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| ID | Type | Description | Link |
|---|---|---|---|
| J3R-MC-YDAG | Other Identifier | Eli Lilly and Company | |
| 2025-523657-34-00 | Other Identifier | EU CTIS |
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The purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase.
Participation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.
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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 |
|---|---|---|
| Percent Change from Baseline in Total Body Fat Mass | Baseline, Week 64 | |
| Change from Baseline in Waist Circumference | Baseline, Week 64 | |
| Percent Change from Baseline in Triglycerides |
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Inclusion Criteria:
Have Body Mass Index (BMI) at screening of the following:
30 kilogram per square meter (kg/m2) OR
27 kg/m2 with at least one of the following weight-related health conditions at screening:
Have a stable body weight (<5% body weight change) for 90 days prior to screening.
Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight
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 or type 2 diabetes
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 question or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | 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 |
|---|---|---|---|---|---|---|
| MFA Clinical Research | Recruiting | Tuscaloosa | Alabama | 35405 | United States |
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 should be approved by an independent review panel and researchers should sign a data sharing agreement.
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| Placebo | Drug | Administered SC |
|
| Baseline, Week 64 |
| Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 64 |
| Time to Onset of Type 2 Diabetes (T2D) | Time to Onset of Type 2 Diabetes (T2D) in Participants with Prediabetes at Randomization | Baseline to Week 168 and Week 191 |
| Change from Baseline in Body Mass Index (BMI) | Baseline, Week 64 |
| Change from Baseline in Hemoglobin A1c (HbA1c) | 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 from Baseline in Short Form-36 Version 2 (SF-36 v2) Score | Baseline, Week 64 |
| Change from Baseline in EQ-5D-5L | Baseline, Week 64 |
| Change from Baseline in Control of Eating Questionnaire (CoEQ) Score | Baseline, Week 64 |
| Achievement of Improved Categorical Shift in Patient Global Improvement of Status (PGIS) Physical Function Weight | Baseline, Week 64 |
| Change in Medication Use | Baseline through Week 64 |
| Percent Change from Baseline in Body Weight in Participants with Prediabetes at Randomization | Baseline, Week 168 |
| 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 |
| Headlands Research - Scottsdale | Recruiting | Scottsdale | Arizona | 85260 | United States |
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| Neighborhood Healthcare Institute of Health | Recruiting | Escondido | California | 92025 | United States |
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| Ark Clinical Research - Fountain Valley | Recruiting | Fountain Valley | California | 92708 | United States |
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| Desert Oasis Healthcare Medical Group | Recruiting | Palm Springs | California | 92262 | United States |
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| Peninsula Research Associates | Recruiting | Rolling Hills Estates | California | 90274 | United States |
|
| Care Access - Sacramento | Recruiting | Sacramento | California | 95831 | United States |
|
| 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 |
|
| 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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| BioMed Research & Medical Center | Recruiting | Miami | Florida | 33156 | United States |
|
| Adult Medicine of Lake County, Inc. | Recruiting | Mt. Dora | Florida | 32757 | United States |
|
| American Research Centers of Florida | Recruiting | Pembroke Pines | Florida | 33027 | United States |
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| AHF Pensacola | Recruiting | Pensacola | Florida | 32503 | United States |
|
| IMA Clinical Research St. Petersburg | Recruiting | St. Petersburg | Florida | 33704 | United States |
|
| Teak Research Consults - Dunwoody | Recruiting | Dunwoody | Georgia | 30338 | United States |
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| Teak Research Consults | Recruiting | Lawrenceville | Georgia | 30043 | United States |
|
| Clinical Research Atlanta | Recruiting | Stockbridge | Georgia | 30281 | United States |
|
| East-West Medical Research Institute | Recruiting | Honolulu | Hawaii | 96814 | United States |
|
| Iowa Diabetes and Endocrinology Research Center | Recruiting | West Des Moines | Iowa | 50266 | United States |
|
| Cotton O'Neil Clinical Research Center | Recruiting | Topeka | Kansas | 66606 | United States |
|
| Care Access - Lake Charles (Bayou Pines) | Recruiting | Lake Charles | Louisiana | 70601 | United States |
|
| MedStar Good Samaritan Hospital | Recruiting | Baltimore | Maryland | 21239 | United States |
|
| MedStar Health Research Institute (MedStar Physician Based Research Network) | Recruiting | Hyattsville | Maryland | 20782 | United States |
|
| Care Access - Quincy | Recruiting | Quincy | Massachusetts | 02169 | United States |
|
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Recruiting | Troy | Michigan | 48098 | United States |
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| AMR Clinical | Recruiting | Las Vegas | Nevada | 89119 | United States |
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| IMA Clinical Research Warren | Recruiting | Warren Township | New Jersey | 07059 | United States |
|
| Albuquerque Clinical Trials, Inc. | Recruiting | Albuquerque | New Mexico | 87102 | United States |
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| Rochester Clinical Research, LLC | Recruiting | Rochester | New York | 14609 | United States |
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| Monroe Biomedical Research | Recruiting | Monroe | North Carolina | 28112 | United States |
|
| Preferred Primary Care Physicians | Recruiting | Uniontown | Pennsylvania | 15401 | United States |
|
| Tribe Clinical Research, LLC | Recruiting | Greenville | South Carolina | 29607 | United States |
|
| Accellacare - Mt Pleasant | Recruiting | Mt. Pleasant | South Carolina | 29464 | United States |
|
| AMR Clinical | Recruiting | Nashville | Tennessee | 37203 | United States |
|
| The University of Texas Health Science Center at Houston | Recruiting | Bellaire | Texas | 77401 | United States |
|
| Velocity Clinical Research, Dallas | Recruiting | Dallas | Texas | 75230 | United States |
|
| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390-9302 | United States |
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| IMA Clinical Research San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
|
| AMR Clinical | Recruiting | Norfolk | Virginia | 23502 | United States |
|
| CONEXA Investigacion Clinica S.A. | Not yet recruiting | Buenos Aires | 1012 | Argentina |
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| CIPREC | Not yet recruiting | Buenos Aires | 1061 | Argentina |
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| Cicemo Srl | Not yet recruiting | Buenos Aires | 1424 | Argentina |
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| Cardiología Palermo | Not yet recruiting | Buenos Aires | 1425 | Argentina |
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| Glenny Corp. S.A. | Not yet recruiting | Buenos Aires | 1430 | Argentina |
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| CARDIAMET Investigaciones Médicas | Not yet recruiting | Buenos Aires | C1014ACP | Argentina |
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| Centro Médico Viamonte | Not yet recruiting | Buenos Aires | C1120AAC | Argentina |
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| Fundación Respirar | Not yet recruiting | Buenos Aires | C1426ABP | Argentina |
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| Instituto de Investigaciones Clínicas Córdoba | Not yet recruiting | Córdoba | 5000 | Argentina |
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| CIPADI - Centro Integral de Prevencion y Atencion en Diabetes | Not yet recruiting | Godoy Cruz | M5501ARP | 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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| Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica | Not yet recruiting | Rosario | 2000 | Argentina |
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| Laboratorio de Hemostasia y Trombosis | Not yet recruiting | Rosario | S2000DTB | Argentina |
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| Centro de Investigaciones Médicas Tucuman | Not yet recruiting | SAN M. de Tucuman | T4000AXL | Argentina |
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| Centro Modelo de Cardiología | Not yet recruiting | San Miguel de Tucumán | 4000 | Argentina |
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| Centro de Salud e Investigaciones Médicas | Not yet recruiting | Santa Rosa | L6300 | Argentina |
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| Emeritus Research | Not yet recruiting | Botany | 2019 | Australia |
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| Core Research Group | Not yet recruiting | Brisbane | 4064 | Australia |
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| Emeritus Research | Recruiting | Camberwell | 3124 | Australia |
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| Life Clinical Research | Not yet recruiting | Ipswich | 4305 | Australia |
|
| Paratus Clinical Research Central Coast | Recruiting | Kanwal | 2259 | Australia |
|
| University of the Sunshine Coast (UniSC) Clinical Trials - Meadowbrook | Not yet recruiting | Meadowbrook | 4131 | Australia |
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| Momentum Sunshine | Recruiting | Melbourne | 3021 | Australia |
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| Paratus Clinical Research - Melbourne | Not yet recruiting | Melbourne | 3070 | Australia |
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| AIM Research | Not yet recruiting | Merewether | 2291 | Australia |
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| Fusion Clinical Research | Recruiting | Norwood | 5067 | Australia |
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| USC Clinical Trials Sunshine Coast | Not yet recruiting | Sippy Downs | 4556 | Australia |
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| ANIMA Research | Recruiting | Diepenbeek | 3590 | Belgium |
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| Jessa Ziekenhuis | Recruiting | Hasselt | 3500 | Belgium |
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| Kormont | Recruiting | Kluisbergen | 9690 | Belgium |
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| Gezondheidshuis De Gloed | Recruiting | Machelen | 9870 | Belgium |
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| Chronos Pesquisa Clínica | Not yet recruiting | Brasília | 72145-450 | Brazil |
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| Instituto de Pesquisa clinica de Campinas | Not yet recruiting | Campinas | 13060-080 | Brazil |
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| Private Practice - Dr.Miguel N. Hissa | Not yet recruiting | Fortaleza | 60430-350 | Brazil |
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| Centro de Pesquisa Clínica de Marília - CPCLIM | Not yet recruiting | Marília | 17504-072 | Brazil |
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| Núcleo de Pesquisa Clínica do Rio Grande do Sul | Not yet recruiting | Porto Alegre | 90430-001 | Brazil |
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| IBPClin - Instituto Brasil de Pesquisa Clínica | Not yet recruiting | Rio de Janeiro | 20241-180 | Brazil |
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| Ruschel Medicina e Pesquisa Clínica | Not yet recruiting | Rio de Janeiro | 22270-060 | Brazil |
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| CPCLIN | Not yet recruiting | São Paulo | 01228-200 | Brazil |
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| CEPIC - Centro Paulista de Investigação Clínica | Not yet recruiting | São Paulo | 04266-010 | 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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| Aggarwal and Associates Limited | Recruiting | Brampton | L6T 0G1 | Canada |
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| Med Trust Research | Recruiting | Courtice | L1E 2J5 | Canada |
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| Dawson Clinical Research Inc. | Recruiting | Guelph | N1H 1B1 | Canada |
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| Winterberry Research Inc. | Recruiting | Hamilton | L8J 0B6 | Canada |
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| The Wharton Medical Clinic Clinical Trials Inc | Recruiting | Hamilton | L8L 5G8 | Canada |
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| Alpha Recherche Clinique | Recruiting | Québec | G2J 0C4 | Canada |
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| ALPHA Recherche Clinique | Recruiting | Québec | G3K 2P8 | Canada |
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| Bluewater Clinical Research Group Inc. | Recruiting | Sarnia | N7T 4X3 | Canada |
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| Diex Recherche Inc. Division Trois-Rivieres | Recruiting | Trois-Rivières | G9A 4P3 | Canada |
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| Luhe Hospital | Not yet recruiting | Beijing | 1001199 | China |
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| Beijing Pinggu District Hospital | Not yet recruiting | Beijing | 101200 | 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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| Zhujiang Hospital | Not yet recruiting | Guangzhou | 510280 | 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 Shi | 471003 | China |
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| Jiangxi Provincial People's Hospital | Not yet recruiting | Nanchang | 330006 | China |
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| Nanjing First Hospital | Not yet recruiting | Nanjing | 210006 | China |
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| Jiangsu Province Official Hospital | Not yet recruiting | Nanjing | 210008 | 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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| Shanghai Sixth People's Hospital | Not yet recruiting | Shanghai | China |
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| Zentrum fur klinische Forschung - Köln | Active, not recruiting | Cologne | 51069 | Germany |
| Universitaetsklinikum Carl Gustav Carus Dresden | Active, not recruiting | Dresden | 01307 | Germany |
| StudyPoint Duisburg | Active, not recruiting | Duisburg | 47269 | Germany |
| InnoDiab Forschung Gmbh | Active, not recruiting | Essen | 45136 | Germany |
| Medizentrum Essen Borbeck | Active, not recruiting | Essen | 45355 | Germany |
| Diabetes Zentrum Wilhelmsburg | Active, not recruiting | Hamburg | 21109 | Germany |
| Diabeteszentrum Hamburg West | Recruiting | Hamburg | 22607 | Germany |
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| AmBeNet GmbH | Recruiting | Leipzig | 04107 | Germany |
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| Diabetologische Schwerpunktpraxis Dr. Staudenmeyer & Dr. Schiwietz | Active, not recruiting | Lingen | 49808 | Germany |
| BAG Drs. Med. Quist PartG | Recruiting | Mainz | 55128 | Germany |
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| CRS Clinical Research Services Mannheim | Recruiting | Mannheim | 68167 | Germany |
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| RED-Institut GmbH | Active, not recruiting | Oldenburg | 23758 | Germany |
| Praxis Sauter & Sauter & Vorbach | Active, not recruiting | Wangen | 88239 | Germany |
| Endolife Speciality Hospitals | Not yet recruiting | Guntur | 522001 | India |
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| Gauhati Medical College and Hospital | Not yet recruiting | Guwahati | 781032 | India |
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| Care Hospitals Hyderabad- Banjara Hills | Not yet recruiting | Hyderabad | 500034 | India |
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| Mandya Institute Of Medical Sciences | Not yet recruiting | Mandya | 571401 | India |
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| Topiwala National Medical College & B. Y. L. Nair Charitable Hospital | Not yet recruiting | Mumbai | 400008 | 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 |
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| Supe Heart & Diabetes Hospital and Research Centre | Not yet recruiting | Nashik | 422002 | India |
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| Lifepoint Multispeciality Hospital | Not yet recruiting | Pune | 411057 | India |
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| Prabhu Diabetes Multi-Speciality Centre | Not yet recruiting | Trichy | 620001 | India |
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| Adachi Kyosai Hospital | Recruiting | Adachi-ku | 120-0022 | Japan |
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| Nihonbashi Sakura Clinic | Recruiting | Chūōku | 103-0025 | Japan |
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| Medical Corporation Chiseikai Tokyo Center Clinic | Recruiting | Chūōku | 103-0027 | Japan |
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| Tokyo-Eki Center-building Clinic | Recruiting | Chūōku | 103-0027 | Japan |
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| Boocs Clinic Fukuoka | Recruiting | Fukuoka | 812-0025 | Japan |
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| Patient First Clinic Ginza-Shimbashi | Recruiting | Minato | 105-0004 | Japan |
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| Kanno Naika | Recruiting | Mitaka | 181-0013 | Japan |
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| Medical Corporation Heishinkai OCROM Clinic | Recruiting | Suita-shi | 565-0853 | Japan |
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| Higashi Shinjuku Clinic | Recruiting | Tokyo | 169-0072 | Japan |
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| Zdrowie Osteo-Medic | Recruiting | Bialystok | 15-351 | Poland |
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| Legeartis - Poradnie Specjalistyczne | Recruiting | Bialystok | 15-404 | Poland |
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| Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET | Recruiting | Krakow | 31-261 | Poland |
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| Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna | Recruiting | Lodz | 90-338 | Poland |
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| Gabinety TERPA | Recruiting | Lublin | 20-333 | Poland |
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| Ekamed | Recruiting | Lublin | 20-718 | Poland |
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| Centrum Zdrowia Metabolicznego Pawel Bogdanski | Recruiting | Poznan | 60-589 | Poland |
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| Pracownia Badań Klinicznych Salus | Recruiting | Wroclaw | 53-034 | Poland |
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| Samodzielny Publiczny Szpital Kliniczny nr 1 SUM | Recruiting | Zabrze | 41-800 | Poland |
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| Puerto Rico Health and Wellness Institute | Recruiting | Dorado | 00646 | Puerto Rico |
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| Wellness clinical Research Vega Baja | Recruiting | Vega Baja | 00693 | Puerto Rico |
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| Gachon University Gil Medical Center | Recruiting | Namdong-gu | 21565 | South Korea |
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| Konyang University Hospital | Recruiting | Seogu | 35365 | South Korea |
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| Seoul National University Bundang Hospital | Recruiting | Seongnam | 13620 | South Korea |
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| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
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| Pusan National University Yangsan Hospital | Recruiting | Yangsan | 50612 | South Korea |
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| Chiayi Christian Hospital | Not yet recruiting | Chiayi City | 600 | Taiwan |
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| Kaohsiung Medical University Chung-Ho Memorial Hospital | Not yet recruiting | Kaohsiung City | 807 | Taiwan |
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| Chang Gung Memorial Hospital at Kaohsiung | Not yet recruiting | Kaohsiung Niao Sung Dist | 83301 | Taiwan |
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| National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
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| Taipei Veterans General Hospital | Recruiting | Taipei | 11217 | Taiwan |
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| Layton Medical Centre | Not yet recruiting | Blackpool | FY3 7EN | United Kingdom |
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| Bradford on Avon Health Centre | Not yet recruiting | Bradford-on-Avon | BA15 1DQ | United Kingdom |
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| Ashton Medical Group - Chapel House | Not yet recruiting | Lancashire | OL6 6EW | United Kingdom |
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| Royal Lancaster Infirmary | Not yet recruiting | Lancaster | LA1 4RP | United Kingdom |
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| Altnagelvin Area Hospital | Not yet recruiting | Londonderry | BT47 6SB | United Kingdom |
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| Bodyline Clinic - Openshaw | Not yet recruiting | Manchester | M11 1AA | United Kingdom |
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| Wansford Research Limited | Not yet recruiting | Peterborough | PE8 6PL | United Kingdom |
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| Abbeywell Surgery | Not yet recruiting | Romsey | SO51 7QN | United Kingdom |
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| Rame Group Practice | Not yet recruiting | Torpoint | PL11 2TB | United Kingdom |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| 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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