Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients

NCT05586958 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: LG-GDCL009
• Study Type: interventional
• Target: 354
• Locations: 4 countries
• Sites: 52

Brief 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.

Conditions

Gout; Hyperuricemia; Gout Flare; Tophi

Keywords

Gout; Hyperuricemia; Xanthine Oxidase Inhibitor

Outcome Measures

Primary Outcomes (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

  Up to Month 6

Secondary Outcomes (3)

• The proportion of subjects with sUA levels <5.0 mg/dL sustained at months 4, 5, and 6

  Up to Month 6

• The proportion of subjects reporting a gout flare up to each visit.

  Up to Month 6

• Incidence rate of adverse event

  Up to Month 6

Study Arms (4)

Tigulixostat 100mg

EXPERIMENTAL

Tigulixostat 100mg, Once a day (QD) for up to 6 months

Drug: Tigulixostat

Tigulixostat 200mg

EXPERIMENTAL

Tigulixostat 200mg, Once a day (QD) for up to 6 months

Drug: Tigulixostat

Tigulixostat 300mg

EXPERIMENTAL

Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 6 months

Drug: Tigulixostat

Placebo

PLACEBO COMPARATOR

Placebo, Once a day (QD) for up to 6 months

Drug: Placebo

Interventions

Tigulixostat DRUG

Xanthine Oxidase Inhibitor

Also known as: LC350189

Tigulixostat 100mg; Tigulixostat 200mg; Tigulixostat 300mg

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Chem: lead

Study Sites (52)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Medvin Clinical Research

Covina, California, 91722, United States

Location

Clinical Research of West Florida, Inc.

Clearwater, Florida, 33765, United States

Location

Herco Medical and Research Center, Inc

Coral Gables, Florida, 33134, United States

Location

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

Location

Allied Biomedical Research Institute

Miami, Florida, 33155, United States

Location

Research Institute of South Florida, Inc.

Miami, Florida, 33173, United States

Location

Clinical Research of West Florida, Inc.

Tampa, Florida, 33606, United States

Location

Conquest Research, LLC

Winter Park, Florida, 32789, United States

Location

Vista Clinical Research, LLC

Newnan, Georgia, 30265, United States

Location

Velocity Clinical Research

Meridian, Idaho, 83642, United States

Location

Healthcare Research Network II, LLC

Flossmoor, Illinois, 60422, United States

Location

Alliance for Multispecialty Research, LLC

Lexington, Kentucky, 40509, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

MD Medical Research

Oxon Hill, Maryland, 20745, United States

Location

Elite Clinical Research, LLC

Jackson, Mississippi, 39202, United States

Location

Olive Branch Family Medical Center

Olive Branch, Mississippi, 38654, United States

Location

Practice Dr. David Headley

Port Gibson, Mississippi, 39150, United States

Location

HealthCare Research

Hazelwood, Missouri, 63042, United States

Location

Healor Primary Care/CCT Research

Las Vegas, Nevada, 89102, United States

Location

Meridian Clinical Research, LLC

Vestal, New York, 13850, United States

Location

Triad Clinical Trials

Greensboro, North Carolina, 27410, United States

Location

STAT Research

Vandalia, Ohio, 45377, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Tristar Clinical Investigations, P.C.

Philadelphia, Pennsylvania, 19114, United States

Location

Velocity Clinical Research Greenville

Greenville, South Carolina, 29615, United States

Location

PCCR Solutions

Colleyville, Texas, 76034, United States

Location

Pioneer Research Solutions, Inc.

Houston, Texas, 77099, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78240, United States

Location

DM Clinical Research

Tomball, Texas, 77377, United States

Location

Highland Clinical Research

Salt Lake City, Utah, 84124, United States

Location

South Ogden Family Medicine/CCT Research

South Ogden, Utah, 84405, United States

Location

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088, United States

Location

Meridian Clinical Research, LLC

Portsmouth, Virginia, 23703, United States

Location

Dominion Medical Associates, Inc.

Richmond, Virginia, 23219, United States

Location

Clinical Research Partners, LLC

Richmond, Virginia, 23226, United States

Location

LTD "Clinic LJ"

Kutaisi, 4600, Georgia

Location

Aleksandre Aladashvili Clinic LLC

Tbilisi, 0102, Georgia

Location

LTD Israel-Georgian Medical Research Clinic Helsicore

Tbilisi, 0112, Georgia

Location

JSC "Vian"

Tbilisi, 0159, Georgia

Location

LTD MediClub Georgia

Tbilisi, 0160, Georgia

Location

LTD Multiprofile Clinic Consilium Medulla

Tbilisi, 0186, Georgia

Location

Angeles University Foundation Medical Center

Angeles, 2009, Philippines

Location

Davao Doctors Hospital

Davao City, 8000, Philippines

Location

Lipa Medix Medical Center

Lipa, 4217, Philippines

Location

Makati Medical Center

Makati, 1229, Philippines

Location

Manila Doctors Hospital

Manila, 1000, Philippines

Location

ManilaMed - Medical Center

Manila, 1000, Philippines

Location

Phramongkutklao Hospital

Bangkok, 10400, Thailand

Location

Ramathibodi Hospital, Mahidol University

Bangkok, 10400, Thailand

Location

Siriraj Hospital

Bangkoknoi, 10700, Thailand

Location

Thammasat University Hospital

Khlong Luang, 12120, Thailand

Location

Related Publications (1)

• 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.

  PMID: 39929260 DERIVED

MeSH Terms

Conditions

Gout; Hyperuricemia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hyungjin Cho, MD

  LG Chem

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: October 19, 2022
• Study Start: October 25, 2022
• Primary Completion: November 4, 2024
• Study Completion: December 16, 2024
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

GE (6); TH (4); US (36); PH (6)