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
1 other identifier
interventional
156
1 country
34
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2019
Shorter than P25 for phase_2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2019
CompletedFirst Posted
Study publicly available on registry
May 1, 2019
CompletedStudy Start
First participant enrolled
December 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2021
CompletedResults Posted
Study results publicly available
December 3, 2025
CompletedDecember 3, 2025
November 1, 2025
1.4 years
April 25, 2019
October 29, 2025
November 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Percentage of Participants With sUA (Serum Uric Acid) < 6.0 mg/dL at Day 84
Day 84
Maximum Percent Reduction in sUA (Serum Uric Acid) Level
Up to Day 84
Study Arms (4)
LC350189 50mg
EXPERIMENTALLC350189 50mg, Once a day (QD)
LC350189 100mg
EXPERIMENTALLC350189 100mg, QD
LC350189 200mg
EXPERIMENTALLC350189 200mg, QD
Placebo
PLACEBO COMPARATORPlacebo, QD
Interventions
Eligibility Criteria
You may qualify if:
- Subjects or the subject's legally acceptable representatives who sign a written informed consent form prior to the initiation of any study procedures.
- Subjects with hyperuricemia and a history or presence of gout per American College of Rheumatology (ACR) criteria.
You may not qualify if:
- Subjects with secondary hyperuricemia (e.g., due to myeloproliferative disorder, or organ transplant).
- Subjects experiencing an active acute gout attack within 3 weeks prior to screening (Visit 1).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LG Chemlead
Study Sites (34)
Synexus Clinical Research
Birmingham, Alabama, 35211, United States
Synexus Clinical Research
Chandler, Arizona, 85224, United States
Synexus Clinical Research
Mesa, Arizona, 85206, United States
Synexus Clinical Research
Tucson, Arizona, 85712, United States
Preferred Research Partner
Little Rock, Arkansas, 72211, United States
Health Awareness Inc
Jupiter, Florida, 33458, United States
Meridien Research
Maitland, Florida, 32751, United States
Miami Dade Medical Research Institute
Miami, Florida, 33176, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Clinical Research Trials of Florida, Inc
Tampa, Florida, 33607, United States
Avita Clinical Trials
Tampa, Florida, 33613, United States
IACT Health
Columbus, Georgia, 31904, United States
Synexus Clinical Research
Chicago, Illinois, 60602, United States
Synexus Clinical Research
Richfield, Minnesota, 55423, United States
Olive Branch Family Medical Cente
Olive Branch, Mississippi, 38654, United States
Synexus Clinical Research
St Louis, Missouri, 63141, United States
Quality Clinical Research
Omaha, Nebraska, 68114, United States
Synexus Clinical Research
Omaha, Nebraska, 68144, United States
Synexus Clinical Research
Henderson, Nevada, 89052, United States
OnSite Clinical Solutions
Charlotte, North Carolina, 28226, United States
OnSite Clinical Solutions
Charlotte, North Carolina, 28277, United States
Synexus Clinical Research
Akron, Ohio, 44311, United States
Synexus Clinical Research
Cincinnati, Ohio, 45236, United States
Synexus Clinical Research
Columbus, Ohio, 43212, United States
Paramount Medical Research and Consulting
Middleburg Heights, Ohio, 44130, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
Synexus Clinical Research
Anderson, South Carolina, 29621, United States
Avant Research Associates
Austin, Texas, 78704, United States
Synexus Clinical Research
Dallas, Texas, 75234, United States
Discovery MM Services Incorporated
Houston, Texas, 77450, United States
Synexus Clinical Research
San Antonio, Texas, 78229, United States
Synexus Clinical Research
Salt Lake City, Utah, 84123, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
Dominion Medical Associates
Richmond, Virginia, 23219, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Younghwan Jang
- Organization
- LG Chem
Study Officials
- STUDY DIRECTOR
Hyungjin Cho, MD
LG Chem, Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2019
First Posted
May 1, 2019
Study Start
December 2, 2019
Primary Completion
May 3, 2021
Study Completion
May 17, 2021
Last Updated
December 3, 2025
Results First Posted
December 3, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share