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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523768-19-00 | EU Trial (CTIS) Number | ||
| J3R-MC-YDAN | Other Identifier | Eli Lilly and Company | |
| J3R-MC-YOA1 | Other Identifier | Eli Lilly and Company | |
| J3R-MC-YOA2 | Other Identifier | Eli Lilly and Company |
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The YDAN master protocol will support two independent studies, J3R-MC-YOA1 and J3R-MC-YOA2. Each study will investigate how well and safely Eloralintide (LY3841136) works in adults with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Participation in the study will last about 75 weeks, including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eloralintide (YOA1) | Experimental | Participants will receive eloralintide subcutaneously (SC) |
|
| Placebo (YOA1) | Placebo Comparator | Participants will receive placebo SC |
|
| Eloralintide (YOA2) | Experimental | Participants will receive eloralintide SC |
|
| Placebo (YOA2) | Placebo Comparator | Participants will receive placebo SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eloralintide | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight | Percent Change from Baseline in Body Weight | Baseline, Week 64 |
| Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Change from Baseline in the WOMAC Pain Subscale Score | Baseline, Week 64 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Systolic Blood Pressure (SBP) | Change from Baseline in SBP | Baseline, Week 64 |
| Percent Change from Baseline in Triglycerides | Percent Change in Baseline in Triglycerides |
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Inclusion Criteria:
Have a body mass index (BMI) of 27 kilograms per square meter (kg/m²) or higher at screening
Have a stable body weight (less than 5% body weight change) for 90 days prior to screening
Have tried at least once to lose weight through diet but were unsuccessful
Have osteoarthritis of the knee and at least one of the following conditions:
Exclusion Criteria:
Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed greater than 1 year before screening)
Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)
Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
Have an active knee infection
Have had within 90 days prior to screening:
Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure
Have taken medications or alternative remedies intended for weight loss within 90 days of screening
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMR Clinical | Recruiting | Mobile | Alabama | 36608 | United States |
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| Label | URL |
|---|---|
| Lilly Trials | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Placebo | Drug | Placebo administered SC |
|
| Baseline, Week 64 |
| Change from Baseline in Short Form-36 (SF-36 v2) Acute Form Physical Functioning Domain Score | Change from Baseline in SF-36 v2 Score | Baseline, Week 64 |
| Percent Change from Baseline in High Sensitivity, C-reactive Protein (hsCRP) | Percent Change from Baseline in hsCRP | Baseline, Week 64 |
| Change from Baseline in the WOMAC Physical Function Subscale Score | Change from Baseline in the WOMAC Physical Function Subscale Score | Baseline, Week 40, Week 64 |
| Change from Baseline WOMAC Pain Subscale Score | Change from Baseline WOMAC Pain Subscale Score | Baseline, Week 40 |
| Change from Baseline in Distance Walked During the 6-Minute Walk Test | Change from Baseline in Distance Walked During the 6-Minute Walk Test | Baseline, Week 64 |
| Change from Baseline in Body Mass Index (BMI) | Change from Baseline in BMI | Baseline, Week 64 |
| Change in Medication Use | Change in Medication Use | Baseline, Week 64 |
| Change from Baseline in SF-36v2 Acute Form Domain Scores With Exception of the Physical Functioning Domain Score | Change from Baseline in SF-36v2 Acute Form Domain Scores With Exception of the Physical Functioning Domain Score | Baseline, Week 64 |
| Change from Baseline in Health Status EQ-5D-5L Health State Utility | Change from Baseline in Health Status EQ-5D-5L Health State Utility | Baseline, Week 64 |
| Percent Change from Baseline in Fasting Insulin | Percent Change from Baseline in Fasting Insulin | Baseline, Week 64 |
| Percent Change from Baseline in Total Cholesterol | Percent Change from Baseline in Total Cholesterol | Baseline, Week 64 |
| Change from Baseline in Waist Circumference | Change from Baseline in Waist Circumference | Baseline, Week 64 |
| Percent Change from Baseline in Hemoglobin A1c (HbA1c) | Percent Change from Baseline in HbA1c | Baseline, Week 64 |
| Change from Baseline in WOMAC Stiffness Subscale Score | Change from Baseline in WOMAC Stiffness Subscale Score | Baseline, Week 64 |
| Change from Baseline in WOMAC Total Score | Change from Baseline in WOMAC Total Score | Baseline, Week 64 |
| Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Pain | Achievement of Improved Categorical Shift in PGIS - Target Knee Pain | Baseline, Week 64 |
| Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Function | Achievement of Improved Categorical Shift in PGIS - Target Knee Function | Baseline, Week 64 |
| Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score | Change from Baseline in API-NRS Score | Baseline, Week 64 |
| Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score | Change from Baseline in WPI-NRS Score | Baseline, Week 64 |
| Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax, ss) | PK: Cmax, ss | Baseline through Week 64 |
| PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-T)ss) | PK: AUC(0-T)ss | Baseline through Week 64 |
| Number of Participants with Allowed Concomitant Pain Medication | Number of Participants with Allowed Concomitant Pain Medication | Baseline, Week 64 |
| Care Access - 801 South Power Road, Mesa | Recruiting | Mesa | Arizona | 85206 | United States |
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| Elite Pain and Spine Institute - South Crimson Road | Recruiting | Mesa | Arizona | 85209 | United States |
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| Elite Clinical Studies, LLC | Not yet recruiting | Phoenix | Arizona | 85018 | United States |
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| Tucson Orthopaedic Institute - North Wyatt Drive | Recruiting | Tucson | Arizona | 85712 | United States |
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| Ark Clinical Research - Fountain Valley | Recruiting | Fountain Valley | California | 92708 | United States |
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| Wolverine Clinical Trials | Recruiting | Santa Ana | California | 92706 | United States |
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| Encompass Clinical Research | Recruiting | Spring Valley | California | 91978 | United States |
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| Diablo Clinical Research, Inc. | Recruiting | Walnut Creek | California | 94598 | United States |
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| Skylight Health Research - Colorado Springs | Not yet recruiting | Colorado Springs | Colorado | 80917 | United States |
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| Westside Center for Clinical Research | Recruiting | Jacksonville | Florida | 32205 | United States |
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| Care Access - St. Petersburg | Recruiting | St. Petersburg | Florida | 33710 | United States |
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| Conquest Research | Recruiting | Winter Park | Florida | 32789 | United States |
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| Orita Clinical Research | Recruiting | Decatur | Georgia | 30034 | United States |
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| Medical Research Partners | Not yet recruiting | Ammon | Idaho | 83406 | United States |
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| Great Lakes Clinical Trials - Ravenswood | Recruiting | Chicago | Illinois | 60640 | United States |
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| Qualmedica Research, LLC | Recruiting | Evansville | Indiana | 47715 | United States |
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| AMR Clinical | Recruiting | Newton | Kansas | 67114 | United States |
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| Monroe Biomedical Research - Louisville | Recruiting | Louisville | Kentucky | 40213 | United States |
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| Skylight Health Research - Burlington | Recruiting | Burlington | Massachusetts | 01803 | United States |
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| Care Access - Quincy | Recruiting | Quincy | Massachusetts | 02169 | United States |
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| Ellipsis Research Group - Brooklyn - 7th Street | Recruiting | Brooklyn | New York | 11215 | United States |
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| Rochester Clinical Research - Buffalo | Recruiting | Buffalo | New York | 14127 | United States |
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| NYC Research INC | Recruiting | Long Island City | New York | 11106 | United States |
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| Rochester Clinical Research, LLC | Recruiting | Rochester | New York | 14609 | United States |
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| Central States Research | Recruiting | Tulsa | Oklahoma | 74136 | United States |
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| Keystone Clinical Studies | Recruiting | Plymouth Meeting | Pennsylvania | 19462 | United States |
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| JCCT - Juno Bellaire Site | Recruiting | Bellaire | Texas | 77401 | United States |
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| Epic Medical Research - DeSoto | Recruiting | DeSoto | Texas | 75115 | United States |
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| Valley Institute of Research - Fort Worth | Recruiting | Fort Worth | Texas | 76164 | United States |
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| Care Access - Houston | Recruiting | Houston | Texas | 77054 | United States |
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| VIP Trials | Recruiting | San Antonio | Texas | 78230 | United States |
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| Endeavor Clinical Trials | Recruiting | San Antonio | Texas | 78240 | United States |
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| Consano Clinical Research, LLC | Recruiting | Shavano Park | Texas | 78231 | United States |
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| Texas Valley Clinical Research | Recruiting | Weslaco | Texas | 78596 | United States |
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| AMR Clinical | Recruiting | South Jordan | Utah | 84095 | United States |
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| Charlottesville Medical Research | Not yet recruiting | Charlottesville | Virginia | 22911 | United States |
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| Paramount Clinical Research - Data Point Clinical Research | Recruiting | Kirkland | Washington | 98034 | United States |
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| Centro Privado de Medicina Familiar / Mindout Research | Not yet recruiting | Buenos Aires | 1417 | Argentina |
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| CARDIAMET Investigaciones Médicas | Not yet recruiting | Buenos Aires | C1014ACP | Argentina |
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| Organizacion Medica de Investigacion | Not yet recruiting | Buenos Aires | C1015ABO | Argentina |
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| Stat Research S.A. | Not yet recruiting | Buenos Aires | C1023AAB | Argentina |
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| Centro Médico Arsema | Not yet recruiting | Buenos Aires | C1427CCL | Argentina |
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| Centro de Investigaciones Clínicas Baigorria | Not yet recruiting | Granadero Baigorria | 2152 | Argentina |
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| INECO Neurociencias Oroño | Not yet recruiting | Rosario | 2000 | Argentina |
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| Instituto Especialidades de la Salud Rosario | Not yet recruiting | Rosario | 2000 | Argentina |
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| Medicina Reumatológica | Not yet recruiting | San Fernando | 1646 | Argentina |
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| Instituto de Alta Complejidad San Isidro | Not yet recruiting | San Isidro | 1642 | Argentina |
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| Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan | Not yet recruiting | San Juan | 5400 | Argentina |
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| Centro de Investigaciones Médicas Tucuman | Not yet recruiting | SAN M. de Tucuman | T4000AXL | Argentina |
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| Centro de Investigaciones Reumatológicas | Not yet recruiting | San Miguel de Tucumán | 4000 | Argentina |
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| Go Centro Medico San Nicolás | Not yet recruiting | San Nicolás | 2900 | Argentina |
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| Antwerp University Hospital | Not yet recruiting | Edegem | 2650 | Belgium |
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| Reuma Clinic, Locatie Jaarbeurslaan | Recruiting | Genk | 3600 | Belgium |
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| UZ Gent | Recruiting | Ghent | 9000 | Belgium |
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| Kormont | Recruiting | Kluisbergen | 9690 | Belgium |
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| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
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| Meclinas | Recruiting | Mechelen | 2800 | Belgium |
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| ZNA Jan Palfijn | Not yet recruiting | Merksem | 2170 | Belgium |
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| Medisch Centrum Latem (Hip Clinic) - Algemeen Ziekenhuis Maria Middelares Location | Not yet recruiting | Sint-Martens-Latem | 9830 | Belgium |
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| Centro de Pesquisa Sao Lucas | Not yet recruiting | Campinas | 13060-803 | Brazil |
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| IBPClin - Instituto Brasil de Pesquisa Clínica | Not yet recruiting | Rio de Janeiro | 20241-180 | Brazil |
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| CPHosp Medicina, Ensino e Pesquisa (CPQuali) | Not yet recruiting | São Paulo | 01228-000 | Brazil |
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| INTEGRA - Pesquisa Clínica e Infusões | Not yet recruiting | São Paulo | 04039-002 | Brazil |
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| CEPIC - Centro Paulista de Investigação Clínica | Not yet recruiting | São Paulo | 04266-010 | Brazil |
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| Hospital das Clinicas FMUSP | Not yet recruiting | São Paulo | 05403-000 | Brazil |
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| Apex Trials | Recruiting | Guelph | N1G 0B4 | Canada |
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| G.R.M.O. (Groupe de recherche en maladies osseuses) Inc. | Not yet recruiting | Québec | G1V 3M7 | Canada |
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| Diex Recherche Inc. Division Quebec | Recruiting | Québec | G1V 4T3 | Canada |
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| Stouffville Medical Research Institute Inc. | Recruiting | Stouffville | L4A 1H2 | Canada |
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| Maple Leaf Research | Recruiting | Toronto | M5G 1K2 | Canada |
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| Dr. Anil K. Gupta Medicine Professional Corporation | Recruiting | Toronto | M9V 4B4 | Canada |
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| Diex Recherche Inc. Division Victoriaville | Recruiting | Victoriaville | G6P 3Z8 | Canada |
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| Beijing Ji Shui Tan Hospital | Not yet recruiting | Beijing | 100035 | China |
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| The First Afflilated Hospital of Bengbu Medical College | Not yet recruiting | Bengbu | 233004 | China |
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| Jilin Province People's Hospital | Not yet recruiting | Changchun | 130021 | China |
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| The Second Hospital of Jilin University | Not yet recruiting | Changchun | 130041 | China |
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| Xiangya Hospital Central South University | Not yet recruiting | Changsha | 410008 | China |
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| 2nd Affiliated Hospital Chongqing Medical Universi | Not yet recruiting | Chongqing | 400000 | China |
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| The Second Affiliated hospital of Zhejiang University school of medicine | Not yet recruiting | Hangzhou | 310052 | China |
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| The Second People's Hospital of Hefei | Not yet recruiting | Hefei | 230011 | China |
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| Jinan Central Hospital | Not yet recruiting | Jinan | 250013 | China |
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| The First Affiliated Hospital of Henan University of Science &Technology | Not yet recruiting | Luoyang | 471003 | China |
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| Nanjing First Hospital | Not yet recruiting | Nanjing | 210006 | China |
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| Zhongda Hospital Southeast University | Not yet recruiting | Nanjing | 210009 | China |
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| The Second Affiliated Hospital of Nanjing Medical University | Not yet recruiting | Nanjing | 210011 | China |
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| Jiangsu Province Hospital | Not yet recruiting | Nanjing | 210029 | China |
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| The first affiliated hospital of Ningbo university | Not yet recruiting | Ningbo | 315010 | China |
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| Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | 200023 | China |
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| Zhongshan Hospital,Fudan University | Not yet recruiting | Shanghai | 200032 | China |
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| Huashan Hospital, Fudan University | Not yet recruiting | Shanghai | 200040 | China |
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| The Second Affiliated Hospital of Soochow University | Not yet recruiting | Suzhou | 215004 | China |
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| Tianjin Hospital | Not yet recruiting | Tianjin | 300211 | China |
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| The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University | Not yet recruiting | Wenzhou | 315100 | China |
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| Tongji Hospital Tongji Medical,Science & Technology | Not yet recruiting | Wuhan | 430030 | China |
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| Xianyang Hospital of Yan'an University | Not yet recruiting | Xianyang | 712000 | China |
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| Pratia Brno | Recruiting | Brno | 602 00 | Czechia |
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| Revmatologie.s.r.o. | Recruiting | Brno | 63800 | Czechia |
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| INREA s.r.o. | Recruiting | Ostrava | 70300 | Czechia |
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| Pratia Pardubice a.s. | Recruiting | Pardubice | 53002 | Czechia |
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| Medical Plus Research | Recruiting | Uherské Hradiště | 686 01 | Czechia |
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| Sanos Clinic - Nordjylland | Recruiting | Gandrup | 9362 | Denmark |
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| Sanos Clinic | Recruiting | Herlev | 2730 | Denmark |
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| Sanos Clinic - Syddanmark | Recruiting | Vejle | 7100 | Denmark |
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| Siteworks GmbH - Bochum | Recruiting | Bochum | 44787 | Germany |
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| Private Practice - Dr. Kai Könemann & Dr. Henrik Könemann | Recruiting | Bünde | 32257 | Germany |
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| StudyPoint Duisburg | Recruiting | Duisburg | 47269 | Germany |
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| HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T | Recruiting | Hamburg | 20095 | Germany |
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| Siteworks - Karlsruhe | Not yet recruiting | Karlsruhe | 76137 | Germany |
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| AmBeNet GmbH | Recruiting | Leipzig | 04107 | Germany |
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| CDG Studienambulanz Hartard | Not yet recruiting | München | 80809 | Germany |
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| Dedicated Research Site FutureMeds | Recruiting | Offenbach | 63065 | Germany |
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| National Hospital Organization Chiba Medical Center | Recruiting | Chiba | 260-8606 | Japan |
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| Tokyo-Eki Center-building Clinic | Recruiting | Chūōku | 103-0027 | Japan |
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| Tokyo Asbo Clinic | Recruiting | Chūōku | 104-0031 | Japan |
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| Shin Komonji Hospital | Recruiting | Kitakyushu-Shi | 800-0057 | Japan |
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| Goto Orthopedic Surgery Clinic | Recruiting | Miyazaki | 880-0835 | Japan |
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| Komagidai Clinic | Recruiting | Nagareyama | 270-0113 | Japan |
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| Fujigaki Clinic | Recruiting | Ōita | 870-0942 | Japan |
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| Saitama City Hospital | Recruiting | Saitama | 336-8522 | Japan |
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| Ibaraki Seinan Medical Center Hospital | Not yet recruiting | Sashima | 306-0433 | Japan |
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| Ogura Orthopedics Surgery | Recruiting | Sendai | 980-0011 | Japan |
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| Katsura Garden Orthopedics | Recruiting | Sendai | 981-3134 | Japan |
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| Ooimachi Orthopedic Surgery and surgery Clinic | Recruiting | Shinagawa-ku Tokyo | 140-0014 | Japan |
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| Masumoto Orthopedics Clinic | Recruiting | Suginami City | 167-0051 | Japan |
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| National Hospital Organization Toyohashi Medical Center | Recruiting | Toyohashi | 440-8510 | Japan |
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| Yamagata Tokushukai Hospital | Recruiting | Yamagata | 990-0834 | Japan |
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| Investigacion y Biomedicina de Chihuahua | Not yet recruiting | Chihuahua City | 31000 | Mexico |
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| Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C. | Not yet recruiting | Ciudad Madero | 89440 | Mexico |
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| Diseno y Planeacion en Investigacion Medica - Guadalajara - Calle Amado Nervo | Not yet recruiting | Guadalajara | 44600 | Mexico |
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| Unidad de Investigación Clínica y Atención Médica HEPA S.C. | Not yet recruiting | Guadalajara | 44670 | Mexico |
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| RM Pharma Specialists - Unidad Especializada en Datos | Not yet recruiting | Mexico City | 03100 | Mexico |
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| Kohler & Milstein Research S.A. De C.V. | Not yet recruiting | Mérida | 97070 | Mexico |
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| IMED Internal Medicine Clin Trials | Not yet recruiting | Monterrey | 64020 | Mexico |
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| UBAM Unidad Biomedica Avanzada Monterrey | Not yet recruiting | Monterrey | 64460 | Mexico |
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| Centro de investigación y control metabólico | Not yet recruiting | Monterrey | 66465 | Mexico |
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| Dorado Medical Complex | Recruiting | Dorado | 00646 | Puerto Rico |
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| GCM Medical Group, PSC - Hato Rey Site | Recruiting | San Juan | 00917 | Puerto Rico |
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| Keimyung University Dongsan Hospital | Recruiting | Daegu | 42601 | South Korea |
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| Boramae Medical Center | Not yet recruiting | Dongjak-gu | 07061 | South Korea |
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| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
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| Severance Hospital, Yonsei University Health System | Not yet recruiting | Seoul | 03722 | South Korea |
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| Asan Medical Center | Not yet recruiting | Seoul | 05505 | South Korea |
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| The Catholic Univ. of Korea Seoul St. Mary's Hospital | Recruiting | Seoul | 06591 | South Korea |
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| Hallym University Kangnam Sacred Heart Hospital | Recruiting | Seoul | 07441 | South Korea |
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| The Catholic University of Korea, Uijeongbu St. Mary's Hospital | Not yet recruiting | Uijeongbu-si | 11765 | South Korea |
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| Changhua Christian Hospital | Not yet recruiting | Changhua County | 50006 | Taiwan |
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| Chang Gung Memorial Hospital at Kaohsiung | Not yet recruiting | Kaohsiung Niao Sung Dist | 83301 | Taiwan |
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| China Medical University Hospital | Not yet recruiting | Taichung | 404332 | Taiwan |
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| National Cheng Kung University Hospital | Not yet recruiting | Tainan | 704 | Taiwan |
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| National Taiwan University Hospital | Not yet recruiting | Taipei | 10002 | Taiwan |
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| Taipei Medical University Hospital | Not yet recruiting | Taipei | 110 | Taiwan |
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| Tri-Service General Hospital | Not yet recruiting | Taipei | 114 | Taiwan |
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| Velocity Clinical Research, Bristol | Recruiting | Bristol | BS8 2RA | United Kingdom |
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| FutureMeds Glasgow - CPS Research | Not yet recruiting | Glasgow | G20 7BE | United Kingdom |
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| FutureMeds - London | Recruiting | London | NW10 2PB | United Kingdom |
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| Futuremeds-Newcastle | Recruiting | Newcastle | NE6 1SG | United Kingdom |
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| Atlantic Medical | Recruiting | Penzance | TR18 3DX | United Kingdom |
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| Woodstock Bower Surgery | Recruiting | Rotherham | S61 1AH | United Kingdom |
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| Panthera Biopartners - Sheffield | Recruiting | Sheffield | S2 5FX | United Kingdom |
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| Panthera Clinic - York | Not yet recruiting | York | YO24 4LJ | United Kingdom |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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