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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523283-21-00 | EU Trial (CTIS) Number | ||
| J2A-MC-GZPR | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate the effect and safety of orforglipron once daily in participants with Fontaine II peripheral arterial disease (PAD). Participation in the study will last about 58 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orforglipron | Experimental | Participants will receive orforglipron orally |
|
| Placebo | Placebo Comparator | Participants will receive placebo orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orforglipron | Drug | Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Maximum Walking Distance | On a constant load treadmill test | Baseline, Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Pain Free Walking Distance | On a constant load treadmill test | Baseline, Week 52 |
| Change from Baseline in Vascular Quality of Life (VascuQoL-6) Questionnaire Score |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| St. Vincent's Birmingham Hospital | Recruiting | Birmingham | Alabama | 35205 | United States |
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| Label | URL |
|---|---|
| Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease (ATTAIN-PAD) | 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 orally |
|
| Baseline, Week 52 |
| Change from Baseline in 6 Minute Walk Test Distance (meters) | Baseline, Week 52 |
| Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) | Baseline, Week 52 |
| Change from Baseline in Systolic Blood Pressure (mmHg) | Baseline, Week 52 |
| Mercy Gilbert Medical Center | Recruiting | Gilbert | Arizona | 85297 | United States |
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| Emvera Health at Peak Heart & Vascular Surprise | Recruiting | Surprise | Arizona | 85378 | United States |
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| Del Sol Research Management, LLC | Recruiting | Tucson | Arizona | 85715 | United States |
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| Valley Clinical Trials, LLC dba Flourish Research | Recruiting | Northridge | California | 91325 | United States |
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| The Cardiovascular Center | Recruiting | Redding | California | 96001 | United States |
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| InvivoCure | Recruiting | Van Nuys | California | 91405 | United States |
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| Interventional Cardiology Medical Group | Recruiting | West Hills | California | 91307 | United States |
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| Lakeview Institute of Clinical Research | Recruiting | Leesburg | Florida | 34748 | United States |
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| Inpatient Research Clinic | Recruiting | Miami Lakes | Florida | 33014 | United States |
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| Floridian Clinical Research, LLC | Recruiting | Miami Lakes | Florida | 33016-1518 | United States |
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| St Johns Center for Clinical Research | Recruiting | Saint Augustine | Florida | 32086 | United States |
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| ASHA Clinical Research - Munster, LLC | Recruiting | Hammond | Indiana | 46324 | United States |
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| Indiana University Health Methodist Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| Deaconess Clinic- Gateway | Recruiting | Newburgh | Indiana | 47630 | United States |
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| Flourish Research - Bowie | Recruiting | Bowie | Maryland | 20715 | United States |
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| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Recruiting | Troy | Michigan | 48098 | United States |
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| Capital Area Research, LLC | Recruiting | Camp Hill | Pennsylvania | 17011 | United States |
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| The Jackson Clinic | Recruiting | Jackson | Tennessee | 38305 | United States |
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| East Coast Institute for Research - Jefferson City | Recruiting | Jefferson City | Tennessee | 37760 | United States |
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| Biopharma Informatic, LLC | Recruiting | Houston | Texas | 77084 | United States |
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| Research Physicians Network, LLC | Recruiting | Houston | Texas | 77089 | United States |
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| Sherman Clinical Research | Recruiting | Sherman | Texas | 75090 | United States |
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| NextStage Clinical Research - Waco | Recruiting | Waco | Texas | 76712 | United States |
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| Alpine Research Organization | Recruiting | Clinton | Utah | 84015 | United States |
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| Stroobants Cardiovascular Center | Recruiting | Lynchburg | Virginia | 24501 | United States |
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| Clinical Research Partners, LLC | Recruiting | Richmond | Virginia | 23226 | United States |
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| Gershon Pain Specialists | Recruiting | Virginia Beach | Virginia | 23454 | United States |
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| ERA Health Research - CardioNow - Lynnwood | Recruiting | Lynnwood | Washington | 98036 | United States |
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| Eastside Research Associates | Recruiting | Redmond | Washington | 98052 | United States |
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| CIPREC | Not yet recruiting | Buenos Aires | 1061 | Argentina |
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| CIPREC | Recruiting | Buenos Aires | C1119ACN | Argentina |
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| Sanatorio Finochietto | Recruiting | Buenos Aires | C1187AAN | Argentina |
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| CEMEDIC | Recruiting | Buenos Aires | C1407GTN | Argentina |
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| Instituto de Investigaciones Clínicas Córdoba | Recruiting | Córdoba | 5000 | Argentina |
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| MICA - Medicina e Investigación Cardiometabólica | Not yet recruiting | Del Viso | 1669 | Argentina |
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| Centro de Investigaciones Clínicas Baigorria | Not yet recruiting | Granadero Baigorria | 2152 | Argentina |
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| DIM Clínica Privada | Recruiting | Ramos Mejía | B1704ETD | Argentina |
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| Fundacion Estudios Clinicos | Not yet recruiting | Rosario | 2000 | Argentina |
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| INECO Neurociencias Oroño | Recruiting | Rosario | 2000 | Argentina |
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| Instituto de Investigaciones Clinicas Rosario | Recruiting | Rosario | S2000CVD | Argentina |
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| Go Centro Medico San Nicolás | Recruiting | San Nicolás | 2900 | Argentina |
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| Centro de Salud e Investigaciones Médicas | Recruiting | Santa Rosa | L6300 | Argentina |
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| Box Hill Hospital | Recruiting | Box Hill | 3128 | Australia |
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| Core Research Group | Recruiting | Brisbane | 4064 | Australia |
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| Canberra Hospital | Recruiting | Canberra | 2605 | Australia |
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| University of the Sunshine Coast (UniSC) Clinical Trials - Meadowbrook | Recruiting | Meadowbrook | 4131 | Australia |
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| Royal Perth Hospital | Recruiting | Perth | 6000 | Australia |
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| Gold Coast University Hospital | Recruiting | Southport | 4215 | Australia |
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| Centro de Pesquisa Clinica do Coracao | Recruiting | Aracaju | 49055-530 | Brazil |
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| Hospital Universitário João de Barros Barreto | Not yet recruiting | Belém | 66073-000 | Brazil |
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| Instituto de Pesquisa clinica de Campinas | Recruiting | Campinas | 13060-080 | Brazil |
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| Centro de Pesquisa Sao Lucas | Recruiting | Campinas | 13060-803 | Brazil |
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| Universidade Federal de Goias | Recruiting | Goiânia | 74605-020 | Brazil |
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| Hospital de Clinicas de Porto Alegre | Not yet recruiting | Porto Alegre | 90035-903 | Brazil |
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| Centro Avançado De Pesquisa, Estudos E Diagnóstico (CAPED) - Centro Médico RibeirãoShopping | Recruiting | Ribeirão Preto | 14026-020 | Brazil |
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| Instituto de Molestias Cardiovasculares de Tatui | Recruiting | Tatuí | 18270-170 | Brazil |
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| THEO Medical Concorde | Recruiting | Laval | H7G 2E6 | Canada |
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| Alpha Recherche Clinique - Lévis | Recruiting | Lévis | G6V 0C9 | Canada |
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| KMH Cardiology Centres - Stoney Creek | Recruiting | Stoney Creek | L8J 3W2 | Canada |
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| Corcare | Recruiting | Toronto | M1B 5N1 | Canada |
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| Unity Health Toronto, St. Michael's Hospital | Not yet recruiting | Toronto | M5B 1W8 | Canada |
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| Toronto General Hospital | Not yet recruiting | Toronto | M5G 2C4 | Canada |
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| Cardio 1 Medical Clinic | Recruiting | Winnipeg | R3L 1Z5 | Canada |
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| Xuanwu Hospital Capital Medical University | Recruiting | Beijing | 100053 | China |
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| Peking University Third Hospital | Recruiting | Beijing | 100091 | China |
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| Beijing Pinggu District Hospital | Recruiting | Beijing | 101200 | China |
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| Sichuan Provincial People's Hospital | Recruiting | Chengdu | 610072 | China |
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| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | 510000 | China |
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| The Fourth Affiliated Hospital of Harbin Medical University | Not yet recruiting | Harbin | 150001 | China |
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| Heilongjiang Provincial Hospital | Recruiting | Harbin | 150036 | China |
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| The First Affiliated Hospital of Henan University of Science &Technology | Recruiting | Luoyang Shi | 471003 | China |
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| Nanjing First Hospital | Recruiting | Nanjing | 210006 | China |
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| Nanjing First Hospital | Recruiting | Nanjing | 210012 | China |
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| Jiangsu Province Hospital | Recruiting | Nanjing | 210029 | China |
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| Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | 200023 | China |
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| Zhongshan Hospital,Fudan University | Recruiting | Shanghai | 200032 | China |
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| Tianjin Medical University General Hospital | Recruiting | Tianjin | 300052 | China |
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| Tianjin People' s Hospital | Recruiting | Tianjin | 300121 | China |
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| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | 325000 | China |
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| Wuhan University Medical College - Hubei Zhongshan Hospital | Not yet recruiting | Wuhan | 430000 | China |
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| The First Affiliated Hospital of Xi'an Medical University | Recruiting | Xi'an | 710077 | China |
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| Centre Hospitalier Universitaire d'Angers | Recruiting | Angers | 49933 | France |
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| CHRU Troussau | Recruiting | Chambray-lès-Tours | 37170 | France |
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| Hôpital Saint Philibert | Recruiting | Lomme | 59160 | France |
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| Centre Hospitalier Universitaire de Nice - Hopital Pasteur | Recruiting | Nice | 06000 | France |
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| Groupe hospitalier Paris saint Joseph | Recruiting | Paris | 75014 | France |
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| Hôpital Européen Georges Pompidou | Recruiting | Paris | 75015 | France |
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| Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou | Recruiting | Rennes | 35033 | France |
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| Jawaharlal Nehru Medical College | Not yet recruiting | Aligarh | 202002 | India |
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| Priyanka Hospital & Cardiac Center | Not yet recruiting | Jaipur | 302020 | India |
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| M. P. Birla Group - Belle Vue Clinic | Recruiting | Kolkata | 700017 | India |
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| Government Medical College - Kozhikode | Not yet recruiting | Kozhikode | 673008 | India |
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| Central India Cardiology and Research Institute | Not yet recruiting | Nagpur | 440015 | India |
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| Lata Mangeshkar Hospital - Digdoh | Recruiting | Nagpur | 440019 | India |
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| All India Institute of Medical Sciences (AIIMS) - Nagpur | Not yet recruiting | Nagpur | 441108 | India |
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| Vijan Hospital & Research Centre | Recruiting | Nashik | 422005 | India |
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| Sir Ganga Ram Hospital | Not yet recruiting | New Delhi | 110060 | India |
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| All India Institute of Medical Sciences - Rishikesh | Recruiting | Rishikesh | 249203 | India |
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| Nirmal Hospital Pvt Ltd. | Not yet recruiting | Surat | 395002 | India |
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| University of Yamanashi Hospital | Recruiting | Chūō | 409-3898 | Japan |
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| Fukuyama City Hospital | Recruiting | Fukuyama | 721-8511 | Japan |
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| Hakodate Municipal Hospital | Recruiting | Hakodate | 041-8680 | Japan |
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| Medical Corporation Sapporo Heart Center Sapporo Cardio Vascular Clinic | Recruiting | Higashi | 007-0849 | Japan |
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| Mito Medical Center | Not yet recruiting | Higashiibaraki | 311-3117 | Japan |
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| National Hospital Organization Kanazawa Medical Center | Recruiting | Kanazawa | 920-8650 | Japan |
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| Shinyurigaoka General Hospital | Recruiting | Kawasaki | 215-0026 | Japan |
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| Kokura Memorial Hospital | Recruiting | Kitakyushu | 802-8555 | Japan |
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| Kobe City Medical Center General Hospital | Recruiting | Kobe | 650-0047 | Japan |
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| Omi Medical Center | Not yet recruiting | Kusatsu | 525-0066 | Japan |
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| Seikeikai Medical Corporation New Tokyo Heart Clinic | Recruiting | Matsudo | 271-0077 | Japan |
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| Tokyo Saiseikai Central Hospital | Not yet recruiting | Minatoku | 108-0073 | Japan |
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| Japanese Red Cross Musashino Hospital | Recruiting | Musashino-shi | 180-8610 | Japan |
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| Koujunkai Daido Clinic | Recruiting | Nagoya | 457-8511 | Japan |
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| Nakakinen clinic | Recruiting | Naka | 311-0113 | Japan |
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| National Hospital Organization Osaka National Hospital | Recruiting | Osaka | 540-0006 | Japan |
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| Osaka Keisatsu Hospital | Recruiting | Osaka | 543-0042 | Japan |
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| Kansai Electric Power Hospital | Recruiting | Osaka | 553-0003 | Japan |
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| Osaka General Medical Center | Recruiting | Osaka | 558-8558 | Japan |
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| Oita Oka Hospital | Not yet recruiting | Ōita | 870-0192 | Japan |
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| Saitama City Hospital | Recruiting | Saitama | 336-8522 | Japan |
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| Japan Community Healthcare Organization Hokkaido Hospital | Recruiting | Sapporo | 062-8618 | Japan |
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| Iwate Medical University Hospital | Recruiting | Shiwa-gun Yahaba-cho | 028-3695 | Japan |
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| Municipal Toyonaka Hospital | Recruiting | Toyonaka | 560-0055 | Japan |
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| Yamagata University Hospital | Recruiting | Yamagata | 990-9585 | Japan |
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| Yokohama City Minato Red Cross Hospital | Recruiting | Yokohama | 231-0801 | Japan |
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| Albert Schweitzer Ziekenhuis, locatie Dordwijk | Not yet recruiting | Dordrecht | 3318 AT | Netherlands |
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| Catharina Ziekenhuis | Not yet recruiting | Eindhoven | 5623 EJ | Netherlands |
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| Radboudumc | Not yet recruiting | Nijmegen | 6525 GA | Netherlands |
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| Centrum Medyczne INTERCOR Sp. z o.o. | Recruiting | Bydgoszcz | 85-605 | Poland |
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| NZOZ Twoje Zdrowie EL Sp. z o. o. | Recruiting | Elblag | 82-300 | Poland |
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| Przychodnie Grudziądz | Recruiting | Grudziądz | 86-300 | Poland |
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| Centrum Medyczne Komorniki | Recruiting | Komorniki | 62-052 | Poland |
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| Poliklinika Kardiologiczna Serce | Recruiting | Leszno | 64-100 | Poland |
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| Research and Cardiovascular Corp. | Recruiting | Ponce | 00717 | Puerto Rico |
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| Alian - Bardejov | Not yet recruiting | Bardejov | 085 01 | Slovakia |
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| MEDIVASA | Recruiting | Žilina | 01001 | Slovakia |
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| Daegu Catholic University Medical Center | Recruiting | Daegu | 42472 | South Korea |
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| Korea University Anam Hospital | Recruiting | Seoul | 02841 | South Korea |
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| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
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| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
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| Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting | Kaohsiung City | 807 | Taiwan |
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| Chang Gung Memorial Hospital at Kaohsiung | Recruiting | Kaohsiung Niao Sung Dist | 83301 | Taiwan |
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| National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
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| Chang Gung Medical Foundation-Linkou Branch | Recruiting | Taoyuan | 333 | Taiwan |
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| Imperial College Healthcare NHS Trust, Charing Cross Hospital | Recruiting | London | W6 8RF | United Kingdom |
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| Derriford Hospital | Recruiting | Plymouth | Pl6 8DH | United Kingdom |
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| Royal Stoke University Hospital | Not yet recruiting | Stoke-on-Trent | ST4 6QG | United Kingdom |
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| Swansea University | Not yet recruiting | Swansea | SA2 8PP | United Kingdom |
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| Moorgreen Hospital | Recruiting | West End | SO30 3JB | United Kingdom |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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| ID | Term |
|---|---|
| C000729680 | orforglipron |
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