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| ID | Type | Description | Link |
|---|---|---|---|
| J3R-MC-YDAL | Other Identifier | Eli Lilly and Company | |
| 2025-523659-73-00 | EU Trial (CTIS) Number |
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The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo in participants with persistent obesity or overweight, with or without type 2 diabetes, and on stable incretin background therapy.
Participation in the study will last about 80 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eloralintide Dose 1 | Experimental | Participants will receive eloralintide subcutaneously (SC) |
|
| Eloralintide Dose 2 | Experimental | Participants will receive eloralintide SC |
|
| Eloralintide Dose 3 | Experimental | Participants will receive eloralintide SC |
|
| Eloralintide Dose 4 | Experimental | Participants will receive eloralintide SC |
|
| Placebo | 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 | Baseline, Week 64 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Waist Circumference | Baseline, Week 64 | |
| Percent Change in Baseline in Triglycerides | Baseline, Week 64 | |
| Change from Baseline in Systolic Blood Pressure |
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Inclusion Criteria:
Are on stable incretin therapy at screening
With persistent obesity or overweight defined as:
≥30 kg/m2 OR
≥27 kg/m2 with at least one existing obesity related complication at screening:
Have a stable body weight (<5% body weight change) at screening
Exclusion Criteria:
Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed >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
Have taken any of the following antihyperglycemic medications within 90 days before screening:
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
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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 |
|---|---|---|---|---|---|---|
| Birmingham Clinical Research | Recruiting | Birmingham | Alabama | 35209 | United States |
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| Label | URL |
|---|---|
| A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly Incretin (ENLIGHTEN-6) | 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 | Administered SC |
|
| Baseline, Week 64 |
| Change from Baseline in Body Mass Index (BMI) | Baseline, Week 64 |
| Change from Baseline in Fasting Glucose in Participants with Type 2 Diabetes at Baseline | Baseline, Week 64 |
| Change from Baseline in Short Form-36 (SF-36 v2) Score | Baseline, Week 64 |
| Change from Baseline in EQ-5D-5L Score | Baseline, Week 64 |
| Change from Baseline in Control of Eating Questionnaire (CoEQ) Score | Baseline, Week 64 |
| Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) Physical Function Weight | Baseline, Week 64 |
| Percent Change from Baseline in Fasting Insulin | Baseline, Week 64 |
| Percent Change from Baseline in High Sensitivity C-Reactive Protein (hsCRP) | Baseline, Week 64 |
| Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) | Baseline, Week 64 |
| Change in Medication Use | Baseline through Week 64 |
| Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax,ss) | Baseline through Week 64 |
| PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-ᴛ)ss) | Baseline through Week 64 |
| RIO Clinical Trials - Phoenix | Recruiting | Phoenix | Arizona | 85016 | United States |
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| Headlands Research - Scottsdale | Recruiting | Scottsdale | Arizona | 85260 | United States |
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| Novak Clinical Research - Tucson - North La Cholla Boulevard | Recruiting | Tucson | Arizona | 85741 | United States |
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| Irvine Clinical Research | Recruiting | Irvine | California | 92614 | United States |
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| Scripps Whittier Diabetes Institute | Recruiting | La Jolla | California | 92037 | United States |
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| EndoTrials Center for Clinical Research | Not yet recruiting | La Mesa | California | 91942 | United States |
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| Peninsula Research Associates | Recruiting | Rolling Hills Estates | California | 90274 | United States |
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| Care Access - Sacramento | Recruiting | Sacramento | California | 95831 | United States |
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| Artemis Institute for Clinical Research | Recruiting | San Diego | California | 92123 | United States |
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| Southern California Clinical Research | Recruiting | Santa Ana | California | 92701 | United States |
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| University Clinical Investigators, Inc. | Recruiting | Tustin | California | 92780 | United States |
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| New England Research Associates, LLC | Recruiting | Bridgeport | Connecticut | 06606 | United States |
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| Yale University School of Medicine | Recruiting | New Haven | Connecticut | 06519 | United States |
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| Chase Medical Research, LLC | Recruiting | Waterbury | Connecticut | 06708 | United States |
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| JEM Research Institute | Recruiting | Atlantis | Florida | 33462 | United States |
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| AMR Clinical | Recruiting | Doral | Florida | 33172 | United States |
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| Northeast Research Institute (NERI) | Recruiting | Fleming Island | Florida | 32003 | United States |
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| Jacksonville Center for Clinical Research | Recruiting | Jacksonville | Florida | 32216 | United States |
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| New Horizon Research Center | Recruiting | Miami | Florida | 33165 | United States |
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| St Johns Center for Clinical Research | Recruiting | Saint Augustine | Florida | 32086 | United States |
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| Metabolic Research Institute, Inc. | Recruiting | West Palm Beach | Florida | 33401 | United States |
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| Teak Research Consults - Dunwoody | Recruiting | Dunwoody | Georgia | 30338 | United States |
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| Center for Advanced Research & Education | Recruiting | Gainesville | Georgia | 30501 | United States |
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| Clinical Research Atlanta | Not yet recruiting | Stockbridge | Georgia | 30281 | United States |
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| Family First Medical Center | Recruiting | Idaho Falls | Idaho | 83404 | United States |
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| Great Lakes Clinical Trials - Ravenswood | Recruiting | Chicago | Illinois | 60640 | United States |
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| Iowa Diabetes and Endocrinology Research Center | Recruiting | West Des Moines | Iowa | 50266 | United States |
|
| Cotton O'Neil Diabetes & Endocrinology | Recruiting | Topeka | Kansas | 66606 | United States |
|
| AMR Clinical | Recruiting | Lexington | Kentucky | 40509 | United States |
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| IMA Clinical Research Monroe - Armand | Recruiting | Monroe | Louisiana | 71201 | United States |
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| Centennial Medical Group | Recruiting | Columbia | Maryland | 21045 | United States |
|
| Brigham and Women's Hospital Diabetes Program | Recruiting | Boston | Massachusetts | 02115 | United States |
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| MedVadis Research Corporation | Not yet recruiting | Waltham | Massachusetts | 02451 | United States |
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| Great Lakes Research Institute | Recruiting | Southfield | Michigan | 48075 | United States |
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| Revive Research Institute, Inc. | Not yet recruiting | Southfield | Michigan | 48075 | United States |
|
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Recruiting | Troy | Michigan | 48098 | United States |
|
| Clinical Research Professionals | Recruiting | Chesterfield | Missouri | 63005 | United States |
|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
|
| Weill Cornell Medical College | Recruiting | New York | New York | 10021 | United States |
|
| IMA Clinical Research Manhattan | Recruiting | New York | New York | 10036 | United States |
|
| University of North Carolina Medical Center | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
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| Medication Management | Recruiting | Greensboro | North Carolina | 27405 | United States |
|
| Carteret Medical Group | Recruiting | Morehead City | North Carolina | 28557 | United States |
|
| Accellacare - Wilmington - 1917 Tradd Court | Recruiting | Wilmington | North Carolina | 28401 | United States |
|
| CTI Clinical Research Center | Not yet recruiting | Cincinnati | Ohio | 45212 | United States |
|
| Care Access - Lima | Recruiting | Lima | Ohio | 45805 | United States |
|
| Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18) | Recruiting | Pittsburgh | Pennsylvania | 15236 | United States |
|
| Trial Management Associates | Not yet recruiting | Myrtle Beach | South Carolina | 29572 | United States |
|
| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| Juno Research | Recruiting | Houston | Texas | 77040 | United States |
|
| Activian Clinical Research | Not yet recruiting | Kingwood | Texas | 77339 | United States |
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| Texas Valley Clinical Research (TVCR) - Mission | Not yet recruiting | Mission | Texas | 78572 | United States |
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| Synergy Groups Medical LLC - Missouri City | Recruiting | Missouri City | Texas | 77459 | United States |
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| IMA Clinical Research San Antonio | Recruiting | San Antonio | Texas | 78229 | 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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| Medrasa Clinical Research | Recruiting | Wylie | Texas | 75098 | United States |
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| Emeritus Research | Recruiting | Botany | 2019 | Australia |
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| Box Hill Hospital | Recruiting | Box Hill | 3128 | Australia |
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| Royal Brisbane and Women's Hospital | Recruiting | Brisbane | 4029 | Australia |
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| Emeritus Research | Recruiting | Camberwell | 3124 | Australia |
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| Barwon Health | Recruiting | Geelong | 3220 | Australia |
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| Austin Health - Repatriation Hospital | Recruiting | Heidelberg West | 3081 | Australia |
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| AIM Research | Recruiting | Merewether | 2291 | Australia |
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| Southern Adelaide Diabetes & Endocrine Services | Recruiting | Oaklands Park | 5046 | Australia |
|
| Royal North Shore Hospital | Recruiting | St Leonards | 2065 | Australia |
|
| Innovate Clinical Research | Recruiting | Waitara | 2077 | Australia |
|
| Imelda General Hospital | Recruiting | Bonheiden | 2820 | Belgium |
|
| Université Libre de Bruxelles - Hôpital Erasme | Not yet recruiting | Brussels | 1070 | Belgium |
|
| Ziekenhuis Oost-Limburg, Campus St.-Jan | Not yet recruiting | Genk | 3600 | Belgium |
|
| Jan Yperman Ziekenhuis | Recruiting | Ieper | 8900 | Belgium |
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| AZ Groeninge Campus Kennedylaan | Recruiting | Kortrijk | 8500 | Belgium |
|
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
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| AZ Sint-Maarten | Not yet recruiting | Mechelen | 2800 | Belgium |
|
| Meclinas | Recruiting | Mechelen | 2800 | Belgium |
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| Az Damiaan vzw | Not yet recruiting | Ostend | 8400 | Belgium |
|
| Quanta Diagnóstico e Terapia | Not yet recruiting | Curitiba | 80045170 | Brazil |
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| Centro de Diabetes Curitiba | Not yet recruiting | Curitiba | 80810-040 | Brazil |
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| Private Practice - Dr.Miguel N. Hissa | Not yet recruiting | Fortaleza | 60430-350 | Brazil |
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| CPCLIN | Not yet recruiting | São Paulo | 01228-200 | Brazil |
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| Hospital 9 De Julho | Not yet recruiting | São Paulo | 01409-901 | Brazil |
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| CEDOES | Not yet recruiting | Vitória | 29055450 | Brazil |
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| Integral Pesquisa e Ensino | Not yet recruiting | Votuporanga | 15500-269 | Brazil |
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| Luhe Hospital | Not yet recruiting | Beijing | 100000 | China |
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| The First Hospital of Jilin University | 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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| The Second Xiangya Hospital of Central South University | Not yet recruiting | Changsha | 410011 | China |
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| Sichuan Provincial People's Hospital | Not yet recruiting | Chengdu | 610072 | China |
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| West China Hospital Sichuan University | Not yet recruiting | Chengdu | 610041 | China |
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| 2nd Affiliated Hospital Chongqing Medical Universi | Not yet recruiting | Chongqing | 400000 | China |
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| Zhujiang Hospital | Not yet recruiting | Guangzhou | 510280 | China |
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| The Affiliated Hospital of Guizhou Medical University | Not yet recruiting | Guiyang | 550004 | China |
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| The Second People's Hospital of Hefei | Not yet recruiting | Hefei | 230011 | China |
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| Huzhou Central Hospital | Not yet recruiting | Huzhou | 313000 | China |
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| The First Affiliated Hospital of Henan University of Science &Technology | Not yet recruiting | Luoyang Shi | 471023 | China |
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| Affiliated Hospital of Luzhou Medical College | Not yet recruiting | Luzhou | 646000 | China |
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| Jiangxi Provincial People's Hospital | Not yet recruiting | Nanchang | 330038 | 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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| Ningbo First Hospital | Not yet recruiting | Ningbo | 315010 | China |
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| Zhongshan Hospital,Fudan University | Not yet recruiting | Shanghai | 200032 | China |
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| ResTrial s.r.o. | Recruiting | Prague | 18100 | Czechia |
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| Nizam's Institute of Medical Sciences | Not yet recruiting | Hyderabad | 500082 | India |
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| Eternal Heart Care Center and Research Institute | Not yet recruiting | Jaipur | 302020 | India |
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| Atmaram Child Care | Not yet recruiting | Kanpur | 208011 | India |
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| Shree Mahalaxmi DIATONE Institute | Not yet recruiting | Kolhāpur | 416001 | India |
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| BSES MG Hospital | Not yet recruiting | Mumbai | 400058 | India |
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| Mysore Medical College | Not yet recruiting | Mysore | 570001 | India |
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| All India Institute of Medical Sciences (AIIMS) - Nagpur | Not yet recruiting | Nagpur | 441108 | India |
|
| Supe Heart & Diabetes Hospital and Research Centre | Not yet recruiting | Nashik | 422002 | India |
|
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|
| Emek Medical Center | Not yet recruiting | Afula | 1834111 | Israel |
|
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|
| Soroka Medical Center | Not yet recruiting | Beersheba | 8410101 | Israel |
|
| Hillel Yaffe Medical Center | Not yet recruiting | Hadera | 3810101 | Israel |
|
| Rambam Health Care Campus | Not yet recruiting | Haifa | 3109601 | Israel |
|
| Edith Wolfson Medical Center | Not yet recruiting | Holon | 5810001 | Israel |
|
| Hadassah Medical Center | Not yet recruiting | Jerusalem | 9112001 | Israel |
|
| Meir Medical Center | Not yet recruiting | Kfar Saba | 4428164 | Israel |
|
| Maccabi health care services - Qiryat Motzkin | Not yet recruiting | Kiryat Motzkin | 2642435 | Israel |
|
| Laniado Hospital | Not yet recruiting | Netanya | 4244914 | Israel |
|
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|
| Rabin Medical Center | Not yet recruiting | Petah Tikva | 4941492 | Israel |
|
| Sheba Medical Center | Not yet recruiting | Ramat Gan | 5262100 | Israel |
|
| Kaplan Medical Center | Not yet recruiting | Rehovot | 7610001 | Israel |
|
| Clalit Health Services - Sakhnin Community Clinic | Not yet recruiting | Sakhnin | 3081000 | Israel |
|
| Diabetes Medical Center | Not yet recruiting | Tel Aviv | 51549 | Israel |
|
| Sourasky Medical Center | Not yet recruiting | Tel Aviv | 6423906 | Israel |
|
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|
| Rinku General Medical Center | Recruiting | Izumisano | 598-8577 | Japan |
|
| Kanto Rosai Hospital | Recruiting | Kawasaki | 211-8510 | Japan |
|
| Kimitsu Chuo Hospital | Recruiting | Kisarazu | 292-8535 | Japan |
|
| Kure Medical Center | Recruiting | Kure | 737-0023 | Japan |
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| Takeda General Hospital - Kyoto | Recruiting | Kyoto | 601-1495 | Japan |
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| Mikannohana Clinic, Diabetes, Endocrinology and Metabolism | Recruiting | Matsuyama | 7900034 | Japan |
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| Kansai Electric Power Hospital | Recruiting | Osaka | 553-0003 | Japan |
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| Manda Memorial Hospital | Recruiting | Sapporo | 060-0062 | Japan |
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| Shimonoseki Medical Center | Recruiting | Shimonoseki | 750-0061 | Japan |
|
| Japanese Red Cross Society - Wakayama Medical Center | Recruiting | Wakayama | 640-8558 | Japan |
|
| Medical Center Metas | Not yet recruiting | Chihuahua City | 31110 | Mexico |
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| Private Practice - Dr. Arechavaleta Granell Maria del Rosario | Not yet recruiting | Guadalajara | 44670 | Mexico |
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| Invecordis S.C. | Not yet recruiting | Huixquilucan | 52763 | Mexico |
|
| Centro de Investigacion en Artritis y Osteoporosis SC | Not yet recruiting | Mexicali | 21200 | Mexico |
|
| CEINV Salud | Not yet recruiting | Monterrey | 64020 | Mexico |
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| Clínica García Flores SC | Not yet recruiting | Monterrey | 64610 | Mexico |
|
| Advanced Clinical Research, LLC | Recruiting | Bayamón | 00959 | Puerto Rico |
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| Isis Clinical Research Center | Recruiting | Guaynabo | 00968 | Puerto Rico |
|
| Mariodiab Clinic | Recruiting | Brasov | 500097 | Romania |
|
| C.M.D.T.A. Neomed | Recruiting | Brasov | 500283 | Romania |
|
| Geea Medical Easy Diet | Recruiting | Bucharest | 010627 | Romania |
|
| Centrul Medical NutriLife | Not yet recruiting | Bucharest | 013764 | Romania |
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| Gama Diamed | Not yet recruiting | Mangalia | 905500 | Romania |
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| Diabdana | Not yet recruiting | Oradea | 410147 | Romania |
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| Clinica Korall | Not yet recruiting | Satu Mare | 440055 | Romania |
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| Rinart Diab SRL | Not yet recruiting | Targoviste | 130168 | Romania |
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| SC Dentosim Queen SRL - Centrul Medical Diamed | Not yet recruiting | Târgu Mureş | 540098 | Romania |
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| Cabinet Medical Dr.Geru | Not yet recruiting | Timișoara | 300288 | Romania |
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| Hospital San Rafael - La Coruña | Recruiting | A Coruña | 15006 | Spain |
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| Centro Periférico de Especialidades Bola Azul | Recruiting | Almería | 04009 | Spain |
|
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
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| Instituto Gallego de Cirugía Ocular | Recruiting | Ferrol | 15402 | Spain |
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| Clínica Juaneda | Recruiting | Palma de Mallorca | 07014 | Spain |
|
| Hospital Universitario Quironsalud Madrid | Recruiting | Pozuelo de Alarcón | 28223 | Spain |
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| Hospital Universitario Marqués de Valdecilla | Recruiting | Santander | 39008 | Spain |
|
| Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE) | Recruiting | Seville | 41003 | Spain |
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| Hospital Quiron Infanta Luisa | Recruiting | Seville | 41010 | Spain |
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| Vithas Hospital Sevilla | Recruiting | Seville | 41950 | Spain |
|
| Chiayi Christian Hospital | Not yet recruiting | Chiayi City | 600 | Taiwan |
|
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting | Kaohsiung City | 807 | Taiwan |
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| Chang Gung Memorial Hospital at Kaohsiung | Not yet recruiting | Kaohsiung Niao Sung Dist | 83301 | Taiwan |
|
| China Medical University Hospital | Recruiting | Taichung | 404332 | Taiwan |
|
| National Cheng Kung University Hospital | Recruiting | Tainan | 704 | Taiwan |
|
| National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
|
| Taipei Medical University Hospital | Not yet recruiting | Taipei | 110 | Taiwan |
|
| Taipei Veterans General Hospital | Recruiting | Taipei | 11217 | Taiwan |
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| Chang Gung Medical Foundation-Linkou Branch | Recruiting | Taoyuan | 333 | Taiwan |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| 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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