Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients (EURELIA1)

A Randomized, Multi-regional, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study to Assess the Safety and Efficacy of 6 Months Treatment With Tigulixostat in Gout Patients With Hyperuricemia

The aim of this 6-month randomized multi-regional double-blind parallel group 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: Hyperuricemia; Gout; Gout Flare; Tophi
• Intervention / Treatment: Drug: Placebo; Drug: Tigulixostat

• Study Type: Interventional
• Enrollment (Actual): 354
• Phase: Phase 3

Contacts and Locations

Study Locations

• Georgia
  • Kutaisi, Georgia, 4600
    • LTD "Clinic LJ"
  • Tbilisi, Georgia, 0186
    • ltd Multiprofile Clinic Consilium Medulla
  • Tbilisi, Georgia, 0102
    • Aleksandre Aladashvili Clinic LLC
  • Tbilisi, Georgia, 0160
    • LTD MediClub Georgia
  • Tbilisi, Georgia, 0112
    • LTD Israel-Georgian Medical Research Clinic Helsicore
  • Tbilisi, Georgia, 0159
    • JSC "Vian"
• Philippines
  • Angeles, Philippines, 2009
    • Angeles University Foundation Medical Center
  • Davao City, Philippines, 8000
    • Davao Doctors Hospital
  • Lipa, Philippines, 4217
    • Lipa Medix Medical Center
  • Makati, Philippines, 1229
    • Makati Medical Center
  • Manila, Philippines, 1000
    • Manila Doctors Hospital
  • Manila, Philippines, 1000
    • ManilaMed - Medical Center
• Thailand
  • Bangkok, Thailand, 10400
    • Phramongkutklao Hospital
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital, Mahidol University
  • Bangkoknoi, Thailand, 10700
    • Siriraj Hospital
  • Khlong Luang, Thailand, 12120
    • Thammasat University Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • California
    • Covina, California, United States, 91722
      • Medvin Clinical Research
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida, Inc.
    • Coral Gables, Florida, United States, 33134
      • Herco Medical and Research Center, Inc
    • Hialeah, Florida, United States, 33012
      • Direct Helpers Research Center
    • Miami, Florida, United States, 33155
      • Allied Biomedical Research Institute
    • Miami, Florida, United States, 33173
      • Research Institute of South Florida, Inc.
    • Tampa, Florida, United States, 33606
      • Clinical Research of West Florida, Inc.
    • Winter Park, Florida, United States, 32789
      • Conquest Research, LLC
  • Georgia
    • Newnan, Georgia, United States, 30265
      • Vista Clinical Research, LLC
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Velocity Clinical Research
  • Illinois
    • Flossmoor, Illinois, United States, 60422
      • Healthcare Research Network II, LLC
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Alliance for Multispecialty Research, LLC
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center
  • 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
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Healor Primary Care/CCT Research
  • New York
    • Vestal, New York, United States, 13850
      • Meridian Clinical Research, LLC
  • North Carolina
    • Greensboro, North Carolina, United States, 27410
      • Triad Clinical Trials
  • Ohio
    • Vandalia, Ohio, United States, 45377
      • Stat Research
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center For Clinical Research
    • Philadelphia, Pennsylvania, United States, 19114
      • Tristar Clinical Investigations, P.C.
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Velocity Clinical Research Greenville
  • Texas
    • Colleyville, Texas, United States, 76034
      • PCCR Solutions
    • Houston, Texas, United States, 77099
      • Pioneer Research Solutions, Inc.
    • San Antonio, Texas, United States, 78240
      • Endeavor Clinical Trials
    • Tomball, Texas, United States, 77377
      • DM Clinical Research
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Highland Clinical Research
    • South Ogden, Utah, United States, 84405
      • South Ogden Family Medicine/CCT Research
    • 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, 23226
      • Clinical Research Partners, LLC
    • Richmond, Virginia, United States, 23219
      • Dominion Medical Associates, Inc.

Participation Criteria

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, 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) and rheumatoid arthritis

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tigulixostat 100mg; Tigulixostat 100mg, Once a day (QD) for up to 6 months	Drug: Tigulixostat; Xanthine Oxidase Inhibitor; Other Names: LC350189
Experimental: Tigulixostat 200mg; Tigulixostat 200mg, Once a day (QD) for up to 6 months	Drug: Tigulixostat; Xanthine Oxidase Inhibitor; Other Names: LC350189
Placebo Comparator: Placebo; Placebo, Once a day (QD) for up to 6 months	Drug: Placebo; Matching placebo
Experimental: Tigulixostat 300mg; Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 6 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	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	Serum uric acid (sUA) level will be measured at Month 4,5, and 6	Up to Month 6
The proportion of subjects reporting a gout flare up to each visit.	Gout flare (intense pain, swelling, or/and tenderness in the joint area) will be assessed from baseline up to 6 months	Up to Month 6
Incidence rate of adverse event	Safety assessment	Up to Month 6

Collaborators and Investigators

• Sponsor: LG Chem
• Investigators: Study Director: Hyungjin Cho, MD, LG Chem

Publications and helpful links

General Publications

• Saag KG, Dalbeth N, Hsu CY, Kuo CF, Nuki G, Perez-Ruiz F, White WB, Hariri A, Lee Y, Jang Y, Han S, Choi HK. Evaluation of the efficacy and safety of a novel xanthine oxidase inhibitor, tigulixostat, in gout patients with hyperuricemia: Design of the EURELIA 1 and EURELIA 2 studies. Contemp Clin Trials. 2025 Apr;151:107843. doi: 10.1016/j.cct.2025.107843. Epub 2025 Feb 8.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Actual): November 4, 2024
• Study Completion (Actual): December 16, 2024

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 (Estimated): October 29, 2025
• Last Update Submitted That Met QC Criteria: October 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Gout; Hyperuricemia; Xanthine Oxidase Inhibitor
• Additional Relevant MeSH Terms: Crystal Arthropathies; Musculoskeletal Diseases; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Gout; Hyperuricemia
• Other Study ID Numbers: LG-GDCL009

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