Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified September 2025 by LG Chem
Sponsor
LG Chem
Information Provided by (Responsible Party)
LG Chem
Clinicaltrials.gov Identifier
NCT05586958
Other Study ID Numbers:
LG-GDCL009
First Submitted
October 15, 2022
First Posted
October 18, 2022
Last Update Posted
October 28, 2025
Last Verified
September 2025

ClinicalTrials.gov processed this data on October 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
GoutHyperuricemiaGout FlareTophi
Drug: TigulixostatDrug: TigulixostatDrug: TigulixostatDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment354 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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
Study Start DateOctober 24, 2022
Actual Primary Completion DateNovember 3, 2024
Actual Study Completion DateDecember 15, 2024

Groups and Cohorts

Group/CohortIntervention/Treatment
Tigulixostat 100mg
Tigulixostat 100mg, Once a day (QD) for up to 6 months
Drug: Tigulixostat
Xanthine Oxidase Inhibitor
Tigulixostat 200mg
Tigulixostat 200mg, Once a day (QD) for up to 6 months
Drug: Tigulixostat
Xanthine Oxidase Inhibitor
Tigulixostat 300mg
Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 6 months
Drug: Tigulixostat
Xanthine Oxidase Inhibitor
Placebo
Placebo, Once a day (QD) for up to 6 months
Drug: Placebo
Matching placebo

Outcome Measures

Primary Outcome Measures
  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
Secondary Outcome Measures
  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
  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
  3. Incidence rate of adverse event
    Safety assessment

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsLG Chem
Locations
University of Alabama at Birmingham | Birmingham Alabama, United States, 35233Medvin Clinical Research | Covina California, United States, 91722Clinical Research of West Florida, Inc. | Clearwater Florida, United States, 33765Herco Medical and Research Center, Inc | Coral Gables Florida, United States, 33134Direct Helpers Research Center | Hialeah Florida, United States, 33012Allied Biomedical Research Institute | Miami Florida, United States, 33155Research Institute of South Florida, Inc. | Miami Florida, United States, 33173Clinical Research of West Florida, Inc. | Tampa Florida, United States, 33606Conquest Research, LLC | Winter Park Florida, United States, 32789Vista Clinical Research, LLC | Newnan Georgia, United States, 30265Velocity Clinical Research | Meridian Idaho, United States, 83642Healthcare Research Network II, LLC | Flossmoor Illinois, United States, 60422Alliance for Multispecialty Research, LLC | Lexington Kentucky, United States, 40509L-MARC Research Center | Louisville Kentucky, United States, 40213MD Medical Research | Oxon Hill Maryland, United States, 20745Elite Clinical Research, LLC | Jackson Mississippi, United States, 39202Olive Branch Family Medical Center | Olive Branch Mississippi, United States, 38654Practice Dr. David Headley | Port Gibson Mississippi, United States, 39150HealthCare Research | Hazelwood Missouri, United States, 63042Healor Primary Care/CCT Research | Las Vegas Nevada, United States, 89102Meridian Clinical Research, LLC | Vestal New York, United States, 13850Triad Clinical Trials | Greensboro North Carolina, United States, 27410STAT Research | Vandalia Ohio, United States, 45377Altoona Center for Clinical Research | Duncansville Pennsylvania, United States, 16635Tristar Clinical Investigations, P.C. | Philadelphia Pennsylvania, United States, 19114Velocity Clinical Research Greenville | Greenville South Carolina, United States, 29615PCCR Solutions | Colleyville Texas, United States, 76034Pioneer Research Solutions, Inc. | Houston Texas, United States, 77099Endeavor Clinical Trials | San Antonio Texas, United States, 78240DM Clinical Research | Tomball Texas, United States, 77377Highland Clinical Research | Salt Lake City Utah, United States, 84124South Ogden Family Medicine/CCT Research | South Ogden Utah, United States, 84405Velocity Clinical Research, Salt Lake City | West Jordan Utah, United States, 84088Meridian Clinical Research, LLC | Portsmouth Virginia, United States, 23703Dominion Medical Associates, Inc. | Richmond Virginia, United States, 23219Clinical Research Partners, LLC | Richmond Virginia, United States, 23226LTD "Clinic LJ" | Kutaisi , Georgia, 4600Aleksandre Aladashvili Clinic LLC | Tbilisi , Georgia, 0102LTD Israel-Georgian Medical Research Clinic Helsicore | Tbilisi , Georgia, 0112JSC "Vian" | Tbilisi , Georgia, 0159LTD MediClub Georgia | Tbilisi , Georgia, 0160LTD Multiprofile Clinic Consilium Medulla | Tbilisi , Georgia, 0186Angeles University Foundation Medical Center | Angeles , Philippines, 2009Davao Doctors Hospital | Davao City , Philippines, 8000Lipa Medix Medical Center | Lipa , Philippines, 4217Makati Medical Center | Makati , Philippines, 1229Manila Doctors Hospital | Manila , Philippines, 1000ManilaMed - Medical Center | Manila , Philippines, 1000Phramongkutklao Hospital | Bangkok , Thailand, 10400Ramathibodi Hospital, Mahidol University | Bangkok , Thailand, 10400Siriraj Hospital | Bangkoknoi , Thailand, 10700Thammasat University Hospital | Khlong Luang , Thailand, 12120
Investigators
Study Director: Hyungjin Cho, MD, LG Chem