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GoutPhase 3EURELIA1NCT05586958

Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients

A Phase 3 study testing Tigulixostat in people with Gout and Hyperuricemia, run by LG Chem at 52 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Gout, Hyperuricemia, Gout Flare
What is being tested?
Tigulixostat
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
354 participants
Where
52 sitesin 4 countries
Study dates
25 Oct 2022to 16 Dec 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

52 sites in 4 countries.

52 sites in 4 countries

United States36 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765

  • PCCR Solutions

    Colleyville, Texas, 76034

  • Herco Medical and Research Center, Inc

    Coral Gables, Florida, 33134

  • Medvin Clinical Research

    Covina, California, 91722

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Healthcare Research Network II, LLC

    Flossmoor, Illinois, 60422

  • Triad Clinical Trials

    Greensboro, North Carolina, 27410

  • Velocity Clinical Research Greenville

    Greenville, South Carolina, 29615

  • HealthCare Research

    Hazelwood, Missouri, 63042

  • Direct Helpers Research Center

    Hialeah, Florida, 33012

  • Pioneer Research Solutions, Inc.

    Houston, Texas, 77099

  • Elite Clinical Research, LLC

    Jackson, Mississippi, 39202

  • Healor Primary Care/CCT Research

    Las Vegas, Nevada, 89102

  • Alliance for Multispecialty Research, LLC

    Lexington, Kentucky, 40509

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • Velocity Clinical Research

    Meridian, Idaho, 83642

  • Allied Biomedical Research Institute

    Miami, Florida, 33155

  • Research Institute of South Florida, Inc.

    Miami, Florida, 33173

  • Vista Clinical Research, LLC

    Newnan, Georgia, 30265

  • Olive Branch Family Medical Center

    Olive Branch, Mississippi, 38654

  • MD Medical Research

    Oxon Hill, Maryland, 20745

  • Tristar Clinical Investigations, P.C.

    Philadelphia, Pennsylvania, 19114

  • Practice Dr. David Headley

    Port Gibson, Mississippi, 39150

  • Meridian Clinical Research, LLC

    Portsmouth, Virginia, 23703

  • Dominion Medical Associates, Inc.

    Richmond, Virginia, 23219

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23226

  • Highland Clinical Research

    Salt Lake City, Utah, 84124

  • Endeavor Clinical Trials

    San Antonio, Texas, 78240

  • South Ogden Family Medicine/CCT Research

    South Ogden, Utah, 84405

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33606

  • DM Clinical Research

    Tomball, Texas, 77377

  • STAT Research

    Vandalia, Ohio, 45377

  • Meridian Clinical Research, LLC

    Vestal, New York, 13850

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah, 84088

  • Conquest Research, LLC

    Winter Park, Florida, 32789

Other trials in United States

Georgia6 sites

  • LTD "Clinic LJ"

    Kutaisi, 4600

  • Aleksandre Aladashvili Clinic LLC

    Tbilisi, 0102

  • LTD Israel-Georgian Medical Research Clinic Helsicore

    Tbilisi, 0112

  • JSC "Vian"

    Tbilisi, 0159

  • LTD MediClub Georgia

    Tbilisi, 0160

  • LTD Multiprofile Clinic Consilium Medulla

    Tbilisi, 0186

Other trials in Georgia

Philippines6 sites

  • Angeles University Foundation Medical Center

    Angeles, 2009

  • Davao Doctors Hospital

    Davao City, 8000

  • Lipa Medix Medical Center

    Lipa, 4217

  • Makati Medical Center

    Makati, 1229

  • Manila Doctors Hospital

    Manila, 1000

  • ManilaMed - Medical Center

    Manila, 1000

Other trials in Philippines

Thailand4 sites

  • Phramongkutklao Hospital

    Bangkok, 10400

  • Ramathibodi Hospital, Mahidol University

    Bangkok, 10400

  • Siriraj Hospital

    Bangkoknoi, 10700

  • Thammasat University Hospital

    Khlong Luang, 12120

Other trials in Thailand

About this study

Official title: 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.

Being tested
Tigulixostat, Placebo
Keywords
Gout, Hyperuricemia, Xanthine Oxidase Inhibitor
Medical subject headings
Gout, Hyperuricemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TigulixostatDrug

    Also called LC350189

    Xanthine Oxidase Inhibitor

  • PlaceboDrug

    Matching placebo

Study groups in NCT05586958
Study groupRoleWhat they receive
Tigulixostat 100mgExperimentalTigulixostat 100mg, Once a day (QD) for up to 6 months
Receives: Drug: Tigulixostat
Tigulixostat 200mgExperimentalTigulixostat 200mg, Once a day (QD) for up to 6 months
Receives: Drug: Tigulixostat
Tigulixostat 300mgExperimentalTigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 6 months
Receives: Drug: Tigulixostat
PlaceboPlacebo comparatorPlacebo, Once a day (QD) for up to 6 months
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to Month 6

Secondary outcomes (3)

  1. 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

    Measured: Up to Month 6

  2. 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

    Measured: Up to Month 6

  3. Incidence rate of adverse event

    Safety assessment

    Measured: Up to Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2022
  2. Study start25 Oct 2022
  3. Primary completion4 Nov 2024
  4. Study completion16 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
354 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05586958
Sponsor's protocol ID
LG-GDCL009
Acronym
EURELIA1
Status last verified
Oct 2025
First submitted
16 Oct 2022
Last updated
29 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 39929260

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tigulixostat in people with Gout and Hyperuricemia, run by LG Chem at 52 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Georgia, Philippines, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6 (time frame: Up to Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05586958, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.

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