Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

Last updated: May 13, 2026
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Peripheral Arterial Occlusive Disease

Claudication

Treatment

Orforglipron

Placebo

Clinical Study ID

NCT07223593
27632
J2A-MC-GZPR
2025-523283-21-00
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have symptomatic PAD with intermittent claudication of Fontaine Stage II

  • Have an Ankle Brachial Index (ABI) of 0.9 or less

Exclusion

Exclusion Criteria:

  • Have a body mass index (BMI) less than 23 kilogram per square meter (kg/m2)

  • Have Hemoglobin A1c (HbA1c) greater than 10%

  • Have walking ability limited by conditions other than PAD

  • Have a planned lower limb surgery or any other surgery affecting walking ability

  • Had peripheral revascularization procedure within 90 days prior to the day ofscreening or planning to undergo peripheral revascularization during the clinicaltrial

  • Had stroke, transient ischemic attack, myocardial infarction, coronary or carotidrevascularization, or hospitalization for unstable angina pectoris within 60 daysprior to screening

  • Have heart failure presently classified as being in New York Heart Association classIII - IV

Study Design

Total Participants: 1205
Treatment Group(s): 2
Primary Treatment: Orforglipron
Phase: 3
Study Start date:
October 31, 2025
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • CEMEDIC

    Buenos Aires, C1407GTN
    Argentina

    Site Not Available

  • CIPREC

    Buenos Aires, C1119ACN
    Argentina

    Active - Recruiting

  • Sanatorio Finochietto

    Buenos Aires, C1187AAN
    Argentina

    Active - Recruiting

  • CEMEDIC

    Buenos Aires 3435910, C1407GTN
    Argentina

    Site Not Available

  • CIPREC

    Buenos Aires 3435910, C1119ACN
    Argentina

    Site Not Available

  • Sanatorio Finochietto

    Buenos Aires 3435910, C1187AAN
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clínicas Córdoba

    Córdoba, 5000
    Argentina

    Active - Recruiting

  • Instituto de Investigaciones Clínicas Córdoba

    Córdoba 3860259, 5000
    Argentina

    Site Not Available

  • DIM Clínica Privada

    Ramos Mejía, B1704ETD
    Argentina

    Active - Recruiting

  • DIM Clínica Privada

    Ramos Mejía 3429617, B1704ETD
    Argentina

    Site Not Available

  • INECO Neurociencias Oroño

    Rosario, 2000
    Argentina

    Active - Recruiting

  • Instituto de Investigaciones Clinicas Rosario

    Rosario, S2000CVD
    Argentina

    Active - Recruiting

  • INECO Neurociencias Oroño

    Rosario 3838583, 2000
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clinicas Rosario

    Rosario 3838583, S2000CVD
    Argentina

    Site Not Available

  • Go Centro Medico San Nicolás

    San Nicolás, 2900
    Argentina

    Active - Recruiting

  • Go Centro Medico San Nicolás

    San Nicolás 3832624, 2900
    Argentina

    Site Not Available

  • Centro de Salud e Investigaciones Médicas

    Santa Rosa, L6300
    Argentina

    Active - Recruiting

  • Centro de Salud e Investigaciones Médicas

    Santa Rosa 3835994, L6300
    Argentina

    Site Not Available

  • Box Hill Hospital

    Box Hill, 3128
    Australia

    Active - Recruiting

  • Box Hill Hospital

    Box Hill 2174360, 3128
    Australia

    Site Not Available

  • Core Research Group

    Brisbane, 4064
    Australia

    Active - Recruiting

  • Core Research Group

    Brisbane 2174003, 4064
    Australia

    Site Not Available

  • Canberra Hospital

    Canberra, 2605
    Australia

    Active - Recruiting

  • Canberra Hospital

    Canberra 2172517, 2605
    Australia

    Site Not Available

  • University of the Sunshine Coast (UniSC) Clinical Trials - Meadowbrook

    Meadowbrook, 4131
    Australia

    Active - Recruiting

  • University of the Sunshine Coast (UniSC) Clinical Trials - Meadowbrook

    Meadowbrook 8348893, 4131
    Australia

    Site Not Available

  • Royal Perth Hospital

    Perth, 6000
    Australia

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  • Royal Perth Hospital

    Perth 2063523, 6000
    Australia

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  • Gold Coast University Hospital

    Southport, 4215
    Australia

    Site Not Available

  • Gold Coast University Hospital

    Southport 2148928, 4215
    Australia

    Site Not Available

  • Centro de Pesquisa Clinica do Coracao

    Aracaju, 49055-530
    Brazil

    Site Not Available

  • Centro de Pesquisa Clinica do Coracao

    Aracaju 3471872, 49055-530
    Brazil

    Site Not Available

  • Hospital Universitário João de Barros Barreto

    Belém, 66073-000
    Brazil

    Site Not Available

  • Hospital Universitário João de Barros Barreto

    Belém 3405870, 66073-000
    Brazil

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  • Centro de Pesquisa Sao Lucas

    Campinas, 13060-803
    Brazil

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    Campinas, 13060-080
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  • Centro de Pesquisa Sao Lucas

    Campinas 3467865, 13060-803
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  • Universidade Federal de Goias

    Goiânia, 74605-020
    Brazil

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  • Universidade Federal de Goias

    Goiânia 3462377, 74605-020
    Brazil

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  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, 90035-903
    Brazil

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  • Hospital de Clinicas de Porto Alegre

    Porto Alegre 3452925, 90035-903
    Brazil

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  • Centro Avançado De Pesquisa, Estudos E Diagnóstico (CAPED) - Centro Médico RibeirãoShopping

    Ribeirão Preto, 14026-020
    Brazil

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    Tatuí, 18270-170
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    Laval, H7G 2E6
    Canada

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    Canada

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    Canada

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    Lévis 6325521, G6V 0C9
    Canada

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    Beijing, 101200
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    Beijing, 100091
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    Beijing, 100053
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    Harbin, 150036
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    Harbin 2037013, 150036
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    Luoyang Shi, 471003
    China

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    Nanjing, 210029
    China

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    Nanjing, 210012
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    Nanjing 1799962, 210029
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    Nanjing 1799962, 210006
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  • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, 200023
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    Shanghai, 200032
    China

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    Shanghai 1796236, 200023
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    Shanghai 1796236, 200032
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  • Tianjin Medical University General Hospital

    Tianjin, 300052
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  • Tianjin People' s Hospital

    Tianjin, 300121
    China

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  • Tianjin Medical University General Hospital

    Tianjin 1792947, 300052
    China

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  • Tianjin People' s Hospital

    Tianjin 1792947, 300121
    China

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  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000
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  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou 1791388, 325000
    China

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  • The First Affiliated Hospital of Xi'an Medical University

    Xi'an, 710077
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  • The First Affiliated Hospital of Xi'an Medical University

    Xi'an 1790630, 710077
    China

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  • Centre Hospitalier Universitaire d'Angers

    Angers, 49933
    France

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  • Centre Hospitalier Universitaire d'Angers

    Angers 3037656, 49933
    France

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  • CHRU Troussau

    Chambray-lès-Tours, 37170
    France

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  • CHRU Troussau

    Chambray-lès-Tours 3027343, 37170
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  • Hôpital Saint Philibert

    Lomme, 59160
    France

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  • Hôpital Saint Philibert

    Lomme 2997803, 59160
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nice - Hopital Pasteur

    Nice, 06000
    France

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  • Centre Hospitalier Universitaire de Nice - Hopital Pasteur

    Nice 2990440, 06000
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  • Groupe hospitalier Paris saint Joseph

    Paris, 75014
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  • Hôpital Européen Georges Pompidou

    Paris, 75015
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  • Groupe hospitalier Paris saint Joseph

    Paris 2988507, 75014
    France

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  • Hôpital Européen Georges Pompidou

    Paris 2988507, 75015
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  • Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou

    Rennes, 35033
    France

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  • Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou

    Rennes 2983990, 35033
    France

    Site Not Available

  • Jawaharlal Nehru Medical College

    Aligarh, 202002
    India

    Site Not Available

  • Jawaharlal Nehru Medical College

    Aligarh 1279017, 202002
    India

    Site Not Available

  • M. P. Birla Group - Belle Vue Clinic

    Kolkata, 700017
    India

    Site Not Available

  • M. P. Birla Group - Belle Vue Clinic

    Kolkata 1275004, 700017
    India

    Site Not Available

  • Government Medical College - Kozhikode

    Kozhikode, 673008
    India

    Site Not Available

  • Government Medical College - Kozhikode

    Kozhikode 1265873, 673008
    India

    Site Not Available

  • All India Institute of Medical Sciences (AIIMS) - Nagpur

    Nagpur, 441108
    India

    Site Not Available

  • Lata Mangeshkar Hospital - Digdoh

    Nagpur, 440019
    India

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  • All India Institute of Medical Sciences (AIIMS) - Nagpur

    Nagpur 1262180, 441108
    India

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  • Lata Mangeshkar Hospital - Digdoh

    Nagpur 1262180, 440019
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  • Vijan Hospital & Research Centre

    Nashik, 422005
    India

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  • Vijan Hospital & Research Centre

    Nashik 1261731, 422005
    India

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  • Sir Ganga Ram Hospital

    New Delhi, 110060
    India

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  • Sir Ganga Ram Hospital

    New Delhi 1261481, 110060
    India

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  • All India Institute of Medical Sciences - Rishikesh

    Rishikesh, 249203
    India

    Site Not Available

  • All India Institute of Medical Sciences - Rishikesh

    Rishikesh 1258128, 249203
    India

    Site Not Available

  • University of Yamanashi Hospital

    Chūō, 409-3898
    Japan

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  • University of Yamanashi Hospital

    Chūō 13353695, 409-3898
    Japan

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  • Fukuyama City Hospital

    Fukuyama, 721-8511
    Japan

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  • Fukuyama City Hospital

    Fukuyama 1863917, 721-8511
    Japan

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  • Hakodate Municipal Hospital

    Hakodate, 041-8680
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  • Hakodate Municipal Hospital

    Hakodate 2130188, 041-8680
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  • Medical Corporation Sapporo Heart Center Sapporo Cardio Vascular Clinic

    Higashi, 007-0849
    Japan

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  • Medical Corporation Sapporo Heart Center Sapporo Cardio Vascular Clinic

    Higashi 1862855, 007-0849
    Japan

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  • National Hospital Organization Kanazawa Medical Center

    Kanazawa, 920-8650
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  • National Hospital Organization Kanazawa Medical Center

    Kanazawa 1860243, 920-8650
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  • Shinyurigaoka General Hospital

    Kawasaki, 215-0026
    Japan

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  • Shinyurigaoka General Hospital

    Kawasaki 1859642, 215-0026
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  • Kokura Memorial Hospital

    Kitakyushu, 802-8555
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  • Kokura Memorial Hospital

    Kitakyushu 1859307, 802-8555
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  • Kobe City Medical Center General Hospital

    Kobe, 650-0047
    Japan

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  • Kobe City Medical Center General Hospital

    Kobe 1859171, 650-0047
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  • Seikeikai Medical Corporation New Tokyo Heart Clinic

    Matsudo, 271-0077
    Japan

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  • Seikeikai Medical Corporation New Tokyo Heart Clinic

    Matsudo 1857553, 271-0077
    Japan

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  • Tokyo Saiseikai Central Hospital

    Minatoku, 108-0073
    Japan

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  • Tokyo Saiseikai Central Hospital

    Minatoku 11191118, 108-0073
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  • Japanese Red Cross Musashino Hospital

    Musashino-shi, 180-8610
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  • Koujunkai Daido Clinic

    Nagoya, 457-8511
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  • Koujunkai Daido Clinic

    Nagoya 1856057, 457-8511
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  • Nakakinen clinic

    Naka, 311-0113
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  • Nakakinen clinic

    Naka 2111749, 311-0113
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    Osaka, 553-0003
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  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006
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    Osaka, 558-8558
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    Osaka, 543-0042
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  • Kansai Electric Power Hospital

    Osaka 1853909, 553-0003
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    Osaka 1853909, 540-0006
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    Osaka 1853909, 558-8558
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    Osaka 1853909, 543-0042
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  • Saitama City Hospital

    Saitama, 336-8522
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    Saitama 6940394, 336-8522
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  • Japan Community Healthcare Organization Hokkaido Hospital

    Sapporo, 062-8618
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  • Japan Community Healthcare Organization Hokkaido Hospital

    Sapporo 2128295, 062-8618
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  • Iwate Medical University Hospital

    Shiwa-gun Yahaba-cho, 028-3695
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    Toyonaka, 560-0055
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    Toyonaka 1849837, 560-0055
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    Yamagata, 990-9585
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    Yamagata 2110556, 990-9585
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    Yokohama, 231-0801
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    Yokohama 1848354, 231-0801
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  • Albert Schweitzer Ziekenhuis, locatie Dordwijk

    Dordrecht, 3318 AT
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    Dordrecht 2756669, 3318 AT
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    Bydgoszcz, 85-605
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    Leeds 2644688, LS1 3EX
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    London, W6 8RF
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    Swansea 2636432, SA2 8PP
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    West End, SO30 3JB
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    West End 12048199, SO30 3JB
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    Birmingham, Alabama 35205
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    Gilbert, Arizona 85297
    United States

    Site Not Available

  • Axsendo Clinical Research - Peak Heart & Vascular - Surprise

    Surprise, Arizona 85378
    United States

    Active - Recruiting

  • Del Sol Research Management, LLC

    Tucson, Arizona 85715
    United States

    Active - Recruiting

  • Mercy Gilbert Medical Center

    Gilbert 5295903, Arizona 5551752 85297
    United States

    Site Not Available

  • Axsendo Clinical Research - Peak Heart & Vascular - Surprise

    Surprise 5316428, Arizona 5551752 85378
    United States

    Site Not Available

  • Del Sol Research Management, LLC

    Tucson 5318313, Arizona 5551752 85715
    United States

    Site Not Available

  • Valley Clinical Trials, Inc.

    Northridge, California 91325
    United States

    Active - Recruiting

  • The Cardiovascular Center

    Redding, California 96001
    United States

    Active - Recruiting

  • InvivoCure

    Van Nuys, California 91405
    United States

    Site Not Available

  • Interventional Cardiology Medical Group

    West Hills, California 91307
    United States

    Active - Recruiting

  • Valley Clinical Trials, Inc.

    Northridge 5377985, California 5332921 91325
    United States

    Site Not Available

  • The Cardiovascular Center

    Redding 5570160, California 5332921 96001
    United States

    Site Not Available

  • InvivoCure

    Van Nuys 5405693, California 5332921 91405
    United States

    Site Not Available

  • Interventional Cardiology Medical Group

    West Hills 8030162, California 5332921 91307
    United States

    Site Not Available

  • Lakeview Institute of Clinical Research

    Leesburg, Florida 34748
    United States

    Active - Recruiting

  • Floridian Clinical Research, LLC

    Miami Lakes, Florida 33016-1518
    United States

    Active - Recruiting

  • Inpatient Research Clinic

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • St Johns Center for Clinical Research

    Saint Augustine, Florida 32086
    United States

    Active - Recruiting

  • Lakeview Institute of Clinical Research

    Leesburg 4161771, Florida 4155751 34748
    United States

    Site Not Available

  • Floridian Clinical Research, LLC

    Miami Lakes 4164186, Florida 4155751 33016-1518
    United States

    Site Not Available

  • Inpatient Research Clinic

    Miami Lakes 4164186, Florida 4155751 33014
    United States

    Active - Recruiting

  • Advanced Research for Health Improvement, LLC

    Naples 4165565, Florida 4155751 34102
    United States

    Site Not Available

  • St Johns Center for Clinical Research

    Saint Augustine 4170894, Florida 4155751 32086
    United States

    Site Not Available

  • ASHA Clinical Research - Munster, LLC

    Hammond, Indiana 46324
    United States

    Active - Recruiting

  • Indiana University Health Methodist Hospital

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Deaconess Clinic- Gateway

    Newburgh, Indiana 47630
    United States

    Active - Recruiting

  • ASHA Clinical Research - Munster, LLC

    Hammond 4921100, Indiana 4921868 46324
    United States

    Site Not Available

  • Indiana University Health Methodist Hospital

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Site Not Available

  • Deaconess Clinic- Gateway

    Newburgh 4262171, Indiana 4921868 47630
    United States

    Site Not Available

  • Flourish Research - Bowie

    Bowie, Maryland 20715
    United States

    Active - Recruiting

  • Flourish Research - Bowie

    Bowie 4349159, Maryland 4361885 20715
    United States

    Site Not Available

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan 48098
    United States

    Active - Recruiting

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy 5012639, Michigan 5001836 48098
    United States

    Site Not Available

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania 17011
    United States

    Active - Recruiting

  • Capital Area Research, LLC

    Camp Hill 5182928, Pennsylvania 6254927 17011
    United States

    Site Not Available

  • The Jackson Clinic

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • East Coast Institute for Research - Jefferson City

    Jefferson City, Tennessee 37760
    United States

    Active - Recruiting

  • The Jackson Clinic

    Jackson 4632595, Tennessee 4662168 38305
    United States

    Site Not Available

  • East Coast Institute for Research - Jefferson City

    Jefferson City 4632959, Tennessee 4662168 37760
    United States

    Site Not Available

  • Biopharma Informatic, LLC

    Houston, Texas 77084
    United States

    Active - Recruiting

  • Research Physicians Network, LLC

    Houston, Texas 77089
    United States

    Active - Recruiting

  • Sherman Clinical Research

    Sherman, Texas 75090
    United States

    Active - Recruiting

  • NextStage Clinical Research - Waco

    Waco, Texas 76712
    United States

    Active - Recruiting

  • Biopharma Informatic, LLC

    Houston 4699066, Texas 4736286 77084
    United States

    Site Not Available

  • Research Physicians Network, LLC

    Houston 4699066, Texas 4736286 77089
    United States

    Active - Recruiting

  • Sherman Clinical Research

    Sherman 4728328, Texas 4736286 75090
    United States

    Site Not Available

  • NextStage Clinical Research - Waco

    Waco 4739526, Texas 4736286 76712
    United States

    Site Not Available

  • Alpine Research Organization

    Clinton, Utah 84015
    United States

    Active - Recruiting

  • Alpine Research Organization

    Clinton 5773001, Utah 5549030 84015
    United States

    Site Not Available

  • Stroobants Cardiovascular Center

    Lynchburg, Virginia 24501
    United States

    Active - Recruiting

  • Clinical Research Partners, LLC

    Richmond, Virginia 23226
    United States

    Active - Recruiting

  • Gershon Pain Specialists

    Virginia Beach, Virginia 23454
    United States

    Active - Recruiting

  • Stroobants Cardiovascular Center

    Lynchburg 4771075, Virginia 6254928 24501
    United States

    Site Not Available

  • Clinical Research Partners, LLC

    Richmond 4781708, Virginia 6254928 23226
    United States

    Site Not Available

  • Gershon Pain Specialists

    Virginia Beach 4791259, Virginia 6254928 23454
    United States

    Site Not Available

  • ERA Health Research - CardioNow - Lynnwood

    Lynnwood, Washington 98036
    United States

    Active - Recruiting

  • Eastside Research Associates

    Redmond, Washington 98052
    United States

    Active - Recruiting

  • ERA Health Research - CardioNow - Lynnwood

    Lynnwood 5802049, Washington 5815135 98036
    United States

    Site Not Available

  • Eastside Research Associates

    Redmond 5808079, Washington 5815135 98052
    United States

    Site Not Available

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