/S at 81 sites in 11 countries.
Trial summary
This study is being done to look at the safety and effect of NNC0487-0111 in people with excess body weight and knee osteoarthritis when compared to placebo. 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, Overweight, Osteoarthritis, Knee
- 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
- 81 sitesin 11 countries
- Study dates
- 20 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 (OA) (American College of Rheumatology criteria) with radiographic changes (Kellgren Lawrence [KL] grades 2 to 4 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 > 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 grams (g)/day is allowed as rescue medication up until 24 hours before those visits)
Who cannot join
- Glycated haemoglobin (HbA1c) ≥ 6.5% (48 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
81 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
81 sites in 11 countries
United States19 sites, 19 recruiting
- Recruiting
Northwest Clinical Research Center
Bellevue, Washington, 98007
- Recruiting
Mercy Family Clinic
Dallas, Texas, 75208
- Recruiting
Neighborhood Healthcare
Escondido, California, 92025
- Recruiting
Clinical Investigation Spec Gurnee
Gurnee, Illinois, 60031
- Recruiting
Westside Center For Clinical Research
Jacksonville, Florida, 32205
- Recruiting
Clinical Neuroscience Solutions, LLC
Jacksonville, Florida, 32256
- Recruiting
First Valley Medical Group
Lancaster, California, 93534
- Recruiting
Monroe Biomedical Research, LLC
Louisville, Kentucky, 40213
- Recruiting
Advanced Res for Health Improve
Naples, Florida, 34102
- Not yet recruiting
NYU Langone Orthopedic Center
New York, New York, 10016
- Recruiting
Hospital For Special Surgery
New York, New York, 10021
- Recruiting
Health Res of Hampton Roads
Newport News, Virginia, 23606
- Recruiting
Desert Oasis Healthcare
Palm Springs, California, 92262
- Recruiting
Northwest Research Center
Portland, Oregon, 97202
- Recruiting
Evanston Premier Hlthcr Res
Skokie, Illinois, 60077
- Recruiting
Clinvest Research
Springfield, Missouri, 65807
- Recruiting
Piedmont Healthcare/Research
Statesville, North Carolina, 28625
- Recruiting
Arcturus Healthcare, PLC.
Troy, Michigan, 48098-6368
- Recruiting
Chase Medical Research LLC
Waterbury, Connecticut, 06708
Spain11 sites, 11 recruiting
- Recruiting
Instituto Medico Quirurgico San Rafael
A Coruña, 15006
- Recruiting
Hospital Germans Trias i Pujol
Badalona, 08916
- Recruiting
Hospital Naval Ferrol
Ferrol, 15405
- Not yet 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
Poland9 sites, 9 recruiting
- Recruiting
"Zdrowie Osteo-Medic" s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
Bialystok, Podlaskie Voivodeship, 15-351
- Recruiting
ClinicMed Daniluk, Nowak Spółka Komandytowa
Bialystok, 15-879
- Recruiting
Centrum Medyczne Intercor Sp. z o.o.
Bydgoszcz, 85-605
- Not yet recruiting
Centrum Medyczne Intercor Sp. z o.o.
Bydgoszcz, 85-605
- Recruiting
CenterMed Kraków Sp. z o.o.
Krakow, 31-530
- Not yet recruiting
CenterMed Kraków Sp. z o.o.
Krakow, 31-530
- Recruiting
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.
Krakow, 31-826
- Not yet recruiting
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.
Krakow, 31-826
- Recruiting
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
Warsaw, 02-637
Greece7 sites, 7 recruiting
- Recruiting
Evangelismos S.A. - Endocrinology department
Athens, 10676
- 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
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
Italy7 sites, 7 recruiting
- Recruiting
Auxologico San Luca - Endocrinologia e Malattie del Metabolismo
Milan, Lombardy, 20149
- Recruiting
Ospedale Galeazzi S.p.A. - INCO - Istituto Nazionale per la Cura dell'Obesità
Milan, Lombardy, 20157
- Recruiting
Casa della Salute di Ceccano - Ambulatori Campus Biomedico
Rome, Lazio, 00128
- 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
- Not yet recruiting
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento - U.O. Reumatologia
Verona, Veneto, 37126
Turkey (Türkiye)7 sites, 7 recruiting
- 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
SBÜ Ankara Gaziler Fizik Tedavi Ve Rehabilitasyon Eğitim Ve Araştırma Hastanesi
Çankaya/Ankara, 06800
- Recruiting
Trakya Üniversitesi Tıp Fakültesi Hastanesi-Fizik Tedavi ve Rehabilitasyon
Edirne, 22030
- Recruiting
Istanbul Üniversitesi- Istanbul Tıp Fakültesi Esnaf Hastanesi Poliklinikleri Fiziksel Tıp Ve Rehabilitasyon Anabilim Dalı
Fatih/İstanbul, 34116
- Recruiting
Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Fizik Tedavi ve Rehabilitasyon
Yıldırım/Bursa, 16310
- Recruiting
Adana Şehir Eğitim ve Araştırma Hastanesi-Fizik Tedavi ve Rehabilitasyon
Yuregir/Adana, 01060
Bulgaria6 sites, 6 recruiting
- 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
Canada6 sites, 6 recruiting
- Recruiting
ALPHA Recherche Clinique
Lévis, Quebec, G6V 0C9
- Recruiting
Centre Medical Acadie
Montreal, Quebec, H4N 2W2
- Recruiting
Your Research Network
Niagara Falls, Ontario, L2H 1H5
- Recruiting
ALPHA Recherche Clinique
Québec, Quebec, G3K 2P8
- Recruiting
Centre de Recherche du CHUS
Sherbrooke, Quebec, J1H 5N4
- Not yet recruiting
TLC Diabetes and Endocrinology
Surrey, British Columbia, V3T 2V6
Australia5 sites, 5 recruiting
- 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
Denmark3 sites, 3 recruiting
- 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
Puerto Rico1 site, 1 recruiting
- Recruiting
Latin Clinical Trial Center Puerto Rico
San Juan, 00909
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 6)
This study is being done to look at the safety and effect of NNC0487-0111 in people with excess body weight and knee osteoarthritis when compared to placebo. 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, Overweight, Osteoarthritis, Knee
- Being tested
- NNC0487-0111, Placebo (matched to NNC0487-0111)
- Medical subject headings
- Obesity, Overweight, 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 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 group | Role | What they receive |
|---|---|---|
| NNC0487-0111 | Experimental | Participants will be randomized to receive 1 of the 2 dose levels of NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. Receives: Drug: NNC0487-0111 |
| Placebo | Placebo comparator | Participants 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.
Relative change in body weight
Measured as percentage change in body weight.
Measured: From baseline (week 0) to week 80
Change in Western Ontario and McMaster Universities Osteoarthritis Index Numerical Rating Scale (NRS) 3.1 (24-hour) (WOMAC) pain score
WOMAC is a participant reported outcome (PRO) measures symptoms in the areas of pain, stiffness, and physical function in participants with osteoarthritis of the hip and/or knee. 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. Subscale score for pain ranges 0-100, where higher score indicates worse pain. Measured as score on a scale.
Measured: From baseline (week 0) to week 80
Secondary outcomes (27)
Change in WOMAC physical function score
WOMAC is a PRO measures symptoms in the areas of pain, stiffness, and physical function in participants with osteoarthritis of the hip and/or knee. 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. Subscale score for physical function ranges 0-100, where higher score indicates worse physical function. Measured as score on a scale.
Measured: From baseline (week 0) to week 80
Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score
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 as score on a scale.
Measured: From baseline (week 0) to week 80
Change in body weight
Measured as kilograms (kg).
Measured: From baseline (week 0) to week 80
Change in body mass index (BMI)
Measured as kilograms per meter squared (kg/m^2).
Measured: From baseline (week 0) to week 80
Change in WOMAC stiffness score
WOMAC is a PRO measures symptoms in the areas of pain, stiffness, and physical function in participants with osteoarthritis of the hip and/or knee. 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. Subscale score for stiffness ranges 0-100, where higher score indicates worse stiffness. Measured as score on a scale.
Measured: From baseline (week 0) to week 80
Change in WOMAC total score
WOMAC is a PRO measures symptoms in the areas of pain, stiffness, and physical function in participants with osteoarthritis of the hip and/or knee. 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. Total score ranges 0-100, where higher score indicates worse pain, stiffness, physical function and overall osteoarthritis related disability. Measured as score on a scale.
Measured: From baseline (week 0) to week 80
Change in waist circumference
Measured as centimetres (cm).
Measured: From baseline (week 0) to week 80
Change in systolic blood pressure (SBP)
Measured as millimetre of mercury (mmHg).
Measured: From baseline (week 0) to week 80
Change in diastolic blood pressure (DBP)
Measured as mmHg.
Measured: From baseline (week 0) to week 80
Ratio to baseline: change in total cholesterol
Measured as ratio.
Measured: From baseline (week 0) to week 80
Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol
Measured as ratio.
Measured: From baseline (week 0) to week 80
Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol
Measured as ratio.
Measured: From baseline (week 0) to week 80
Ratio to baseline: change in very low-density lipoprotein (VLDL) cholesterol
Measured as ratio.
Measured: From baseline (week 0) to week 80
Ratio to baseline: change in non-HDL cholesterol
Measured as ratio.
Measured: From baseline (week 0) to week 80
Ratio to baseline: change in triglycerides
Measured as ratio.
Measured: From baseline (week 0) to week 80
Ratio to baseline: change in high-sensitivity C-reactive protein (hsCRP)
Measured as ratio.
Measured: From baseline (week 0) to week 80
Change in glycated haemoglobin (HbA1c)
Measured as percentage of HbA1c.
Measured: From baseline (week 0) to week 80
Change in fasting plasma glucose (FPG)
Measured as millimole per litre (mmol/L).
Measured: From baseline (week 0) to week 80
Number of participants with use of allowed rescue analgesics during washout period (yes/no)
Measured as count of participants.
Measured: From baseline (week 0) to week 80
Amount of allowed rescue analgesics used during washout period
Measured as dose of analgesics.
Measured: From baseline (week 0) to week 80
Number of participants with use of pain medication (yes/no)
Measured as count of participants.
Measured: From baseline (week 0) to week 80
Amount of pain medication used
Measured as dose of pain medication.
Measured: From baseline (week 0) to week 80
Number of participants with change in pain medication (decrease/no change/increase)
Measured as count of participants.
Measured: From baseline (week 0) to week 80
Change in knee pain intensity score (NRS)
NRS item is PRO measures knee pain at its worst. 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 as score on a scale.
Measured: From baseline (week 0) to week 80
Number of treatment emergent adverse events (TEAEs)
Measured as events.
Measured: From baseline (week 0) to week 84
Number of treatment emergent serious adverse events (TESAEs)
Measured as events.
Measured: From baseline (week 0) to week 84
Number of TEAEs leading to permanent treatment discontinuation
Measured as 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.
- First posted3 Apr 2026
- Study start20 Apr 2026
- Primary completion14 Aug 2028 (estimated)
- Study completion14 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509307
- Sponsor's protocol ID
- NN9490-8294
- Other IDs
- U1111-1313-6954, 2024-520445-23
- Acronym
- AMAZE 6
- Status last verified
- Aug 2026
- First submitted
- 29 Mar 2026
- Last updated
- 17 Aug 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Knee Osteoarthritis (AMAZE 6)
- ClinicalTrials.gov ID
- NCT07509307
- Acronym / sponsor ID
- AMAZE 6 / NN9490-8294
- Conditions
- Obesity, Overweight, Osteoarthritis, Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 14 Aug 2028 (estimated)
- Study completion
- 14 Aug 2028 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to look at the safety and effect of NNC0487-0111 in people with excess body weight and knee osteoarthritis when compared to placebo. 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC0487-0111 | Experimental | Drug: NNC0487-0111Participants will be randomized to receive 1 of the 2 dose levels of NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| Placebo | Placebo comparator | Drug: Placebo (matched to NNC0487-0111)Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female (sex at birth)
- Age 18 years or above at the time of signing the informed consent
- Clinical diagnosis of knee osteoarthritis (OA) (American College of Rheumatology criteria) with radiographic changes (Kellgren Lawrence [KL] grades 2 to 4 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 > 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 grams (g)/day is allowed as rescue medication up until 24 hours before those visits)
Key exclusion criteria (6 listed)
- Glycated haemoglobin (HbA1c) ≥ 6.5% (48 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC0487-0111NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. | Drug | NNC0487-0111 |
| 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. | Drug | Placebo |
Primary outcome
Relative change in body weight
Time frame: From baseline (week 0) to week 80
Measured as percentage change in body weight.
Change in Western Ontario and McMaster Universities Osteoarthritis Index Numerical Rating Scale (NRS) 3.1 (24-hour) (WOMAC) pain score
Time frame: From baseline (week 0) to week 80
WOMAC is a participant reported outcome (PRO) measures symptoms in the areas of pain, stiffness, and physical function in participants with osteoarthritis of the hip and/or knee. 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. Subscale score for pain ranges 0-100, where higher score indicates worse pain. Measured as score on a scale.
27 secondary outcomes
Change in WOMAC physical function score
Time frame: From baseline (week 0) to week 80
Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score
Time frame: From baseline (week 0) to week 80
Change in body weight
Time frame: From baseline (week 0) to week 80
Change in body mass index (BMI)
Time frame: From baseline (week 0) to week 80
Change in WOMAC stiffness score
Time frame: From baseline (week 0) to week 80
Change in WOMAC total score
Time frame: From baseline (week 0) to week 80
Change in waist circumference
Time frame: From baseline (week 0) to week 80
Change in systolic blood pressure (SBP)
Time frame: From baseline (week 0) to week 80
Change in diastolic blood pressure (DBP)
Time frame: From baseline (week 0) to week 80
Ratio to baseline: change in total cholesterol
Time frame: From baseline (week 0) to week 80
Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol
Time frame: From baseline (week 0) to week 80
Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol
Time frame: From baseline (week 0) to week 80
Ratio to baseline: change in very low-density lipoprotein (VLDL) cholesterol
Time frame: From baseline (week 0) to week 80
Ratio to baseline: change in non-HDL cholesterol
Time frame: From baseline (week 0) to week 80
Ratio to baseline: change in triglycerides
Time frame: From baseline (week 0) to week 80
Ratio to baseline: change in high-sensitivity C-reactive protein (hsCRP)
Time frame: From baseline (week 0) to week 80
Change in glycated haemoglobin (HbA1c)
Time frame: From baseline (week 0) to week 80
Change in fasting plasma glucose (FPG)
Time frame: From baseline (week 0) to week 80
Number of participants with use of allowed rescue analgesics during washout period (yes/no)
Time frame: From baseline (week 0) to week 80
Amount of allowed rescue analgesics used during washout period
Time frame: From baseline (week 0) to week 80
Number of participants with use of pain medication (yes/no)
Time frame: From baseline (week 0) to week 80
Amount of pain medication used
Time frame: From baseline (week 0) to week 80
Number of participants with change in pain medication (decrease/no change/increase)
Time frame: From baseline (week 0) to week 80
Change in knee pain intensity score (NRS)
Time frame: From baseline (week 0) to week 80
Number of treatment emergent adverse events (TEAEs)
Time frame: From baseline (week 0) to week 84
Number of treatment emergent serious adverse events (TESAEs)
Time frame: From baseline (week 0) to week 84
Number of TEAEs leading to permanent treatment discontinuation
Time frame: From baseline (week 0) to week 84
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
81 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NNC0487-0111 in people with Obesity and Overweight, run by Novo Nordisk A/S at 81 sites in 11 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 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 sites in United States, Spain, Poland, Greece, Italy and 6 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?
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 17 Aug 2026.