CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)

Last updated: March 5, 2025
Sponsor: Ionis Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Hypertriglyceridemia

Treatment

Olezarsen

Clinical Study ID

NCT05681351
ISIS 678354-CS15
2022-501999-26-00
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Satisfactory completion of either ISIS 678354-CS5 or ISIS 678354-CS6 (last dose asscheduled at Week 49) with an acceptable safety profile, per Investigator judgment.Satisfactory completion requires that the patient did not terminate early fromtreatment.

  • Participants must be on a stable regimen of lipid-lowering therapy that shouldadhere to standard of care (SOC) per local guidelines.

Exclusion

Key Exclusion Criteria:

  • Have any new condition or worsening of existing condition which in the opinion ofthe Investigator would make the participant unsuitable for enrollment, or couldinterfere with the participant participating in or completing the study, includingneed for treatment with disallowed medications, or need to change the requiredstable regimen as per either ISIS 678354-CS5 or ISIS 678354-CS6 study entrycriteria.

NOTE: Other Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 800
Treatment Group(s): 1
Primary Treatment: Olezarsen
Phase: 3
Study Start date:
December 13, 2022
Estimated Completion Date:
September 30, 2026

Study Description

This is a multi-center, open-label study of up to 800 participants with SHTG who would be rolled over from studies ISIS 678354-CS5 (NCT05079919) or ISIS 678354-CS6 (NCT05552326). Day 1 of this study may be same as the Week 53 visit of either ISIS 678354-CS5 or ISIS 678354-CS6, as applicable. Participants will receive olezarsen during the 53-week treatment period. The study will include a 31-day qualification Period, a 53-week treatment period, and a 13-week post-treatment period.

Connect with a study center

  • CIPREC

    Buenos Aires, C1061
    Argentina

    Active - Recruiting

  • Royal North Shore Hospital

    Saint Leonards, New South Wales 2065
    Australia

    Active - Recruiting

  • Royal Adelaide Hospital

    Adelaide, 5000
    Australia

    Active - Recruiting

  • Royal Prince Alfred Hospital

    Camperdown, 2050
    Australia

    Active - Recruiting

  • Monash Medical Centre

    Clayton, 3168
    Australia

    Active - Recruiting

  • Dr Heart Pty Ltd

    Woolloongabba, 4102
    Australia

    Active - Recruiting

  • MHAT- Blagoevgrad AD

    Blagoevgrad, 2700
    Bulgaria

    Active - Recruiting

  • Medical Center Doctor Staykov EOOD

    Burgas, 8000
    Bulgaria

    Active - Recruiting

  • Medical Center Diamedical 2013 OOD

    Dimitrovgrad, 6400
    Bulgaria

    Active - Recruiting

  • MHAT

    Gabrovo, 5300
    Bulgaria

    Active - Recruiting

  • SBAL "Special Medic" Ltd.

    Plovdiv, 4000
    Bulgaria

    Active - Recruiting

  • UHMAT Kaspela Ltd

    Plovdiv, 4001
    Bulgaria

    Active - Recruiting

  • University Multiprofile Hospital for Active Treatment Pulmed, Clinic of Endocrinology

    Plovdiv, 4002
    Bulgaria

    Active - Recruiting

  • Medical Center Rusemed EOOD

    Ruse, 7000
    Bulgaria

    Active - Recruiting

  • UMHAT Kanev AD

    Ruse, 7002
    Bulgaria

    Active - Recruiting

  • DCC-1 Sliven Ltd.

    Sliven, 8800
    Bulgaria

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  • Medical Center Smolyan Clinical Research OOD

    Smolyan, 4700
    Bulgaria

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  • MC Doctor Kalchev OOD

    Sofia, 1700
    Bulgaria

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  • MHAT Silven to MMA Sofia

    Sofia, 8800
    Bulgaria

    Active - Recruiting

  • Medical Center Endomedical

    Sofia, 1606
    Bulgaria

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  • Medical Center Kalimat EOOD

    Sofia, 1680
    Bulgaria

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  • Medical Center for Specialized Medical Help in Cardiovascular Diseases OOD

    Sofia, 1000
    Bulgaria

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  • Medical Centre Synexus Sofia

    Sofia, 1784
    Bulgaria

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  • UMHAT Sofiamed

    Sofia, 1797
    Bulgaria

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  • Clinical of Cardiology

    Stara Zagora, 6003
    Bulgaria

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  • Medical Center Zara-Med

    Stara Zagora, 6010
    Bulgaria

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  • Diagnostic Consultative Center Equita (DCC Equita)

    Varna, 9000
    Bulgaria

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  • Specialized Hospital for Active Treatment of Cardiology

    Varna, 9020
    Bulgaria

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  • Medical Centre "Nevromedics" EOOD

    Veliko Tarnovo, 5006
    Bulgaria

    Active - Recruiting

  • Bluewater Clinical Research Group, Inc.

    Sarnia, Ontario N7T 4X3
    Canada

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  • Canadian Phase Onward Inc.

    Toronto, Ontario M3J2C5
    Canada

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  • Ecogene-21

    Chicoutimi, Quebec G7H 7K9
    Canada

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  • Clinique des Maladies Lipidiques de Quebec Inc.

    Québec, Quebec G1V 4W2
    Canada

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  • Institut de Recherches Cliniques de Montreal

    Montréal, H2W 1T7
    Canada

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  • MEDICUS SERVICES s.r.o.

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    Hradec Králové, 50005
    Czechia

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  • KardioBusak s.r.o.

    Louny, 440 01
    Czechia

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  • EDUMED s.r.o.

    Náchod, 547 01
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  • Fakultni nemocnice Ostrava

    Ostrava, 70852
    Czechia

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  • Endokrinologie Cerny Most s.r.o.

    Prague, 19800
    Czechia

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  • Vseobecna fakultni nemocnice

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    Praha, 15006
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  • Praha Poliklinika Hurka

    Praha, 158 00
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    Aalborg, 9000
    Denmark

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    Aarhus, 8200
    Denmark

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    Esbjerg, 6700
    Denmark

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  • Viborg Regional Hospital

    Viborg, 8800
    Denmark

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  • Turku University Hospital

    Turku, 20520
    Finland

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  • Louis Pradel Hospital

    Bron, 69500
    France

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    Dijon, 21079
    France

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    Marseille, 13005
    France

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    Montpellier, 34295
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    Paris, 75013
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  • CHU de Nantes - Hôpital Nord Laennec

    Saint-Herblain, 44093
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  • CHRU de Strasbourg

    Strasbourg, 67200
    France

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  • Groupement de Cooperation Sanitaire (GCS) ESLAN - Polyclinique Vauban

    Valenciennes, 59300
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  • GHM les Portes du Sud

    Vénissieux, 69200
    France

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    Berlin, 13353
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  • Universitaetsklinikum Carl Gustav Carus

    Dresden, 1307
    Germany

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  • Universitaetsklinikum Koeln

    Koeln, 50937
    Germany

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  • Forschungszentrum Ruhr

    Witten, 58455
    Germany

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  • Evangelismos General Hospital Athens

    Athens, 106 76
    Greece

    Active - Recruiting

  • Hygeia Hospital

    Athens, 15123
    Greece

    Active - Recruiting

  • Lausmed Kft

    Baja, 6500
    Hungary

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  • DRC Gyógyszervizsgáló Központ Korlátolt felelősségű társaság Balatonfüred

    Balatonfüred, 8230
    Hungary

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  • Obudai Egeszsegugyyi Centrum

    Budapest, H-1063
    Hungary

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  • Debreceni Egyetem Klinikai Központ

    Debrecen, 4032
    Hungary

    Active - Recruiting

  • Rakoczi Ferenc Korhaz

    Miskolc, H-3529
    Hungary

    Active - Recruiting

  • Dr. Vasas Szilard Haziorvosi Rendelo

    Nyíregyháza, 4405
    Hungary

    Active - Recruiting

  • Kardiologia Szakrendeles

    Nyíregyháza, H-4400
    Hungary

    Active - Recruiting

  • Medifarma-98 Kft.

    Nyíregyháza, 4400
    Hungary

    Active - Recruiting

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000
    Hungary

    Active - Recruiting

  • Vinaya Hospital and Research Centre

    Mangalore, 575003
    India

    Active - Recruiting

  • Soroka Medical Center

    Be'er Sheva, 8410101
    Israel

    Active - Recruiting

  • Bnai Zion Medical Center

    Haifa, 3104802
    Israel

    Active - Recruiting

  • The Lady Davis Carmel Medical Center

    Haifa, 3436212
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Rabin Medical Center

    Petach Tikva, 4941492
    Israel

    Active - Recruiting

  • The Chaim Sheba Medical Center

    Ramat Gan, 52621
    Israel

    Active - Recruiting

  • Kaplan Medical Center

    Reẖovot, 76100
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv,
    Israel

    Active - Recruiting

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXII

    Bergamo, 24127
    Italy

    Active - Recruiting

  • Policlinico di Sant'Orsola

    Bologna, 40138
    Italy

    Active - Recruiting

  • Asst Grande Ospedale Metropolitano Niguarda

    Milano, 20162
    Italy

    Active - Recruiting

  • Ospdale E. Bassini

    Milano, 20092
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Federico II

    Napoli, 80131
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Policlinico

    Palmero, 90127
    Italy

    Active - Recruiting

  • Department of Translational and Precision Medicine

    Rome, 00161
    Italy

    Active - Recruiting

  • Klinikiniai Sprendimai, UAB

    Kaunas, 49387
    Lithuania

    Active - Recruiting

  • Saules Seimos Medicinos Centras

    Kaunas, 49456
    Lithuania

    Active - Recruiting

  • Pulau Pinang Hospital

    Pulau Pinang, 10990
    Malaysia

    Active - Recruiting

  • Scientia Investigacion Clinical Sc

    Chihuahua, 31207
    Mexico

    Active - Recruiting

  • Centro de Investigacion Cardiometabolica S.C.

    Mexico City, 20230
    Mexico

    Active - Recruiting

  • Clinstile, S.A. de C.V.

    Mexico City, 06700
    Mexico

    Active - Recruiting

  • Academic Medical Center

    Amsterdam, 1105AZ
    Netherlands

    Active - Recruiting

  • Gelre Ziekenhuizen

    Apeldoorn, 7334 DZ
    Netherlands

    Active - Recruiting

  • Ziekenhuis Rijnstate

    Arnhem, 6815 AD
    Netherlands

    Active - Recruiting

  • Het Van Weel-Bethesda Ziekenhuis

    Dirksland, 3247 BW
    Netherlands

    Active - Recruiting

  • Ziekenhuis Gelderse Vallei

    Ede, 1001-5000
    Netherlands

    Active - Recruiting

  • Bethesda Diabetes Research Center

    Hoogeveen, 7909 AA
    Netherlands

    Active - Recruiting

  • Radboud UMC

    Nijmegen, 6525 EX
    Netherlands

    Active - Recruiting

  • Erasmus MC

    Rotterdam, 3015 GD
    Netherlands

    Active - Recruiting

  • University Medical Center Utrecht

    Utrecht, 3584 CX
    Netherlands

    Active - Recruiting

  • New Zealand Clinical Research

    Auckland, 8011
    New Zealand

    Active - Recruiting

  • New Zealand Clinical Research

    Christchurch, 8011
    New Zealand

    Site Not Available

  • Edgar Diabetes and Obesity Research Centre

    Wellington, 6021
    New Zealand

    Active - Recruiting

  • The Lipid Clinic (Oslo University Hospital)

    Oslo, 424
    Norway

    Active - Recruiting

  • Biokinetica Spolka Akcujna

    Józefów, 05-410
    Poland

    Active - Recruiting

  • Centrum Medyczne Salvia

    Katowice, 40-772
    Poland

    Active - Recruiting

  • Clinical Best Solutions

    Lublin, 20-078
    Poland

    Active - Recruiting

  • ETG Lublin

    Lublin, 20-412
    Poland

    Active - Recruiting

  • Centrum Zdrowia Metabolicznego Pawel Bogdanski

    Poznań, 60-589
    Poland

    Active - Recruiting

  • Osrodek Badan Klinicznych Metabolica

    Tarnów, 33-100
    Poland

    Active - Recruiting

  • Clinical Best Solutions Sp. z.o.o. Spolka Komandytowa

    Warsaw, 02-793
    Poland

    Active - Recruiting

  • Przychodnia Futuremeds Wroclaw

    Wrocław, 50-088
    Poland

    Active - Recruiting

  • ETG Zamosc

    Zamość, 22-400
    Poland

    Active - Recruiting

  • Instytut Centrum Zdrowia Matki Polki

    Łódź, 93-338
    Poland

    Active - Recruiting

  • Hospital Infante D. Pedro

    Aveiro, 3814-501
    Portugal

    Active - Recruiting

  • Hospital CUF Tejo

    Lisboa, 1350-352
    Portugal

    Active - Recruiting

  • Centro Hospitalar Universitario De Sao Joao

    Porto, 4200-319
    Portugal

    Active - Recruiting

  • Centro Hospitalar de Entre o Douro e Vouga, E.P.E.

    Santa Maria Da Feira, 4520-211
    Portugal

    Active - Recruiting

  • Cardioplus Center SRL

    Baia Mare, 430123
    Romania

    Active - Recruiting

  • Kardiologická ambulancia

    Brezno, 97701
    Slovakia

    Active - Recruiting

  • Cardio D&R, S.R.O. Kosice

    Košice, 040 22
    Slovakia

    Active - Recruiting

  • Human-Care s.r.o.

    Košice, 04001
    Slovakia

    Active - Recruiting

  • Vychodoslovensky Utsav srdcovych a cievnych chorob a.s.

    Košice, 04011
    Slovakia

    Active - Recruiting

  • Interna a diabetologicka ambulancia- IN- DRA- s.r.o.

    Lučenec, 984 01
    Slovakia

    Active - Recruiting

  • Diab sro

    Rožňava, 048 01
    Slovakia

    Active - Recruiting

  • Interna SK, s.r.o., Kardiologicka a interna ambulancia

    Svidník, 08901
    Slovakia

    Active - Recruiting

  • Nemocnica arm. generala L. Svobodu Svidnik, a.s

    Svidník, 08901
    Slovakia

    Active - Recruiting

  • Areteus sro

    Trebišov, 075 01
    Slovakia

    Active - Recruiting

  • Latros International

    Bloemfontein, 9301
    South Africa

    Active - Recruiting

  • Medi Clinic Vergelegen

    Cape Town, 7130
    South Africa

    Active - Recruiting

  • TREAD Research

    Cape Town, 7500
    South Africa

    Active - Recruiting

  • University of Cape Town

    Cape Town, 7700
    South Africa

    Active - Recruiting

  • Hospital Germans Trias i Pujol

    Badalona, 08916
    Spain

    Active - Recruiting

  • Hospital Clinic De Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Universitari de Bellvitge

    Barcelona, 8907
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofia

    Córdoba, 14004
    Spain

    Active - Recruiting

  • Hospital Universitario de Jaen

    Jaén, 23007
    Spain

    Active - Recruiting

  • Hospital Abente y Lago

    La Coruna, 15001
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010
    Spain

    Active - Recruiting

  • Corporacio Sanitaria Parc Tauli- Hospital de Sabadell

    Sabadell, 08208
    Spain

    Active - Recruiting

  • Hospital Virgen del Rocío

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitari Sant Joan de Reus

    Tarragona, 43204
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Sahlgrenska, University Hospital

    Göteborg, 413 45
    Sweden

    Active - Recruiting

  • Karolinska University Hospital Huddinge

    Stockholm, 14186
    Sweden

    Active - Recruiting

  • Kaohsiung Medical University Ching-Ho Memorial Hospital

    Kaohsiung, 80756
    Taiwan

    Active - Recruiting

  • Mackay Memorial Hospital

    New Taipei City, 25160
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • Shing Kong Wu Ho-Su Memorial Hospital

    Taipei City, 111
    Taiwan

    Active - Recruiting

  • Necmettin Erbakan Universitesi Meram Tip Fakultesi

    Konya, 42080
    Turkey

    Active - Recruiting

  • Hacettepe Üniversitesi Tıp Fakültesi

    Sulhiye, 06100
    Turkey

    Active - Recruiting

  • Centre for Diabetes, Endocrinology and Metabolic Disease

    Woodhurst, Chatsworth 4092
    United Kingdom

    Active - Recruiting

  • Huddersfield Royal Infirmary

    Huddersfield, England HD3 3EA
    United Kingdom

    Active - Recruiting

  • Waterloo Medical Care

    Blackpool, FY4 3AD
    United Kingdom

    Active - Recruiting

  • Hull Royal Infirmiry

    Hull, HU3 2JZ
    United Kingdom

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  • Oak Tree Surgery and Pensilva Health Centre

    Liskeard, PL14 3XA
    United Kingdom

    Active - Recruiting

  • Newquay Health Centre

    Newquay, TR7 1RQ
    United Kingdom

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  • The Adam Practice

    Poole, BH16 5PW
    United Kingdom

    Active - Recruiting

  • Sandwell and West Birmingham NHS Trust

    West Bromwich, B71 4HU
    United Kingdom

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  • University of California, San Diego (UCSD)

    San Diego, California 92161
    United States

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    Tarzana, California 91356
    United States

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    Boca Raton, Florida 33434
    United States

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    Greenacres City, Florida 33467
    United States

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    Miami, Florida 33125
    United States

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    Miami, Florida 33126
    United States

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    Miramar, Florida 33027
    United States

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    North Miami Beach, Florida 33162
    United States

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    Tampa, Florida 33634
    United States

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  • R & B Medical Center LLC

    Tampa, Florida 33614
    United States

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  • VICIS Clinical Research

    Tampa, Florida 33615
    United States

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    Trinity, Florida 34655
    United States

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    Columbus, Georgia 31904
    United States

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    Columbus, Georgia 31904
    United States

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    Columbus, Georgia 31904
    United States

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    Oak Brook, Illinois 60523
    United States

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    Carmel, Indiana 46290
    United States

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  • University of Kansas Medical Center (KUMC)

    Kansas City, Kansas 66160
    United States

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    Lexington, Kentucky 40503
    United States

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  • Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

    Louisville, Kentucky 40213
    United States

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  • Grace Research, LLC

    Bossier City, Louisiana 71111
    United States

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  • IRC Clinics

    Towson, Maryland 21204
    United States

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  • University of Michigan- Endocrinology & Metabolism

    Ann Arbor, Michigan 48109
    United States

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    Flint, Michigan 48504
    United States

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    Saint Louis, Missouri 63110
    United States

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    Lincoln, Nebraska 68506
    United States

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  • Palm Research Center, Inc.

    Las Vegas, Nevada 89128
    United States

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  • Hudson County Clinical Trials Research Center

    Union City, New Jersey 07087
    United States

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  • Modern Medical

    Brooklyn, New York 33709
    United States

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  • NYU Langone Health

    Mineola, New York 11501
    United States

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  • Langone Medical Center

    New York, New York 10016
    United States

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  • Vagelos College of Physicians and Surgeons of Columbia University

    New York, New York 10032
    United States

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  • Orchard Park Family Practice

    Orchard Park, New York 14127
    United States

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  • The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute

    Charlotte, North Carolina 28204
    United States

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  • Kenneth Hilty

    Greensboro, North Carolina 27401
    United States

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  • Clinical Trials of America, LLC

    Lenoir, North Carolina 28645
    United States

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  • Lexington

    Winston-Salem, North Carolina 27103
    United States

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  • The Ohio State University

    Columbus, Ohio 43203
    United States

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  • Central Oklahoma Early Detection Center

    Edmond, Oklahoma 73034
    United States

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  • University of Pennsylvania

    Philadelphia, Pennsylvania 19014
    United States

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  • Walker Family Care

    Little River, South Carolina 29566
    United States

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  • Health Concepts

    Rapid City, South Dakota 57702
    United States

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  • Monument Health Clinical Research

    Rapid City, South Dakota 57701
    United States

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    Chattanooga, Tennessee 37404
    United States

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    Jackson, Tennessee 38301
    United States

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  • University of Texas Southwestern

    Dallas, Texas 75390
    United States

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    Houston, Texas 77040
    United States

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    Houston, Texas 77099
    United States

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    Lampasas, Texas 76550
    United States

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  • DCT- McAllen Primary Care, LLC

    McAllen, Texas 78503
    United States

    Active - Recruiting

  • Texas Institute of Cardiology

    McKinney, Texas 75071
    United States

    Active - Recruiting

  • SMS Clinical Research, LLC

    Mesquite, Texas 75149
    United States

    Active - Recruiting

  • Southern Endocrinology Associates

    Mesquite, Texas 75149
    United States

    Active - Recruiting

  • Permian Research Foundation

    Odessa, Texas 79761
    United States

    Active - Recruiting

  • Diabetes & Glandular Disease Clinic, P.A.

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Tranquil Clinical and Research Consulting Services

    Webster, Texas 77598
    United States

    Active - Recruiting

  • Manassas Clinical Research

    Manassas, Virginia 20110
    United States

    Active - Recruiting

  • York Clinical Research

    Norfolk, Virginia 23510
    United States

    Active - Recruiting

  • WVU Heart and Vascular Institute

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

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