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Study on the Effects of Tigulixostat and Allopurinol in Patients with Gout and High Uric Acid Levels

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the condition known as gout, which is often associated with high levels of uric acid in the blood, a condition called hyperuricemia. The study aims to evaluate the effectiveness and safety of a new treatment called Tigulixostat in comparison to an existing medication, Allopurinol. Tigulixostat is being tested in tablet form, and its effects will be compared to those of Allopurinol, which is also administered in capsule form. Additionally, some participants will receive a placebo to help assess the true effects of the medications being studied.

The purpose of this study is to determine how well Tigulixostat works in reducing uric acid levels in patients with gout and hyperuricemia. Participants will be randomly assigned to receive either Tigulixostat, Allopurinol, or a placebo. The study will last for several months, during which participants will have regular check-ups to monitor their uric acid levels and overall health. The goal is to see if Tigulixostat can help achieve and maintain lower uric acid levels over time, specifically aiming for levels below 6 mg/dL at certain points during the study.

Throughout the study, participants will be observed for any potential side effects or adverse reactions to the medications. The study will also track the occurrence of gout flares, which are sudden and severe attacks of pain and swelling in the joints, and the resolution of any existing tophi, which are lumps formed by uric acid crystals. The safety of the treatments will be closely monitored through various health assessments, including physical exams and laboratory tests. The study is expected to provide valuable information on the potential benefits and risks of Tigulixostat for patients with gout and hyperuricemia.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and randomization

    After joining the study you will be assigned to one of two groups in a double‑blind manner. one group receives tigulixostat 300 mg taken by mouth once daily and matching placebo capsules, the other group receives allopurinol 800 mg taken by mouth once daily and matching placebo tablets. the assignment is performed by the study staff using a computer‑generated randomization list.

  2. Step 2

    Start of background medication

    In addition to the study drug you will take background medicines. colchicine 1.8 mg is taken by mouth once daily to help prevent gout attacks. naproxen 1000 mg is taken by mouth once daily to manage pain and inflammation. these medicines are given to all participants regardless of the group you are in.

  3. Step 3

    Daily study medication intake

    Each day you will swallow the assigned study tablet or capsule with water. the dosing schedule is once daily, every day, for the entire study period of twelve months. the matching placebo is taken in the same way as the active drug to keep the study blind.

  4. Step 4

    Monthly safety checks

    Throughout the study you will attend regular clinic visits for safety monitoring. at each visit blood samples are taken to measure sua (serum uric acid) levels, vital signs are recorded, and you will be asked about any adverse events such as nausea, skin reactions, or kidney problems. these visits occur approximately once each month.

  5. Step 5

    Primary efficacy assessment

    At the end of month 4, month 5, and month 6 a blood test is performed to determine whether your sua level is below 6.0 mg/dL. the primary goal of the study is to have this level sustained at each of these three time points.

  6. Step 6

    Secondary efficacy assessment – gout flare monitoring

    From month 6 through month 12 you will keep a diary of any gout attacks (known as gout flares). the study staff will review the diary entries at the month 12 visit to calculate the proportion of participants who experienced at least one flare during this period.

  7. Step 7

    Secondary efficacy assessment – tophus evaluation

    At month 12 a physical examination is performed to assess the status of any existing tophus (deposits of uric acid crystals under the skin). the evaluation looks for complete resolution of at least one target tophus, no new tophi, and no progression of existing ones.

  8. Step 8

    Final visit and study completion

    After the month 12 assessments you will have a final study visit. the visit includes a summary of safety findings, a review of all adverse events, and instructions for stopping the study medication. study participation ends after this visit.

Who can join the trial?

6 criteria

  • You must be willing and able to sign a written informed consent form before any study activities begin.
  • You need to be between 18 and 85 years old, inclusive.
  • You must have hyperuricemia (high uric‑acid level in the blood) and a history or current presence of gout as defined by standard medical criteria.
  • If you are already taking a medication that lowers uric acid (called urate‑lowering therapy), your blood test must show a serum uric acid (sUA) level of at least 6.0 mg/dL at the first screening visit; if you are not on such medication, your sUA must be at least 7.0 mg/dL. Those on medication will need to stop it for a short period (washout) and must still have an sUA of ≥ 7.0 mg/dL at a later visit before randomization.
  • Your body mass index (BMI), a measure of weight relative to height, must be 50 kg/m² or less at screening.
  • Your kidney function, measured by estimated glomerular filtration rate (eGFR), must be at least 30 mL/min/1.73 m² at screening.

Who cannot join the trial?

6 criteria

  • If your high uric acid level (hyperuricemia) is caused by another disease or condition—such as a blood‑cell disorder, kidney failure, kidney tube problems, lead poisoning, certain skin diseases, or rare genetic enzyme problems—you cannot take part.
  • If you have had a sudden, painful gout flare (an acute gout attack) within the two weeks before the first study visit, you are not eligible.
  • If you are of Asian descent (for example, Han Chinese, Korean, Thai) or Black/African descent (for example, African American) and a genetic test shows you have HLA B*58:01, you cannot join the trial.
  • If you have previously received a medication called uricase (such as pegloticase), you are excluded.
  • If you have not been taking a steady, unchanged dose of any medicines that can affect uric acid levels—such as losartan (blood‑pressure medicine), fibrates (cholesterol medicine), thiazide or loop diuretics (water pills), or aspirin (ASA)—for at least three weeks before screening, you cannot participate. Using aspirin at doses higher than 325 mg per day is also not allowed.
  • If you have a past diagnosis of xanthinuria, a rare condition that prevents the body from breaking down certain substances, you are not eligible.
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Investigated drugs

  • Allopurinol

    is a medication taken by mouth that helps lower the amount of uric acid in the blood. In this study it is used as the standard treatment to compare the new drug against. By reducing uric acid, it aims to prevent gout attacks and long‑term joint damage.

  • Colchicine

    is a medicine taken by mouth that is commonly used to prevent or treat sudden gout flare‑ups. In the trial it is given to all participants as background therapy to help control acute inflammation that can occur during the study.

  • Naproxen

    is an over‑the‑counter pain reliever taken by mouth that belongs to the class of non‑steroidal anti‑inflammatory drugs (NSAIDs). In this trial it is provided as background therapy to relieve pain and reduce inflammation associated with gout attacks.

  • Tigulixostat

    is the experimental drug being tested in the study. It is taken by mouth and is designed to lower blood uric acid levels, with the goal of keeping them below the target level. The trial evaluates whether tigulixostat works as well as, or better than, the standard treatment (allopurinol) in controlling gout and hyperuricemia.

What is already known about the treatment

  • Allopurinol

    This medication comes as oral capsules that are swallowed whole. It is an established drug that has been used for many years to treat gout and high uric acid levels. Allopurinol works by blocking an enzyme called xanthine oxidase, which reduces the amount of uric acid made by the body. It belongs to the class of xanthine oxidase inhibitors, also known as uric‑acid‑lowering agents.

  • Colchicine

    Colchicine is taken by mouth, usually as a tablet or liquid that is swallowed. It is a long‑approved treatment for gout attacks and some other rare disorders. The drug reduces inflammation by stopping certain white blood cells from moving to the joint area where pain occurs. It is classified as an anti‑inflammatory agent that works on microtubules.

  • Naproxen

    Naproxen is provided as oral tablets that are swallowed with water. It is a widely used, over‑the‑counter medicine for pain and swelling in conditions like gout. Naproxen eases symptoms by blocking COX enzymes, which lowers the production of pain‑causing chemicals called prostaglandins. It belongs to the non‑steroidal anti‑inflammatory drug (NSAID) class.

  • Tigulixostat

    Tigulixostat is given as oral tablets that are taken by swallowing. It is currently being studied in phase 3 clinical trials for gout patients with high uric acid and is not yet widely available. The drug appears to lower uric acid by preventing its re‑absorption in the kidneys, helping the body get rid of excess acid. It is considered an experimental uric‑acid‑reabsorption inhibitor.

Investigated diseases

Gout with hyperuricemia - Gout is a condition where excess uric acid in the blood forms tiny crystals that settle in joints, causing swelling, warmth, and sharp pain. The first attacks often affect the big toe but can move to other joints over time. Repeated episodes may lead to larger crystal deposits called tophi, which can appear under the skin. As the condition progresses, attacks may become more frequent and last longer. Joint damage can develop gradually if the crystal buildup continues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501421-20-00Protocol codeLG-GDCL010Estimated enrolment5 052 patientsSponsorLG Chem Ltd.

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