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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1313-6585 | Other Identifier | World Health Organization (WHO) | |
| 2024-520444-42 | Other Identifier | European Medical Agency (EMA) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0487-0111 dose level 1 | Experimental | Participants 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. |
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| NNC0487-0111 dose level 2 | Experimental | Participants 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0487-0111 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | Measured as percentage (%) of body weight. | From baseline (week 0) to (week 80) |
| 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. | From baseline (week 0) to (week 80) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline (week 0) to (week 80) |
| Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score |
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Key inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Research Center, Inc. | Recruiting | Phoenix | Arizona | 85053 | United States | |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| 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. |
|
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. |
| From baseline (week 0) to (week 80) |
| Change in body weight | Measured as kilogram (kg). | From baseline (week 0) to (week 80) |
| Change in body mass index (BMI) | Measured as kilograms per meter squared (kg/m^2). | From baseline (week 0) to (week 80) |
| 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. | From baseline (week 0) to (week 80) |
| 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. | From baseline (week 0) to (week 80) |
| Change in waist circumference | Measured as centimetre (cm). | From baseline (week 0) to (week 80) |
| Change in systolic blood pressure (SBP) | Measured as millimetre of mercury (mmHg). | From baseline (week 0) to (week 80) |
| Change in diastolic blood pressure (DBP) | Measured as mmHg. | From baseline (week 0) to (week 80) |
| Change in total cholesterol | Measured as ratio to baseline. | From baseline (week 0) to (week 80) |
| Change in high-density lipoprotein (HDL) cholesterol | Measured as ratio to baseline. | From baseline (week 0) to (week 80) |
| Change in low-density lipoprotein (LDL) cholesterol | Measured as ratio to baseline. | From baseline (week 0) to (week 80) |
| Change in very low-density lipoprotein (VLDL) cholesterol | Measured as ratio to baseline. | From baseline (week 0) to (week 80) |
| Change in non-HDL cholesterol | Measured as ratio to baseline. | From baseline (week 0) to (week 80) |
| Change in triglycerides | Measured as ratio to baseline. | From baseline (week 0) to (week 80) |
| Change in high-sensitivity C-reactive protein (hsCRP) | Measured as ratio to baseline. | From baseline (week 0) to (week 80) |
| Change in glycated haemoglobin (HbA1c) | Measured as percentage (%) of HbA1c. | From baseline (week 0) to (week 80) |
| Change in fasting plasma glucose (FPG) | Measured as millimole per liter (mmol/L). | From baseline (week 0) to (week 80) |
| Number of participants allowed using rescue analgesics during washout period (Yes/no) | Measured as number of participants | From baseline (week 0) to (week 80) |
| Amount of allowed rescue analgesics used during washout period | Measured as dose of analgesics. | From baseline (week 0) to (week 80) |
| Use of pain medication (Yes/No) | Measured as number of participants. | From baseline (week 0) to (week 80) |
| Amount of pain medication used | Measured as dose of pain medication. | From baseline (week 0) to (week 80) |
| Number of participants with change in pain medication (decrease/no change/increase) | Measured as number of participants. | From baseline (week 0) to (week 80) |
| 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. | From baseline (week 0) to (week 80) |
| Number of treatment Emergent Adverse Events (TEAEs) | Measured as number of events. | From baseline (week 0) to week 84 |
| Number of treatment Emergent Serious Adverse Events (TESAEs) | Measured as number of events. | From baseline (week 0) to week 84 |
| Number of TEAEs leading to permanent treatment discontinuation | Measured as number of events. | From baseline (week 0) to week 84 |
| Diablo Clinical Research, Inc. |
| Recruiting |
| Walnut Creek |
| California |
| 94598 |
| United States |
| Chase Medical Research LLC | Recruiting | Hamden | Connecticut | 06517 | United States |
| Chase Medical Research LLC | Recruiting | Waterbury | Connecticut | 06708 | United States |
| Zenith clinical research | Recruiting | Hollywood | Florida | 33021 | United States |
| CNS Healthcare | Recruiting | Jacksonville | Florida | 32256 | United States |
| Angels Clinical Research Institute | Recruiting | Miami Lakes | Florida | 33016 | United States |
| Hope Clin Res & Wellness | Recruiting | Conyers | Georgia | 30094 | United States |
| CenExel iResearch, LLC | Recruiting | Decatur | Georgia | 30030 | United States |
| Elite Clinical Trials | Recruiting | Blackfoot | Idaho | 83221 | United States |
| MedVadis Research Watertown | Recruiting | Waltham | Massachusetts | 02451 | United States |
| Jubilee Clinical Research, Inc. | Recruiting | Las Vegas | Nevada | 89106 | United States |
| Great Lakes Medical Research | Recruiting | Westfield | New York | 14787 | United States |
| Accellacare and KDCILM, LLC | Recruiting | Wilmington | North Carolina | 28401 | United States |
| Coastal Carolina Res Ctr | Recruiting | North Charleston | South Carolina | 29405 | United States |
| VIP Trials_San Antonio | Recruiting | San Antonio | Texas | 78230 | United States |
| Charlottesville Med Research | Recruiting | Charlottesville | Virginia | 22911 | United States |
| Health Res of Hampton Roads | Recruiting | Newport News | Virginia | 23606 | United States |
| Northwest Clinical Research Center | Recruiting | Bellevue | Washington | 98007 | United States |
| Emeritus Research Sydney | Recruiting | Botany | New South Wales | 2019 | Australia |
| Momentum Clinical Research Darlinghurst | Recruiting | Darlinghurst | New South Wales | 2010 | Australia |
| Kolling Institute | Recruiting | St Leonards | New South Wales | 2065 | Australia |
| Heart of Australia | Recruiting | Chelmer | Queensland | 4068 | Australia |
| Coastal Digestive Health | Recruiting | Maroochydore | Queensland | 4558 | Australia |
| UMHAT Sveti Georgi EAD, Plovdiv | Recruiting | Plovdiv | 4002 | Bulgaria |
| MC Dr. Atanasov EOOD | Recruiting | Sofia | 1231 | Bulgaria |
| MC Excelsior OOD | Recruiting | Sofia | 1407 | Bulgaria |
| UMHAT Tsaritsa Yoanna - ISUL EAD, Orthopaedics and Traumatology | Recruiting | Sofia | 1527 | Bulgaria |
| MMA MHAT - Sofia, Rheumatology clinic | Recruiting | Sofia | 1606 | Bulgaria |
| UMHAT Sveti Ivan Rilski EAD, Rheumatology | Recruiting | Sofia | 1612 | Bulgaria |
| Laser Rejuvenation Clinics Inc. | Recruiting | Calgary | Alberta | T2W 4X9 | Canada |
| Dawson Clinical Research | Recruiting | Guelph | Ontario | N1H 1B1 | Canada |
| Hamilton Medical Rsrch Grp | Not yet recruiting | Hamilton | Ontario | L8L 5G4 | Canada |
| Centre de Recherche Musculo | Recruiting | Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Alpha Recherche Clinique - Lebourgneuf | Recruiting | Québec | G2J OC4 | Canada |
| Aarhus Universitetshospital - Klinik for Led og bindevævssygdomme | Recruiting | Aarhus N | 8200 | Denmark |
| Frederiksberg Hospital - Parker Institutet (Artrose) | Recruiting | Frederiksberg | 2000 | Denmark |
| Sanos Clinic - Herlev | Recruiting | Herlev | 2730 | Denmark |
| University General Hospital Attikon General Hospital Of West Attica H Agia Varvara - 2nd dept of Internal medicine | Recruiting | Chaïdári | Attica | 12461 | Greece |
| Laiko General Hospital Of Athens - 1st department of Internal Medicine | Recruiting | Athens | 115 27 | Greece |
| Athens Medical Center S.A. (Iatriko Psychikou) - Department of Internal Medicine & Metabolic Diseases | Recruiting | Athens | 11525 | Greece |
| General Hospital Of Athens Alexandra - Clinical Therapeutics | Recruiting | Athens | 11528 | Greece |
| Athens Medical Center S.A. (Iatriko Athinon) - Diabetes and Obesity Unit | Recruiting | Marousi | 15125 | Greece |
| NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes | Recruiting | Thessaloniki | 54635 | Greece |
| Thermi Clinic S.A. - Diabetes and Internal Medicine Department | Recruiting | Thessaloniki | 57001 | Greece |
| AOU Federico II Di Napoli - DAI Endocr. Diab. Andro. e Nutr. - UOC Medicina Interna e Nutrizione Clinica | Recruiting | Naples | Campania | 80131 | Italy |
| Ospedale Civile di Baggiovara - UOC Endocrinologia | Not yet recruiting | Modena | Emilia-Romagna | 41126 | Italy |
| Ospedale S. Maria della Misericordia - Reparto Endocrinologia e Malattie del Metabolismo | Recruiting | Udine | Friuli Venezia Giulia | 33100 | Italy |
| Pol. Uni. Campus Biomedico - UOC Endocrinologia e Diabetologia | Recruiting | Rome | Lazio | 00128 | Italy |
| Auxologico San Luca - Endocrinologia e Malattie del Metabolismo | Recruiting | Milan | Lombardy | 20149 | Italy |
| Policlinico San Donato di Milano S.p.A - UOS Endocrinologia e del Servizio di Nutrizione Clinica e Prevenzione Cardiometabolica | Recruiting | San Donato Milanese | Lombardy | 20097 | Italy |
| Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento - U.O. Reumatologia | Recruiting | Verona | Veneto | 37126 | Italy |
| "Zdrowie Osteo-Medic" s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik | Recruiting | Bialystok | Podlaskie Voivodeship | 15-351 | Poland |
| "Zdrowie Osteo-Medic" s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik | Not yet recruiting | Bialystok | Podlaskie Voivodeship | 15-351 | Poland |
| ClinicMed Daniluk, Nowak Spółka Komandytowa | Recruiting | Bialystok | 15-879 | Poland |
| ClinicMed Daniluk, Nowak Spółka Komandytowa | Not yet recruiting | Bialystok | 15-879 | Poland |
| Centrum Medyczne Intercor Sp. z o.o. | Recruiting | Bydgoszcz | 85-605 | Poland |
| Centrum Medyczne Intercor Sp. z o.o. | Not yet recruiting | Bydgoszcz | 85-605 | Poland |
| CenterMed Kraków Sp. z o.o. | Recruiting | Krakow | 31-530 | Poland |
| CenterMed Kraków Sp. z o.o. | Not yet recruiting | Krakow | 31-530 | Poland |
| Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. | Recruiting | Krakow | 31-826 | Poland |
| Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. | Not yet recruiting | Krakow | 31-826 | Poland |
| Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher | Recruiting | Warsaw | 02-637 | Poland |
| Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher | Not yet recruiting | Warsaw | 02-637 | Poland |
| Instituto Medico Quirurgico San Rafael | Recruiting | A Coruña | 15006 | Spain |
| Hospital Germans Trias i Pujol | Not yet recruiting | Badalona | 08916 | Spain |
| Hospital Naval Ferrol | Recruiting | Ferrol | 15405 | Spain |
| Centro Especialidades Hermanos Sangro | Recruiting | Madrid | 28038 | Spain |
| Hospital Quirónsalud Málaga | Recruiting | Málaga | 29004 | Spain |
| Hospital Infanta Sofía | Recruiting | San Sebastián de Los Reyes (Madrid) | 28702 | Spain |
| Hospital Universitario Marqués de Valdecilla | Recruiting | Santander | 39008 | Spain |
| Hospital HM La Esperanza | Recruiting | Santiago de Compostela | 15705 | Spain |
| Clínica Nuevas Tecnologías en Diabetes y Endocrinología | Recruiting | Seville | 41003 | Spain |
| H. Infanta Luisa_Endocrino y Obesidad | Recruiting | Seville | 41010 | Spain |
| Hospital General de Valencia | Recruiting | Valencia | 46014 | Spain |
| Ankara Üniversitesi Sağlık Uygulama ve Araştırma Hastaneleri- Fiziksel Tıp ve Rehabilitasyon | Recruiting | Altındağ/Ankara | 06230 | Turkey (Türkiye) |
| İstanbul Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi | Recruiting | Bahçelievler/İstanbul | 34186 | Turkey (Türkiye) |
| Ankara Bilkent Şehir Hastanesi- Fizik Tedavi ve Rehabilitasyon | Recruiting | Çankaya/Ankara | 06800 | Turkey (Türkiye) |
| Çanakkale Onsekiz Mart Üniversitesi Sağlık Araştırma ve Uygulama Hastanesi-Fiziksel Tıp ve Rehabilitasyon | Recruiting | Kepez/Çanakkale Merkez/Çanakkale | 17110 | Turkey (Türkiye) |
| İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi-Fiziksel Tıp ve Rehabilitasyon | Recruiting | Merkez/Battalgazi/Malatya | 44280 | Turkey (Türkiye) |
| Karadeniz Teknik Üniversitesi Farabi Hastanesi- Fiziksel Tıp ve Rehabilitasyon | Recruiting | Trabzon Merkez/Ortahisar/Trabzon | 61080 | Turkey (Türkiye) |
| Adana Şehir Eğitim ve Araştırma Hastanesi-Fizik Tedavi ve Rehabilitasyon | Recruiting | Yuregir/Adana | 01060 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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