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

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: Completed
• Conditions: Hyperuricemia; Gout
• Intervention / Treatment: Drug: Placebo; Drug: LC350189 formulated capsule

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With sUA (Serum Uric Acid) < 5.0 mg/dL at Day 84	sUA level was measured at Day 84	Day 84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With sUA (Serum Uric Acid) < 6.0 mg/dL at Day 84	sUA level was measured at Day 84	Day 84
Maximum Percent Reduction in sUA (Serum Uric Acid) Level	sUA level was measured at Day 1, 14, 28, 56, and 84	Up to Day 84

Collaborators and Investigators

• Sponsor: LG Chem
• Investigators: Study Director: Hyungjin Cho, MD, LG Chem, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2019
• Primary Completion (Actual): May 3, 2021
• Study Completion (Actual): May 17, 2021

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Crystal Arthropathies; Musculoskeletal Diseases; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Gout; Hyperuricemia
• Other Study ID 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