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New gout pill shows promise in lowering uric acid levels

NCT ID NCT05586958

Disease control Sponsor: LG Chem Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new medicine called tigulixostat in 354 adults with gout and high uric acid. Participants took one of three doses or a placebo for 6 months. The main goal was to see if the drug could keep uric acid below a target level. The trial is complete and results will show how well the drug works and if it is safe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

354 people

The number who actually took part.

Started

Oct 2022

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

gout Hyperuricemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gout Gout flare Hyperuricemia TOPHI

Contacts and locations

Locations

  • Aleksandre Aladashvili Clinic LLC

    Tbilisi, 0102, Georgia

  • Alliance for Multispecialty Research, LLC

    Lexington, Kentucky, 40509, United States

  • Allied Biomedical Research Institute

    Miami, Florida, 33155, United States

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635, United States

  • Angeles University Foundation Medical Center

    Angeles, 2009, Philippines

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23226, United States

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765, United States

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33606, United States

  • Conquest Research, LLC

    Winter Park, Florida, 32789, United States

  • DM Clinical Research

    Tomball, Texas, 77377, United States

  • Davao Doctors Hospital

    Davao City, 8000, Philippines

  • Direct Helpers Research Center

    Hialeah, Florida, 33012, United States

  • Dominion Medical Associates, Inc.

    Richmond, Virginia, 23219, United States

  • Elite Clinical Research, LLC

    Jackson, Mississippi, 39202, United States

  • Endeavor Clinical Trials

    San Antonio, Texas, 78240, United States

  • Healor Primary Care/CCT Research

    Las Vegas, Nevada, 89102, United States

  • HealthCare Research

    Hazelwood, Missouri, 63042, United States

  • Healthcare Research Network II, LLC

    Flossmoor, Illinois, 60422, United States

  • Herco Medical and Research Center, Inc

    Coral Gables, Florida, 33134, United States

  • Highland Clinical Research

    Salt Lake City, Utah, 84124, United States

  • JSC "Vian"

    Tbilisi, 0159, Georgia

  • L-MARC Research Center

    Louisville, Kentucky, 40213, United States

  • LTD "Clinic LJ"

    Kutaisi, 4600, Georgia

  • LTD Israel-Georgian Medical Research Clinic Helsicore

    Tbilisi, 0112, Georgia

  • LTD MediClub Georgia

    Tbilisi, 0160, Georgia

  • LTD Multiprofile Clinic Consilium Medulla

    Tbilisi, 0186, Georgia

  • Lipa Medix Medical Center

    Lipa, 4217, Philippines

  • MD Medical Research

    Oxon Hill, Maryland, 20745, United States

  • Makati Medical Center

    Makati, 1229, Philippines

  • Manila Doctors Hospital

    Manila, 1000, Philippines

  • ManilaMed - Medical Center

    Manila, 1000, Philippines

  • Medvin Clinical Research

    Covina, California, 91722, United States

  • Meridian Clinical Research, LLC

    Vestal, New York, 13850, United States

  • Meridian Clinical Research, LLC

    Portsmouth, Virginia, 23703, United States

  • Olive Branch Family Medical Center

    Olive Branch, Mississippi, 38654, United States

  • PCCR Solutions

    Colleyville, Texas, 76034, United States

  • Phramongkutklao Hospital

    Bangkok, 10400, Thailand

  • Pioneer Research Solutions, Inc.

    Houston, Texas, 77099, United States

  • Practice Dr. David Headley

    Port Gibson, Mississippi, 39150, United States

  • Ramathibodi Hospital, Mahidol University

    Bangkok, 10400, Thailand

  • Research Institute of South Florida, Inc.

    Miami, Florida, 33173, United States

  • STAT Research

    Vandalia, Ohio, 45377, United States

  • Siriraj Hospital

    Bangkoknoi, 10700, Thailand

  • South Ogden Family Medicine/CCT Research

    South Ogden, Utah, 84405, United States

  • Thammasat University Hospital

    Khlong Luang, 12120, Thailand

  • Triad Clinical Trials

    Greensboro, North Carolina, 27410, United States

  • Tristar Clinical Investigations, P.C.

    Philadelphia, Pennsylvania, 19114, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • Velocity Clinical Research

    Meridian, Idaho, 83642, United States

  • Velocity Clinical Research Greenville

    Greenville, South Carolina, 29615, United States

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah, 84088, United States

  • Vista Clinical Research, LLC

    Newnan, Georgia, 30265, United States

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