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Evaluating Tigulixostat for treating gout patients

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

Phase 3 Interventional LG Chem · NCT05586958

This study is testing whether different doses of a new drug called Tigulixostat can help people with gout lower their uric acid levels and reduce flare-ups.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment350 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorLG Chem Industry-sponsored
Locations37 sites (Birmingham, Alabama and 36 other locations)
Trial IDNCT05586958 on ClinicalTrials.gov

What this trial studies

This phase 3 clinical trial is a 6-month randomized, multi-regional, double-blind, parallel group study designed to assess the efficacy and safety of three different doses of Tigulixostat in patients suffering from gout and hyperuricemia. Participants will be randomly assigned to receive either Tigulixostat or a placebo, with the aim of determining the drug's effectiveness in lowering serum uric acid levels and reducing gout flare-ups. The study will include patients aged 18 to 85 who meet specific criteria related to their uric acid levels and gout history.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 85 with hyperuricemia and a history of gout who are either on or off urate-lowering therapies.

Not a fit: Patients experiencing acute gout attacks or those with secondary hyperuricemia may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of gout and reduce the frequency of painful flare-ups for patients.

How similar studies have performed: Previous studies have shown promise with similar xanthine oxidase inhibitors, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions GoutHyperuricemiaGout FlareTophiXanthine Oxidase Inhibitor
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.