GoutPhase 2NCT03934099
A Study to Assess Efficay and Safety of LC350189 Different Doses in Gout Patients With Hyperuricemia
A Phase 2 study testing LC350189 formulated capsule in people with Gout and Hyperuricemia, run by LG Chem at 34 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gout, Hyperuricemia
- What is being tested?
- LC350189 formulated capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 34 sitesUnited States
- Study dates
- 2 Dec 2019to 17 May 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Synexus Clinical Research
Akron, Ohio, 44311
Synexus Clinical Research
Anderson, South Carolina, 29621
Avant Research Associates
Austin, Texas, 78704
Synexus Clinical Research
Birmingham, Alabama, 35211
Synexus Clinical Research
Chandler, Arizona, 85224
OnSite Clinical Solutions
Charlotte, North Carolina, 28226
OnSite Clinical Solutions
Charlotte, North Carolina, 28277
Synexus Clinical Research
Chicago, Illinois, 60602
Synexus Clinical Research
Cincinnati, Ohio, 45236
IACT Health
Columbus, Georgia, 31904
Synexus Clinical Research
Columbus, Ohio, 43212
Synexus Clinical Research
Dallas, Texas, 75234
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635
Synexus Clinical Research
Henderson, Nevada, 89052
Discovery MM Services Incorporated
Houston, Texas, 77450
Health Awareness Inc
Jupiter, Florida, 33458
Preferred Research Partner
Little Rock, Arkansas, 72211
Meridien Research
Maitland, Florida, 32751
Synexus Clinical Research
Mesa, Arizona, 85206
Miami Dade Medical Research Institute
Miami, Florida, 33176
Paramount Medical Research and Consulting
Middleburg Heights, Ohio, 44130
Olive Branch Family Medical Cente
Olive Branch, Mississippi, 38654
Quality Clinical Research
Omaha, Nebraska, 68114
Synexus Clinical Research
Omaha, Nebraska, 68144
Synexus Clinical Research
Richfield, Minnesota, 55423
Dominion Medical Associates
Richmond, Virginia, 23219
Synexus Clinical Research
Salt Lake City, Utah, 84123
Synexus Clinical Research
San Antonio, Texas, 78229
Synexus Clinical Research
St Louis, Missouri, 63141
Meridien Research
St. Petersburg, Florida, 33709
Clinical Research Trials of Florida, Inc
Tampa, Florida, 33607
Avita Clinical Trials
Tampa, Florida, 33613
Synexus Clinical Research
Tucson, Arizona, 85712
Advanced Clinical Research
West Jordan, Utah, 84088
About this study
Official title: 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.
- Conditions
- Gout, Hyperuricemia
- Being tested
- LC350189 formulated capsule, Placebo
- Medical subject headings
- Gout, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC350189 formulated capsuleDrug
Xanthine Oxidase Inhibitor
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| LC350189 50mg | Experimental | LC350189 50mg, Once a day (QD) Receives: Drug: LC350189 formulated capsule |
| LC350189 100mg | Experimental | LC350189 100mg, QD Receives: Drug: LC350189 formulated capsule |
| LC350189 200mg | Experimental | LC350189 200mg, QD Receives: Drug: LC350189 formulated capsule |
| Placebo | Placebo comparator | Placebo, QD Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With sUA (Serum Uric Acid) < 5.0 mg/dL at Day 84
sUA level was measured at Day 84
Measured: Day 84
Secondary outcomes (2)
Percentage of Participants With sUA (Serum Uric Acid) < 6.0 mg/dL at Day 84
sUA level was measured at Day 84
Measured: Day 84
Maximum Percent Reduction in sUA (Serum Uric Acid) Level
sUA level was measured at Day 1, 14, 28, 56, and 84
Measured: Up to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start2 Dec 2019
- Primary completion3 May 2021
- Study completion17 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyungjin Cho, MD, Study director, LG Chem, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934099
- Sponsor's protocol ID
- LG-GDCL002
- Status last verified
- Nov 2025
- First submitted
- 25 Apr 2019
- Last updated
- 3 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03934099
- Acronym / sponsor ID
- LG-GDCL002
- Conditions
- Gout, Hyperuricemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 17 May 2021 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Posted 3 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LC350189 50mg | Experimental | Drug: LC350189 formulated capsuleLC350189 50mg, Once a day (QD) |
| LC350189 100mg | Experimental | Drug: LC350189 formulated capsuleLC350189 100mg, QD |
| LC350189 200mg | Experimental | Drug: LC350189 formulated capsuleLC350189 200mg, QD |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, QD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LC350189 formulated capsuleXanthine Oxidase Inhibitor | Drug | LC350189 100mg, LC350189 200mg, LC350189 50mg |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
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
2 secondary outcomes
Percentage of Participants With sUA (Serum Uric Acid) < 6.0 mg/dL at Day 84
Time frame: Day 84
Maximum Percent Reduction in sUA (Serum Uric Acid) Level
Time frame: Up to Day 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Gout
RecruitingPhase 4
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Participants With Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Tophaceous Gout
Not yet recruitingPhase 3
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout
Gout Disease
Enrolling by invitation
The Remote Monitoring of Gout Study
Gout Initiating Urate-loweringUrate-lowering Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyungjin Cho, MD study director
LG Chem, Ltd.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LC350189 formulated capsule in people with Gout and Hyperuricemia, run by LG Chem at 34 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With sUA (Serum Uric Acid) < 5.0 mg/dL at Day 84 (time frame: Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.