Phase 2
N=143
A Study to Assess Efficay and Safety of LC350189 Different Doses in Gout Patients With Hyperuricemia
Gout · Hyperuricemia
Bottom Line
View on ClinicalTrials.gov: NCT03934099 ↗Enrolled (actual)
143
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Percentage of Participants With sUA (Serum Uric Acid) < 5.0 mg/dL at Day 84 — 47.1; 44.7; 62.2; 2.9 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LC350189 formulated capsule (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- LG Chem
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With sUA (Serum Uric Acid) < 5.0 mg/dL at Day 84 |
47.1; 44.7; 62.2; 2.9 | — |
| SECONDARY Percentage of Participants With sUA (Serum Uric Acid) < 6.0 mg/dL at Day 84 |
58.8; 63.2; 78.4; 2.9 | — |
| SECONDARY Maximum Percent Reduction in sUA (Serum Uric Acid) Level |
-46.67; -50.64; -66.79; -11.20 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT03934099). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.