A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

Last updated: January 27, 2025
Sponsor: Ionis Pharmaceuticals, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Hypertriglyceridemia

Treatment

Placebo

Olezarsen

Clinical Study ID

NCT05552326
ISIS 678354-CS6
2022-501420-20
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification

  2. Participants must be on lipid-lowering therapy that should adhere to standard ofcare (SOC) per local guidelines. Lipid-lowering medications should be optimized andstabilized for at least 4 weeks prior to screening to minimize changes in thesemedications during the study.

  3. Participants must be willing to comply with diet and lifestyle recommendations asable.

Exclusion

Exclusion Criteria:

  1. Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening

  2. Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal

  3. Total bilirubin > 1.5 ULN unless due to Gilbert's syndrome

  4. Estimated GFR < 30 mL/min/1.73 m^2

Study Design

Total Participants: 446
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
August 31, 2022
Estimated Completion Date:
September 30, 2025

Study Description

This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study in 446 participants. Participants will be randomized to receive olezarsen or placebo in a 53-week treatment period. The length of participation in the study will be approximately 78 weeks, which includes an up to 12-week screening period, a 53-week treatment period, and a 13-week post-treatment evaluation period or transition to open-label extension (OLE) study with up to 1-year treatment.

Connect with a study center

  • Centro Médico Dra. Laura Maffei

    Buenos Aires, C1425AGC
    Argentina

    Site Not Available

  • Glenny Corp SA

    Buenos Aires, C1430
    Argentina

    Site Not Available

  • CIPREC - Centro de Investigación y Prevención Cardiovascular

    Ciudad Autónoma de Buenos Aires, C1061AAG
    Argentina

    Site Not Available

  • Fundacion Favaloro

    Ciudad Autónoma de Buenos Aires, C1093AAS
    Argentina

    Site Not Available

  • Instituto de Cardiología Corrientes

    Corrientes, W3400CDS
    Argentina

    Site Not Available

  • Instituto Médico DAMIC

    Córdoba, X5003DCE
    Argentina

    Site Not Available

  • Centro Medico San Luis

    San Luis, D5700
    Argentina

    Site Not Available

  • Clínica FUSAVIM Privada

    Villa María, X5900JKA
    Argentina

    Site Not Available

  • AZ Sint-Jan Brugge

    Brugge, 8000
    Belgium

    Site Not Available

  • Hôpital Erasme

    Brussels, 1070
    Belgium

    Site Not Available

  • Virga Jessa Hospital

    Hasselt, 3500
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • NUPEC - Nucleo de Pesquisa Clinica

    Belo Horizonte, 30220-140
    Brazil

    Site Not Available

  • Núcleo de Pesquisa Clínica

    Curitiba, 80730-150
    Brazil

    Site Not Available

  • Hospital Universitario Walter Cantidio - UFC

    Fortaleza, 60430-270
    Brazil

    Site Not Available

  • Nucleo de Pesquisa em Cirurgia Vascular

    Porto Alegre, 90035-903
    Brazil

    Site Not Available

  • IBPClin Pesquisa Clinica

    Rio De Janeiro, 20241-180
    Brazil

    Site Not Available

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - FMUSP

    Sao Paulo, 05403-900
    Brazil

    Site Not Available

  • CPQuali Pesquisa Clinica

    São Paulo, 01228-000
    Brazil

    Site Not Available

  • Instituto do Coração - HCFMUSP

    São Paulo, 05403-000
    Brazil

    Site Not Available

  • i9 Pesquisas Clínicas/Loema - Instituto de Pesquisas Clínica & Consultores

    São Paulo, 13092-133
    Brazil

    Site Not Available

  • Medical Center Diamedical EOOD

    Dimitrovgrad, 6400
    Bulgaria

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  • MHAT Haskovo AD

    Haskovo, 6304
    Bulgaria

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  • MHAT Pazardzhik AD

    Pazardzhik, 4400
    Bulgaria

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  • UMHAT - Kaspela EOOD

    Plovdiv, 4000
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment Pulmed OOD

    Plovdiv, 4000
    Bulgaria

    Site Not Available

  • UMHAT Kanev AD

    Ruse, 7002
    Bulgaria

    Site Not Available

  • MHAT Sliven to MMA Sofia

    Sliven, 8800
    Bulgaria

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  • Medical Center Smolyan Clinical Research OOD

    Smolyan, 4700
    Bulgaria

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  • Acibadem City Clinic Tokuda University Hospital

    Sofia, 1407
    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 EOOD

    Sofia, 1784
    Bulgaria

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  • Medico Dental Center ISUL Tsaritsa Yoanna EOOD

    Sofia, 1527
    Bulgaria

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    Stara Zagora, 6000
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    Varna, 9000
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    Varna, 9000
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  • Medical Centre "Nevromedics" EOOD

    Veliko Tarnovo, 5006
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  • NL Health Services

    Saint John's, Newfoundland and Labrador A1B 3V6
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  • Aggarwal and Associates Ltd.

    Brampton, Ontario L6T 0G1
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  • Joanne F. Liutkus Medicine Professional Corporation

    Cambridge, Ontario N3H 4L5
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  • Bluewater Clinical Research Group

    Sarnia, Ontario N7t 4X3
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  • Toronto General Hospital

    Toronto, Ontario M5G2C4
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  • Unite de Recherche Clinique

    St Jerome, Quebec J7Z 2V4
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  • CTC Hodonin s.r.o.

    Hodonín, 695 01
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    Louny, 440 01
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  • Fakultni nemocnice v Motole

    Prague, 150 06
    Czechia

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  • Endokrinologie Cerny Most s.r.o.

    Praha, 198 00
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  • Diabetologická a endokrinologická ambulance Milan Kvapil

    Příbram, 267 01
    Czechia

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  • AeskuLab k.s

    Teplice, 415 01
    Czechia

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  • Hopital de Hautepierre

    Strasbourg, 67098
    France

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  • ELSAN - Polyclinique Vauban

    Valenciennes, 59300
    France

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  • GHM les Portes du Sud

    Vénissieux, 69200
    France

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  • University General Hospital of Alexandroupoli

    Alexandroupoli, 68100
    Greece

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  • AHEPA Building of Evaggelismos

    Athens, 10676
    Greece

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  • Hygeia Hospital

    Athens, 15123
    Greece

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    Athens, 12462
    Greece

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    Thessaloníki, 54636
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    Baja, H-6500
    Hungary

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    Balatonfured, H-8230
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    Budapest, H1033
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    Budapest, H-1036
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    Kaposvár, H-7400
    Hungary

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    New Delhi, Delhi 110017
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    Kolkata, West Bengal 700027
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    Bengaluru, 560069
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    Delhi, 110060
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    Jaipur, 302017
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    Mumbai, 400007
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    Mumbai, 4000012
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    Mysore, 570015
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    Bergamo, 24127
    Italy

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    Caserta, 81100
    Italy

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  • Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna

    Cona, 44124
    Italy

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  • Fondazione I.R.C.C.S. Policlinico "San Matteo" c/o C.U.R.M.

    Pavia, 27100
    Italy

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  • Klinikiniai sprendimai

    Kaunas, LT-49387
    Lithuania

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  • Saules seimons medicinos centras

    Kaunas, 49449
    Lithuania

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  • Clinic of Cardiology and Rehabilitation

    Klaipėda, LT-91131
    Lithuania

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  • Republican Panevezys Hospital

    Panevėžys, LT-35144
    Lithuania

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  • Pirmoji viltis

    Šiauliai, LT-76206
    Lithuania

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  • Sultanah Bahiyah Hospital

    Alor Setar, Kedah 05460
    Malaysia

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  • Hospital Taiping

    Taiping, Perak 34000
    Malaysia

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  • Pulau Pinang Hospital

    George Town, Pulau Pinang 10450
    Malaysia

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  • University Malaya Medical Centre (UMMC)

    Kuala Lumpur, 59100
    Malaysia

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  • Medical Care and Research S.A de C.V.

    Mérida, Yucatan 97070
    Mexico

    Site Not Available

  • Centro de Investigación Cardiométabolica de Aguascalientes S.A. de C.V.

    Aguascalientes, 20230
    Mexico

    Site Not Available

  • Cientia Investigacion Clinica Sc

    Chihuahua, 32103
    Mexico

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  • Clinstile, S.A. de C.V.

    Mexico City, 06700
    Mexico

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  • Clinical Research Institute S.C.

    Tlanepantla, 54055
    Mexico

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  • Vumc Amsterdam Medical Center

    Amsterdam, 1081BT
    Netherlands

    Site Not Available

  • Gelre Ziekenhuizen Apeldoorn

    Apeldoorn, 7334 DZ
    Netherlands

    Site Not Available

  • Reinier de Graaf Ziekenhuis

    Delft, 2625 AD
    Netherlands

    Site Not Available

  • Het Van Weel Bethesda ziekenhuis

    Dirksland, 3247BW
    Netherlands

    Site Not Available

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3318 AT
    Netherlands

    Site Not Available

  • Bethesda Diabetes Research Center

    Hoogeveen, 7909 AA
    Netherlands

    Site Not Available

  • Canisius-Wilhelmina Ziekenhuis (CWZ)

    Nijmegen, 6532 SZ
    Netherlands

    Site Not Available

  • UCK, I Klinika Kardiologii

    Gdańsk, 80-214
    Poland

    Site Not Available

  • Biokinetica

    Józefów, 05-410
    Poland

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  • Centrum Medyczne Pratia

    Katowice, 40-081
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    Lublin, 20-078
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  • Etg Lublin

    Lublin, 20-412
    Poland

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  • Centrum Zdrowia Metabolicznego

    Poznan, 60-589
    Poland

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  • Centrum Medycnze AMED

    Warsaw, 03-291
    Poland

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

    Warsaw, 00-710
    Poland

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  • Narodowy Instytut Kardiologii im. S. Wyszyńskiego - PIB

    Warszawa, 04-628
    Poland

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  • ETG Zamosc / Pro Life Medica Sp. z o.o.

    Zamość, 22-400
    Poland

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  • Centra Medyczne Medyceusz

    Łódź, 91-053
    Poland

    Site Not Available

  • Hospital CUF Tejo

    Lisboa, 1350-352
    Portugal

    Site Not Available

  • Centro Hospitalar de Entre Douro e Vouga

    Santa Maria Da Feira, 4520-211
    Portugal

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  • Cabinet Medical Individual SC DIANA BARBONTA SRL

    Alba, 510053
    Romania

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  • Cardioplus Center SRL

    Baia Mare, 430123
    Romania

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  • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed S.R.L

    Braşov, 500283
    Romania

    Site Not Available

  • Centrul Medical Medicover Victoria

    Bucuresti, 10626
    Romania

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  • S.C. SAL MED S.R.L., Cardiologie

    Piteşti, 10437
    Romania

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  • Cardio Med SRL

    Târgu-Mureş, 540124
    Romania

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  • S.C. Mediab Srl

    Târgu-Mureş, 540142
    Romania

    Site Not Available

  • Alian s.r.o.

    Bardejov, 08501
    Slovakia

    Site Not Available

  • Ambulancia diabetologicka a poruch latkovej premeny a vyzivy

    Bratislava, 83106
    Slovakia

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

    Lučenec, 98401
    Slovakia

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  • Diab sro

    Rožňava, 04801
    Slovakia

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  • Interna SK, s.r.o.

    Svidník, 08901
    Slovakia

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  • Areteus s.r.o

    Trebišov, 07501
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  • Hospital Germans Trias i Pujol

    Badalona, 8916
    Spain

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  • Hospital Vall d'Hebron

    Barcelona, 8035
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  • Hospital Comarcal Infanta Elena

    Huelva, 21007
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  • Hospital Universitario de Jaen

    Jaén, 23007
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  • Hospital Universitario 12 de Octubre

    Madrid, 28041
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  • Hospital Regional de Malaga

    Malaga, 29009
    Spain

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  • Unidad de Ensayos Clinicos

    Malaga, 29010
    Spain

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  • Hospital Provincial de Conxo

    Santiago De Compostela, 15706
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  • Hospital Universitario Virgen Macarena

    Sevilla, 41009
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    Valencia, 46010
    Spain

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  • Hospital Universitario Miguel Servet

    Zaragoza, 50009
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  • Acardo MedSite

    Solna, SE-171 64
    Sweden

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  • Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

    Kaohsiung, 80756
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  • Mackay Memorial Hospital

    New Taipei City, 251404
    Taiwan

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  • Taichung Veterans General Hospital

    Taichung City, 40705
    Taiwan

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  • National Cheng Kung University Hospital

    Tainan, 704017
    Taiwan

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  • Shin Kong Wu Ho-Su Memorial Hospital

    Taipei City, 111045
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation - Linkou Branch

    Taoyuan, 33305
    Taiwan

    Site Not Available

  • Alabama Clinical Therapeutics, LLC Alabaster

    Birmingham, Alabama 35235
    United States

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  • Central Research Associates, Inc.

    Birmingham, Alabama 35205
    United States

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  • Onyx Clinical Research

    Peoria, Arizona 85381
    United States

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  • NRC Research Institute

    Los Angeles, California 90015
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  • Accel Research Sites

    DeLand, Florida 32720
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  • Finlay Medical Research

    Greenacres City, Florida 33467
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  • University of Florida Jacksonville

    Jacksonville, Florida 32209
    United States

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  • Meridien Research

    Maitland, Florida 32751
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  • Columbus Clinical Services

    Miami, Florida 33125
    United States

    Site Not Available

  • Harmony Clinical Research, Inc

    North Miami Beach, Florida 33162
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  • Combined Research Orlando Phase I-IV

    Orlando, Florida 32807
    United States

    Site Not Available

  • 3Sync Research

    Sunrise, Florida 33325
    United States

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  • JSV Clinical Research Study, Inc.

    Tampa, Florida 33634
    United States

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  • R & B Medical Center LLC

    Tampa, Florida 33614
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  • Metabolic Research Institute

    West Palm Beach, Florida 33401
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  • Emory University

    Atlanta, Georgia 30322
    United States

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    Eatonton, Georgia 31024
    United States

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  • Northeast Georgia Medical Center

    Gainesville, Georgia 30501
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    Newnan, Georgia 30265
    United States

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    Carmel, Indiana 46290
    United States

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    Kansas City, Kansas 66160
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  • The Research Group of Lexington, LLC

    Lexington, Kentucky 40503
    United States

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    Louisville, Kentucky 40213
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    Louisville, Kentucky 40202
    United States

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  • Grace Research, LLC

    Bossier City, Louisiana 71111
    United States

    Site Not Available

  • Clinical Trials of America LA, LLC

    Monroe, Louisiana 71201
    United States

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    Baltimore, Maryland 21229
    United States

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    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

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  • Onyx Clinical Research

    Flint, Michigan 48532
    United States

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    Rochester Hills, Michigan 48307
    United States

    Site Not Available

  • Stern Cardiovascular

    Southaven, Mississippi 38671
    United States

    Site Not Available

  • NYU Langone Hospital - Long Island

    Mineola, New York 11501
    United States

    Site Not Available

  • Orchard Park Family Practice

    Orchard Park, New York 14127
    United States

    Site Not Available

  • Clinical Trials of America, LLC

    Lenoir, North Carolina 28645
    United States

    Site Not Available

  • Diabetes and Endocrinology Consultants, P.C.

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • OnSite Clinical Solutions, LLC

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • The Ohio State University (OSU)

    Columbus, Ohio 43203
    United States

    Site Not Available

  • SV Research LLC

    Marion, Ohio 43302
    United States

    Site Not Available

  • Oklahoma Heart Institute

    Tulsa, Oklahoma 74133
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Main Street Physicians Care Waterway

    Little River, South Carolina 29566
    United States

    Site Not Available

  • Monument Health Clinical Research

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • The Jackson Clinic

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Texas Health Family Care

    Fort Worth, Texas 76107
    United States

    Site Not Available

  • Clinical Trial Network

    Houston, Texas 77074
    United States

    Site Not Available

  • Juno Research

    Houston, Texas 77040
    United States

    Site Not Available

  • Pioneer Research Solutions, Inc

    Houston, Texas 77099
    United States

    Site Not Available

  • Vilo Research Group

    Houston, Texas 77017
    United States

    Site Not Available

  • Sante Clinical Research, LLC

    Kerrville, Texas 78028
    United States

    Site Not Available

  • FMC Science

    Lampasas, Texas 76550
    United States

    Site Not Available

  • DCT - McAllen Primary Care, LLC

    McAllen, Texas 78503
    United States

    Site Not Available

  • McAllen Primary Care, LLC

    McAllen, Texas 78503
    United States

    Active - Recruiting

  • Texas Institute of Cardiology

    McKinney, Texas 75071
    United States

    Site Not Available

  • SMS Clinical Research, LLC

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Southern Endocrinology Associates

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Permian Research Foundation

    Odessa, Texas 79761
    United States

    Site Not Available

  • Diabetes & Glandular Disease Clinic, P.A.

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Tranquil Research

    Webster, Texas 77598
    United States

    Site Not Available

  • Aspen Clinical Research

    Orem, Utah 84058
    United States

    Site Not Available

  • Ogden Clinic Grandview

    Roy, Utah 84401
    United States

    Site Not Available

  • Clinical Investigation Specialists Inc.

    Kenosha, Wisconsin 53144
    United States

    Site Not Available

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