A Study to Assess Efficay and Safety of LC350189 Different Doses in Gout Patients With Hyperuricemia

November 19, 2025 updated by: LG Chem

A Randomized, Multicenter, Double-blind, Double-dummy, Parallel-group, Placebo and Active Comparator-controlled, Dose Finding, and Phase II Study to Assess Efficacy and Safety of LC350189 in Gout Patients With Hyperuricemia

The aim of this 12-week randomized multicenter double-blind parallel group placebo-controlled dose finding study is to assess the efficacy and safety of three different doses of LC350189 in subjects with hyperuricemia and a diagnosis of gout.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Synexus Clinical Research
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Synexus Clinical Research
      • Mesa, Arizona, United States, 85206
        • Synexus Clinical Research
      • Tucson, Arizona, United States, 85712
        • Synexus Clinical Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Preferred Research Partner
    • Florida
      • Jupiter, Florida, United States, 33458
        • Health Awareness Inc
      • Maitland, Florida, United States, 32751
        • Meridien Research
      • Miami, Florida, United States, 33176
        • Miami Dade Medical Research Institute
      • St. Petersburg, Florida, United States, 33709
        • Meridien Research
      • Tampa, Florida, United States, 33607
        • Clinical Research Trials of Florida, Inc
      • Tampa, Florida, United States, 33613
        • Avita Clinical Trials
    • Georgia
      • Columbus, Georgia, United States, 31904
        • IACT Health
    • Illinois
      • Chicago, Illinois, United States, 60602
        • Synexus Clinical Research
    • Minnesota
      • Richfield, Minnesota, United States, 55423
        • Synexus Clinical Research
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • Olive Branch Family Medical Cente
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Synexus Clinical Research
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Quality Clinical Research
      • Omaha, Nebraska, United States, 68144
        • Synexus Clinical Research
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Synexus Clinical Research
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Onsite Clinical Solutions
      • Charlotte, North Carolina, United States, 28226
        • Onsite Clinical Solutions
    • Ohio
      • Akron, Ohio, United States, 44311
        • Synexus Clinical Research
      • Cincinnati, Ohio, United States, 45236
        • Synexus Clinical Research
      • Columbus, Ohio, United States, 43212
        • Synexus Clinical Research
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Medical Research and Consulting
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Synexus Clinical Research
    • Texas
      • Austin, Texas, United States, 78704
        • Avant Research Associates
      • Dallas, Texas, United States, 75234
        • Synexus Clinical Research
      • Houston, Texas, United States, 77450
        • Discovery MM Services Incorporated
      • San Antonio, Texas, United States, 78229
        • Synexus Clinical Research
    • Utah
      • Salt Lake City, Utah, United States, 84123
        • Synexus Clinical Research
      • West Jordan, Utah, United States, 84088
        • Advanced Clinical Research
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Dominion Medical Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects or the subject's legally acceptable representatives who sign a written informed consent form prior to the initiation of any study procedures.
  2. Subjects with hyperuricemia and a history or presence of gout per American College of Rheumatology (ACR) criteria.

Exclusion Criteria:

  1. Subjects with secondary hyperuricemia (e.g., due to myeloproliferative disorder, or organ transplant).
  2. Subjects experiencing an active acute gout attack within 3 weeks prior to screening (Visit 1).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LC350189 50mg
LC350189 50mg, Once a day (QD)
Drug: LC350189 formulated capsule
Xanthine Oxidase Inhibitor
Experimental: LC350189 100mg
LC350189 100mg, QD
Drug: LC350189 formulated capsule
Xanthine Oxidase Inhibitor
Experimental: LC350189 200mg
LC350189 200mg, QD
Drug: LC350189 formulated capsule
Xanthine Oxidase Inhibitor
Placebo Comparator: Placebo
Placebo, QD
Drug: Placebo
Matching placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With sUA (Serum Uric Acid) < 5.0 mg/dL at Day 84
Time Frame: Day 84
sUA level was measured at Day 84
Day 84

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With sUA (Serum Uric Acid) < 6.0 mg/dL at Day 84
Time Frame: Day 84
sUA level was measured at Day 84
Day 84
Maximum Percent Reduction in sUA (Serum Uric Acid) Level
Time Frame: Up to Day 84
sUA level was measured at Day 1, 14, 28, 56, and 84
Up to Day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LG Chem

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hyungjin Cho, MD, LG Chem, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 3, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 17, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LG-GDCL002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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