Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients (EURELIA2)

July 17, 2025 updated by: LG Chem

A Randomized, Multi-regional, Double-blind, Double-dummy Parallel-group, Placebo and Allopurinol-controlled Phase 3 Study to Assess the Efficacy and Safety of Tigulixostat in Gout Patients With Hyperuricemia

The aim of this 12-month randomized multi-regional double-blind parallel group allopurinol and placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2202

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1417EYG
        • Centro Privado de Medicina Familiar
      • Buenos Aires, Argentina, C1430EGF
        • Clinica Adventista Belgrano
      • Buenos Aires, Argentina, B1635
        • Hospital Universitario Austral
      • Buenos Aires, Argentina, B2900
        • Instituto de Investigaciones Clinicas San Nicolas
      • Buenos Aires, Argentina, C1015
        • Centro Médico Reumatologico - Organizacion Medica de Investigacion S.A. (OMI)
      • Buenos Aires, Argentina, C1406A
        • APRILLUS Asistencia e Investigacion Clinica
      • Córdoba, Argentina, X5000AAW
        • Instituto de Investigaciones Clinicas Cordoba
      • Córdoba, Argentina, X5000AVE
        • Centro Integral De Dianogostico por Imagenes Marchegiani (CIDIM)
      • Córdoba, Argentina, X5000EOC
        • Instituto Reumatológico Strusberg
      • Córdoba, Argentina, X5016LIG
        • Clinica Privada Velez Sarsfield (CPVS)
      • Santa Fe, Argentina, S2000PBJ
        • Instituto CAICI (Instituto Centralizado de Asistencia e Investigacion Clinica Integral)
      • Tucumán,, Argentina, T4000
        • Centro de Investigaciones Medicas Tucuman
  • Australia
      • Camberwell, Australia, 3124
        • Emeritus Research (Melbourne)
      • Darlinghurst, Australia, 2010
        • Holdsworth House Medical Practice
      • Southport, Australia, 4111
        • Griffith University Clinical Trial Unit
      • Sydney, Australia, 2019
        • Emeritus Research (Sydney)
      • Woodville South, Australia, 5011
        • The Queen Elizabeth Hospital
  • Belgium
      • Genk, Belgium, 3600
        • ReumaClinic
      • Liège, Belgium, 4000
        • CHU de Liège
      • Mons, Belgium, 7000
        • CHU HELORA - Hôpital de Mons - Site Kenedy
  • Brazil
      • Belo Horizonte, Brazil, 30150-221
        • Santa Casa de Misericordia de Belo Horizonte
      • Curitiba, Brazil, 80030-110
        • Ceti - Centro de Estudos Em Terapias Inovadoras
      • Curitiba, Brazil, 80440-080
        • EDUMED - Educação em Saúde S/S Ltda
      • Curitiba, Brazil, 90480-000
        • LMK Servicos Medicos Sociedade Simples
      • Juiz De Fora, Brazil, 36010-570
        • Cmip-Centro Mineiro de Pesquisa
      • Porto Alegre, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre
      • Salvador, Brazil, 40150-150
        • SER - Servicos Especializados em Reumatologia da Bahia
      • São Paulo, Brazil, 13015-001
        • Clinica Medica Bonfiflioli Ltda
  • Bulgaria
      • Plovdiv, Bulgaria, 4004
        • University Multiprofile Hospital for Active Treatment Plovdiv "Eurohospital" Ltd
      • Sofia, Bulgaria, 1606
        • Military Medical Academy
      • Sofia, Bulgaria, 1784
        • Medical Center Synexus Sofia EOOD
      • Sofia, Bulgaria, 1407
        • Medical Center Excelsior OOD
      • Sofia, Bulgaria, 1336
        • Mbal Lyulin EAD
      • Sofia, Bulgaria, 1463
        • DCC Fokus-5 Lzip OOD
      • Sofia, Bulgaria, 1606
        • Medical Center-N.I. Pirogov EOOD
      • Sofia, Bulgaria, 1784
        • Acibadem City Clinic Diagnostic And Consultation Center Ltd
  • Colombia
      • Bogotá, Colombia, 110221
        • Centro de Investigacion en Reumatología y Especialidades Médicas S.A.S (CIREEM S.A.S)
      • Bucaramanga, Colombia, 680003
        • Servimed S.A.S.
      • Manizales, Colombia, 170004
        • IPS Medicos Internistas de Caldas SAS
      • Zipaquirá, Colombia, 250252
        • Healthy Medical Center SAS
  • Czechia
      • Brno, Czechia, 602 00
        • MUDr. Michaela Blahova, revmatologicka ambulance s.r.o.
      • Brno, Czechia, 611 41
        • REVMACLINIC s.r.o.
      • Hlučín, Czechia, 748 01
        • L.K.N Arthrocentrum
      • Nové Město, Czechia, 128 50
        • Revmatologicky ustav
      • Uherské Hradiště, Czechia, 686 01
        • MEDICAL Plus s.r.o.
  • France
      • Bordeaux, France, 33076
        • CHU de Bordeaux
      • Lomme, France, 59160
        • Hôpital Saint Philibert
      • Lyon, France, 69003
        • Hôpital Edourad Herriot
      • Montpellier, France, 34295
        • Hopital Lapeyronie
      • Orléans, France, 45067
        • Centre Hospitalier Régional D'orléans
      • Rouen, France, 76031
        • CHU hopitaux de rouen
  • Georgia
      • Kutaisi, Georgia, 4600
        • "LJ Clinic" LTD
      • Tbilisi, Georgia, 0159
        • Tbilisi Heart and Vascular Clinic
      • Tbilisi, Georgia, 0102
        • Aleksandre Aladashvili Clinic LLC
      • Tbilisi, Georgia, 0159
        • JSC "Evex Hospitals"
      • Tbilisi, Georgia, 0112
        • LTD "Israeli-Georgian Medical Research Clinic Helsicore"
      • Tbilisi, Georgia, 0160
        • LTD MediClub Georgia
      • Tbilisi, Georgia, 0159
        • Cardioclinic - Digomi Medical Center
      • Tbilisi, Georgia, 0186
        • Multiprofile Clinic Consilium Medula LTD
  • Germany
      • Berlin, Germany, 10629
        • emovis GmbH
      • Deggingen, Germany, 73326
        • Gemeinschaftspraxis Dres. T. und N. Jung
      • Dresden, Germany, 01069
        • Klinische Forschung Dresden Gmbh
      • Essen, Germany, 45355
        • Medizentrum Essen Borbeck
      • Hamburg, Germany, 22415
        • Praxis für klinische Studien
      • Hamburg, Germany, 22143
        • Velocity Clincial Research Hamburg GmbH
      • Karlsruhe, Germany, 76137
        • Klinische Forschung Karlsruhe GmbH
      • Schwerin, Germany, 19055
        • Klinische forschung Schwerin GmbH
  • Italy
      • Alessandria, Italy, 15121
        • Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
      • Milano, Italy, 20157
        • IRCCS Ospedale Galeazzi-Sant'Ambrogio
      • Palermo, Italy, 90127
        • AOU Policlinico Paolo Giaccone
      • Reggio Emilia, Italy, 42123
        • AUSL di Reggio Emilia, Arcispedale Santa Maria Nuova-IRCCS
      • Verona, Italy, 37134
        • Azienda Ospedaliera Universitaria Integrata Verona
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Hospital
      • Gwangju, Korea, Republic of, 61469
        • Chonnam National University Hospital
      • Jeju, Korea, Republic of, 63241
        • Jeju National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06273
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of, 04763
        • Hanyang University Hospital
      • Seoul, Korea, Republic of, 02447
        • KyungHee University Hospital
      • Uijeongbu, Korea, Republic of, 11759
        • Uijeongbu Eulji Medical Cen
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Hospital of Lithuanian University of Health Sciences Kauno klinikos
      • Kaunas, Lithuania, 51270
        • Kaunas City Polyclinic, Dainava Outpatient Clinic
      • Klaipėda, Lithuania, 92288
        • Klaipeda University Hospital
  • Malaysia
      • Batu Caves, Malaysia, 68100
        • Hospital Selayang
      • Kuala Lumpur, Malaysia, 50603
        • University Malaya Medical Centre
      • Kuala Lumpur, Malaysia, 53200
        • Klinik Kesihatan Kuang Lumpur
      • Kuching, Malaysia, 93586
        • Hospital Umum Sarawak
      • Masjid Tanah, Malaysia, 78300
        • Klinik Kesihatan Masjid Tanah
      • Miri, Malaysia, 98000
        • Hospital Miri
      • Rawang, Malaysia, 48050
        • Klinik Kesihatan Kuang
      • Seri Manjung, Malaysia, 32040
        • Hospital Seri Manjung
  • New Zealand
      • Auckland, New Zealand, 2025
        • Aotearoa Clinical Trials
      • Auckland, New Zealand, 0600
        • Southern Clinical Trials Totara
      • Auckland, New Zealand, 0932
        • PCRN Silverdale Medical Centre
      • Christchurch, New Zealand, 8013
        • Pacific Clinical Research Network (PCRN) Clinical Trials
      • Hamilton, New Zealand, 3204
        • Waikato Hospital
      • Hamilton, New Zealand, 3200
        • Lakeland Clinical Trials Waikato
      • Nelson, New Zealand, 7011
        • Southern Clinical Trials Tasman
      • Rotorua, New Zealand, 3010
        • Pacific Clinical Research Network (PCRN) - Rotorua
      • Wellington, New Zealand, 6021
        • Wellington Regional Hospital
      • Wellington, New Zealand, 5018
        • Lakeland Clinical Trials Wellington
  • Philippines
      • Angeles, Philippines, 2009
        • Angeles University Foundation Medical Center
      • Baguio, Philippines, 2600
        • Baguio General Hospital and Medical Center
      • Cebu, Philippines, 6000
        • Cebu Doctors' University Hospital
      • Dasmariñas, Philippines, 4114
        • De La Salle Medical and Health Sciences Institute
      • Davao City, Philippines, 8000
        • Davao Doctors Hospital
      • Iloilo City, Philippines, 5000
        • Iloilo Doctors' Hospital Inc
      • Iloilo City, Philippines, 5000
        • St. Paul's Hospital of Iloilo
      • Lipa, Philippines, 4217
        • Lipa Medix Medical Center
      • Makati, Philippines, 1229
        • Makati Medical Center
      • Makati, Philippines, 1210
        • Ospital ng Makati
      • Manila, Philippines, 1000
        • Manila Doctors Hospital
      • Manila, Philippines, 1000
        • Medical Center Manila
      • Manila, Philippines, 1014
        • Chinese General Hospital and Medical Center
      • Manila, Philippines, 1000
        • University of the Philippines - Philippine General Hospital
  • Poland
      • Białystok, Poland, 15-879
        • ClinicMed Daniluk, Nowak Spdtka komandytowa
      • Elbląg, Poland, 82-300
        • Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka partnerska
      • Kraków, Poland, 30-149
        • Malopolskie Centrum Kliniczne
      • Kraków, Poland, 31-513
        • Centrum Medyczne Promed
      • Kraków, Poland, 30-727
        • Pratia MCM Krakow
      • Lublin, Poland, 20-607
        • Zespol Poradni Specjalistycznych REUMED, Filia nr 1 Wallenroda
      • Olsztyn, Poland, 10-117
        • ETYKA - Ośrodek Badań Klinicznych
      • Warszawa, Poland, 02-637
        • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
      • Warszawa, Poland, 00-215
        • FutureMeds Warszawa Centrum
      • Warszawa, Poland, 00-874
        • MICS Centrum Medyczne Warszawa
      • Warszawa, Poland, 03-291
        • FutureMeds Targéwek
      • Wrocław, Poland, 50-244
        • Reum-Medica s.c. Bozena Kowalewska, Marek Zawadzki
      • Łódź, Poland, 90-368
        • SOMED CR
  • Spain
      • A Coruña, Spain, 15006
        • Hospital Universitario de A Coruña
      • A Coruña, Spain, 15705
        • HM Hospital Nuestra Señora de la Esperanza
      • A Coruña, Spain, 15706
        • Hospital Clinico Universitario de Santiago de Compostela (CHUS)
      • Barcelona, Spain, 08041
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spain, 08907
        • Hospital De Bellvitge
      • Barcelona, Spain, 08034
        • Hospital Sanitas CIMA
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofía
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor
      • Santiago De Compostela, Spain, 15702
        • Clínica Gaias Santiago
      • Sevilla, Spain, 41013
        • Hospital Quirónsalud Sagrado Corazón
      • Vigo, Spain, 36214
        • Hospital Do Meixoeiro
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital
      • Taichung City, Taiwan, 40201
        • Chung Shan Medical University Hospital
      • Taichung City, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taichung City, Taiwan, 404327
        • China Medical University Hospital
      • Tainan City, Taiwan, 71004
        • Chi Mei Medical Center
      • Taoyuan City, Taiwan, 33305
        • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
  • Thailand
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital
      • Bangkok, Thailand, 10700
        • Siriraj Hospital
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital
      • Bangkok, Thailand, 10330
        • Phramongkutklao Hospital
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital
      • Khlong Luang, Thailand, 12120
        • Thammasat University Hospital
      • Songkhla, Thailand, 90110
        • Songklanagarind Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham
      • Daphne, Alabama, United States, 36526
        • Alliance for Multispecialty Research, LLC
      • Mobile, Alabama, United States, 36608
        • Alliance for Multispecialty Research, LLC
      • Muscle Shoals, Alabama, United States, 35661
        • Syed Research Consultants, LLC
      • Sheffield, Alabama, United States, 35660
        • Syed Research Consultants, LLC
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Arizona Research Clinic, PLLC
      • Flagstaff, Arizona, United States, 86001
        • Arizona Arthritis & Rheumatology Associates, P.C.
      • Glendale, Arizona, United States, 85306
        • Arizona Arthritis and Rheumatology Research PLLC
      • Mesa, Arizona, United States, 85210
        • Arizon Arthritis & Rheumatology Research, PLLC
      • Mesa, Arizona, United States, 85213
        • Desert Clinical Research/CCT Research
      • Phoenix, Arizona, United States, 85018
        • Elite Clinical Studies, LLC
      • Tempe, Arizona, United States, 85283
        • Fiel Family and Sports Medicine/CCT Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Lynn Institute of the Ozarks
    • California
      • Banning, California, United States, 92220
        • Velocity Clinical Research
      • Buena Park, California, United States, 90620
        • American Clinical Trials
      • Lakewood, California, United States, 90805
        • Shreenath Clinical Service
      • Rancho Cucamonga, California, United States, 91730
        • Rancho Cucamonga Clinical Research
      • San Diego, California, United States, 92128
        • Rheumatology Center of San Diego
      • San Diego, California, United States, 92108
        • TriWest Research Associates
    • Florida
      • Aventura, Florida, United States, 33180
        • Arthritis & Rheumatic Disease Specialties
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc.
      • Coral Gables, Florida, United States, 33134
        • Herco Medical and Research Center, Inc
      • Cutler Bay, Florida, United States, 33189
        • Nouvelle Clinical Research LLC
      • DeBary, Florida, United States, 32713
        • Omega Research Debary, LLC
      • Fort Myers, Florida, United States, 33912
        • Alliance for Multispecialty Research, LLC
      • Hialeah, Florida, United States, 33012
        • Direct Helpers Research Center
      • Hialeah, Florida, United States, 33016
        • Vital Pharma Research
      • Hialeah, Florida, United States, 33016
        • Best Quality Research, Inc
      • Hialeah, Florida, United States, 33016
        • New Generation Of Medical Research, LLC
      • Lake Mary, Florida, United States, 32746
        • Accel Research Sites - Lakeland
      • Lake Mary, Florida, United States, 32746
        • Accel Research Sites - St. Petersburg- Largo
      • Lake Mary, Florida, United States, 32746
        • ARS-Matiland Clinical Research Unit
      • Miami, Florida, United States, 33175
        • Pharmax Research of South Florida, Inc
      • Miami, Florida, United States, 33155
        • Allied Biomedical Research Institute
      • Miami, Florida, United States, 33176
        • Miami Dade Medical Research Institute, LLC
      • Miami, Florida, United States, 33175
        • Care Research Center Inc
      • Miami, Florida, United States, 33155
        • Ivetmar Medical Group, LLC
      • Miami, Florida, United States, 33032
        • Homestead Associates in Research,Inc
      • Miami, Florida, United States, 33186
        • Clinical Site Partners, LLC dba Flourish Research
      • Miami, Florida, United States, 33155
        • D&H National Research Centers, Inc.
      • Miami, Florida, United States, 33186
        • M&A Medical Centers and Research
      • Orlando, Florida, United States, 32819
        • HMD Research LLC
      • Saint Petersburg, Florida, United States, 33709
        • Ima Clinical Research
      • Tampa, Florida, United States, 33613
        • Forcare Clinical Research
      • Tampa, Florida, United States, 33606
        • Clinical Research of West Florida, Inc.
      • Tampa, Florida, United States, 33607
        • Clinical Research Trials of Florida, Inc.
      • Tampa, Florida, United States, 32757
        • Adult Medicine of Lake County, Inc.
      • Tampa, Florida, United States, 33173
        • Research Institute of South Florida, Inc.
      • Tampa, Florida, United States, 33607
        • Nodal Medical Center
      • Winter Park, Florida, United States, 32789
        • Conquest Research
      • Winter Park, Florida, United States, 32789
        • Clinical Site Partners LLC dba CSP Orlando
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Centricity Research
      • Gainesville, Georgia, United States, 30501
        • Arthritis Center of North Georgia
      • Newnan, Georgia, United States, 30265
        • Vista Clinical Research, LLC
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East West Medical Research Institute
    • Idaho
      • Boise, Idaho, United States, 83713
        • Family Care Research, LLC
      • Meridian, Idaho, United States, 83642
        • Alliance for Multispecialty Research, LLC
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials
      • Chicago, Illinois, United States, 60602
        • IMA Research, Inc.
      • Flossmoor, Illinois, United States, 60422
        • Healthcare Research Network II, LLC
      • Gurnee, Illinois, United States, 60031
        • Clinical Investigation Specialists, Inc
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Medisphere Medical Research Center, Llc
      • Franklin, Indiana, United States, 46131
        • American Health Network of Indiana, LLC
      • Muncie, Indiana, United States, 47304
        • American Health Network of Indiana LLC
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Integrated Clinical Trial Services Inc.
    • Kansas
      • Shawnee Mission, Kansas, United States, 66218
        • Women's & Family Care LLC, dba GTC Research
      • Wichita, Kansas, United States, 67207
        • Alliance for Multispecialty Research, LLC
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Alliance for Multispecialty Research, LLC
      • Versailles, Kentucky, United States, 40383
        • Versailles Family Medicine
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Clinical Trials Management, LLC
      • Metairie, Louisiana, United States, 70006
        • Clinical Trials Management
    • Maryland
      • Oxon Hill, Maryland, United States, 20745
        • MD Medical Research
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Elite Clinical Research, LLC
      • Olive Branch, Mississippi, United States, 38654
        • Olive Branch Family Medical Center
      • Port Gibson, Mississippi, United States, 39150
        • Practice Dr David Headley
    • Missouri
      • Hazelwood, Missouri, United States, 63042
        • Healthcare Research Network
      • Kansas City, Missouri, United States, 64114
        • Alliance for Multispecialty Research, LLC
      • Kansas City, Missouri, United States, 64151
        • Clay-Platte Family Medicine Clinic
      • Saint Louis, Missouri, United States, 63117
        • Ima Clinical Research
      • Saint Louis, Missouri, United States, 63119
        • St. Louis Medical Professionals, LLC
    • Montana
      • Missoula, Montana, United States, 59808
        • Montana Medical Research, Inc.
    • Nebraska
      • Fremont, Nebraska, United States, 68025
        • Methodist Physicians Clinic/CCT Research
      • Norfolk, Nebraska, United States, 68701
        • Meridian Clinical Research, LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Alliance for Multispecialty Research, LLC.
      • Las Vegas, Nevada, United States, 89102
        • Healor Primary Care /CCT Research
      • Las Vegas, Nevada, United States, 89118
        • Wake Research - CRCN
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Center for Rheumatology
      • Santa Fe, New Mexico, United States, 87505
        • Inspire Santa Fe Medical Group
    • New York
      • Babylon, New York, United States, 11702
        • Long Island Regional Arthritis & Osteoporosis Care PC
      • New York, New York, United States, 10036
        • Ima Clinical Research
      • Vestal, New York, United States, 13850
        • Conquest Research
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Presbyterian Hospital
      • Greensboro, North Carolina, United States, 27410
        • Triad Clinical Trials, LLC
      • Hendersonville, North Carolina, United States, 28792
        • Olympus Family Medicine
      • Morganton, North Carolina, United States, 28655
        • Burke Primary Care
      • Shelby, North Carolina, United States, 28150
        • Carolina Research Center, Inc.
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Lillestol Research LLC
      • Minot, North Dakota, United States, 58701
        • Trinity Health Center Medical Arts
    • Ohio
      • Perrysburg, Ohio, United States, 43551
        • Arthritis Associates of Northwest Ohio Inc.
      • Vandalia, Ohio, United States, 45377
        • Stat Research
    • Pennsylvania
      • Hatboro, Pennsylvania, United States, 19040
        • Hatboro Medical Associates, P.C.
      • Philadelphia, Pennsylvania, United States, 19114
        • Tristar Clinical Investigations, P.C.
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Alliance for Multispecialty Research, LLC
      • Knoxville, Tennessee, United States, 37909
        • New Phase Research
    • Texas
      • Baytown, Texas, United States, 77521
        • Inquest Clinical Research
      • Colleyville, Texas, United States, 76034
        • PCCR Solutions
      • Dallas, Texas, United States, 75231
        • Metroplex Clinical Research Center
      • Dallas, Texas, United States, 75234
        • DFW Clinical Research
      • Fort Worth, Texas, United States, 76177
        • Dallas Fort Worth Clinical Research Associates
      • Houston, Texas, United States, 77099
        • Pioneer Research Solutions, Inc.
      • Mesquite, Texas, United States, 75150
        • SouthWest Rheumatology Research, LLC
      • Plano, Texas, United States, 75093
        • AIM Trials, LLC
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc.
      • Sugar Land, Texas, United States, 77479
        • Sugar Lakes Family Practice, PA
      • Tomball, Texas, United States, 77375
        • DM Clinical Research
      • Tomball, Texas, United States, 77377
        • DM Clinical Research
    • Utah
      • Bountiful, Utah, United States, 84010
        • Cope Family Medicine/CCT Research
      • Salt Lake City, Utah, United States, 84117
        • Olympus Family Medicine
      • Salt Lake City, Utah, United States, 84124
        • Highland Clinical Research
      • South Ogden, Utah, United States, 84405
        • South Ogden Family Medicine clinic
      • West Jordan, Utah, United States, 84088
        • Velocity Clinical Research, Salt Lake City
    • Virginia
      • Portsmouth, Virginia, United States, 23703
        • Meridian Clinical Research, LLC
      • Richmond, Virginia, United States, 23219
        • Dominion Medical Associates, Inc.
    • Washington
      • Spokane, Washington, United States, 99204
        • Arthritis Northwest, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female subjects between the ages of 18 85 years, inclusive.
  • Subjects with hyperuricemia and a history or presence of gout per American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2015 criteria.
  • Subjects who are currently on urate-lowering therapies (ULT) with an sUA level ≥6.0 mg/dL at screening (Visit 1); or subjects who are currently not on ULT with an sUA level ≥7.0 mg/dL at screening (Visit 1). Subjects currently on ULT will undergo washout and must have an sUA level ≥7.0 mg/dL at Visit 3 to be randomized and participate in the study.
  • Subjects with a Body Mass Index ≤50 kg/m2 and estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at screening (Visit 1).

Exclusion Criteria:

  • Subjects with secondary hyperuricemia and enzymatic defects.
  • Subjects experiencing an acute gout attack (intense pain, swelling, or/and tenderness in the joint area) within 2 weeks prior to screening (Visit 1).
  • Subjects who have received pegloticase to treat gout which has not responded to the usual treatments.
  • Subjects who have not been receiving stable doses of drugs known to affect sUA levels for the last 3 weeks prior to screening (Visit 1).
  • Subjects with a history of xanthinuria (elevated levels of xanthine in the urine).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tigulixostat 100mg
Tigulixostat 100mg, Once a day (QD) for up to 12 months
Drug: Tigulixostat
Xanthine Oxidase Inhibitor
Other Names:
  • LC350189
Experimental: Tigulixostat 200mg
Tigulixostat 200mg, Once a day (QD) for up to 12 months
Drug: Tigulixostat
Xanthine Oxidase Inhibitor
Other Names:
  • LC350189
Active Comparator: Titrated allopurinol (100-800mg)
Allopurinol 100-800mg, three times a day (TID) for up to 12 months. The allopurinol dose will be increased in 100 mg increments up to 800mg.
Drug: Allopurinol
Xanthine Oxidase Inhibitor
Placebo Comparator: Placebo
Placebo, three times a day (TID) for up to 6 months.
Drug: Placebo
Matching placebo
Experimental: Tigulixostat 300mg
Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 12 months
Drug: Tigulixostat
Xanthine Oxidase Inhibitor
Other Names:
  • LC350189

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6
Time Frame: Up to Month 6
Serum uric acid (sUA) level will be measured at Month 4,5, and 6
Up to Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of subjects with sUA levels <5.0 mg/dL sustained at months 4, 5, and 6
Time Frame: Up to Month 6
Serum uric acid (sUA) level will be measured at Month 4,5, and 6
Up to Month 6
Proportion of subjects with at least one gout flare from Month 6 to Month 12.
Time Frame: From Month 6 to Month 12
Gout flare (intense pain, swelling, or/and tenderness in the joint area) will be assessed from baseline up to 12 months
From Month 6 to Month 12
Proportion of subjects with complete resolution of ≥1 target tophus by Month 12
Time Frame: Up to Month 12
Tophi will be measured by independent central blind reader
Up to Month 12
Incidence rate of adverse event
Time Frame: Up to Month 12
Safety assessment
Up to Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Chem

Investigators

  • Study Director: Hyungjin Cho, MD, LG Chem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2023

Primary Completion (Actual)

May 6, 2025

Study Completion (Actual)

May 6, 2025

Study Registration Dates

First Submitted

October 16, 2022

First Submitted That Met QC Criteria

October 16, 2022

First Posted (Actual)

October 19, 2022

Study Record Updates

Last Update Posted (Actual)

July 22, 2025

Last Update Submitted That Met QC Criteria

July 17, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-GDCL010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hyperuricemia

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe