Trial Outcomes & Findings for A Study to Assess Efficay and Safety of LC350189 Different Doses in Gout Patients With Hyperuricemia (NCT NCT03934099)
NCT ID: NCT03934099
Last Updated: 2025-12-03
Results Overview
sUA level was measured at Day 84
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
156 participants
Primary outcome timeframe
Day 84
Results posted on
2025-12-03
Participant Flow
Of the 156 participants enrolled, 13 were initially assigned to an active control group (Febuxostat) under the original protocol. This group was removed following a protocol amendment. Final results are reported based on the amended protocol, which excluded the active control group. Therefore, the discrepancy between the total number randomized and the final reported number reflects this change.
Participant milestones
| Measure |
LC350189 50mg
LC350189 50mg, Once a day (QD)
LC350189 formulated capsule: Xanthine Oxidase Inhibitor
|
LC350189 100mg
LC350189 100mg, QD
LC350189 formulated capsule: Xanthine Oxidase Inhibitor
|
LC350189 200mg
LC350189 200mg, QD
LC350189 formulated capsule: Xanthine Oxidase Inhibitor
|
Placebo
Placebo, QD
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
38
|
37
|
34
|
|
Overall Study
COMPLETED
|
30
|
32
|
34
|
32
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
3
|
2
|
Reasons for withdrawal
| Measure |
LC350189 50mg
LC350189 50mg, Once a day (QD)
LC350189 formulated capsule: Xanthine Oxidase Inhibitor
|
LC350189 100mg
LC350189 100mg, QD
LC350189 formulated capsule: Xanthine Oxidase Inhibitor
|
LC350189 200mg
LC350189 200mg, QD
LC350189 formulated capsule: Xanthine Oxidase Inhibitor
|
Placebo
Placebo, QD
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
1
|
1
|
|
Overall Study
Other reasons
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Assess Efficay and Safety of LC350189 Different Doses in Gout Patients With Hyperuricemia
Baseline characteristics by cohort
| Measure |
LC350189 50mg
n=34 Participants
LC350189 50mg, Once a day (QD)
LC350189 formulated capsule: Xanthine Oxidase Inhibitor
|
LC350189 100mg
n=38 Participants
LC350189 100mg, QD
LC350189 formulated capsule: Xanthine Oxidase Inhibitor
|
LC350189 200mg
n=37 Participants
LC350189 200mg, QD
LC350189 formulated capsule: Xanthine Oxidase Inhibitor
|
Placebo
n=34 Participants
Placebo, QD
Placebo: Matching placebo
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
5 Participants
n=205 Participants
|
20 Participants
n=16 Participants
|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 9.60 • n=9 Participants
|
56.6 years
STANDARD_DEVIATION 10.64 • n=6 Participants
|
54.6 years
STANDARD_DEVIATION 10.66 • n=9 Participants
|
55.4 years
STANDARD_DEVIATION 9.97 • n=205 Participants
|
54.7 years
STANDARD_DEVIATION 10.28 • n=16 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
5 Participants
n=205 Participants
|
9 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=9 Participants
|
37 Participants
n=6 Participants
|
35 Participants
n=9 Participants
|
29 Participants
n=205 Participants
|
134 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=9 Participants
|
10 Participants
n=6 Participants
|
7 Participants
n=9 Participants
|
7 Participants
n=205 Participants
|
30 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=9 Participants
|
28 Participants
n=6 Participants
|
30 Participants
n=9 Participants
|
27 Participants
n=205 Participants
|
113 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
1 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
5 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
3 Participants
n=16 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=9 Participants
|
27 Participants
n=6 Participants
|
25 Participants
n=9 Participants
|
29 Participants
n=205 Participants
|
111 Participants
n=16 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
3 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: Day 84sUA level was measured at Day 84
Outcome measures
| Measure |
LC350189 50mg
n=34 Participants
LC350189 50mg, Once a day (QD)
LC350189 formulated capsule: Xanthine Oxidase Inhibitor
|
LC350189 100mg
n=38 Participants
LC350189 100mg, QD
LC350189 formulated capsule: Xanthine Oxidase Inhibitor
|
LC350189 200mg
n=37 Participants
LC350189 200mg, QD
LC350189 formulated capsule: Xanthine Oxidase Inhibitor
|
Placebo
n=34 Participants
Placebo, QD
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Percentage of Participants With sUA (Serum Uric Acid) < 5.0 mg/dL at Day 84
|
47.1 Percentage of participants
|
44.7 Percentage of participants
|
62.2 Percentage of participants
|
2.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 84sUA level was measured at Day 84
Outcome measures
| Measure |
LC350189 50mg
n=34 Participants
LC350189 50mg, Once a day (QD)
LC350189 formulated capsule: Xanthine Oxidase Inhibitor
|
LC350189 100mg
n=38 Participants
LC350189 100mg, QD
LC350189 formulated capsule: Xanthine Oxidase Inhibitor
|
LC350189 200mg
n=37 Participants
LC350189 200mg, QD
LC350189 formulated capsule: Xanthine Oxidase Inhibitor
|
Placebo
n=34 Participants
Placebo, QD
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Percentage of Participants With sUA (Serum Uric Acid) < 6.0 mg/dL at Day 84
|
58.8 Percentage of participants
|
63.2 Percentage of participants
|
78.4 Percentage of participants
|
2.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 84sUA level was measured at Day 1, 14, 28, 56, and 84
Outcome measures
| Measure |
LC350189 50mg
n=34 Participants
LC350189 50mg, Once a day (QD)
LC350189 formulated capsule: Xanthine Oxidase Inhibitor
|
LC350189 100mg
n=38 Participants
LC350189 100mg, QD
LC350189 formulated capsule: Xanthine Oxidase Inhibitor
|
LC350189 200mg
n=37 Participants
LC350189 200mg, QD
LC350189 formulated capsule: Xanthine Oxidase Inhibitor
|
Placebo
n=34 Participants
Placebo, QD
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Maximum Percent Reduction in sUA (Serum Uric Acid) Level
|
-46.67 Percentage of reduction in sUA
Standard Deviation 13.560
|
-50.64 Percentage of reduction in sUA
Standard Deviation 19.127
|
-66.79 Percentage of reduction in sUA
Standard Deviation 15.787
|
-11.20 Percentage of reduction in sUA
Standard Deviation 8.814
|
Adverse Events
LC350189 50mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
LC350189 100mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
LC350189 200mg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LC350189 50mg
n=34 participants at risk
LC350189 50mg, Once a day (QD)
LC350189 formulated capsule: Xanthine Oxidase Inhibitor
|
LC350189 100mg
n=38 participants at risk
LC350189 100mg, QD
LC350189 formulated capsule: Xanthine Oxidase Inhibitor
|
LC350189 200mg
n=37 participants at risk
LC350189 200mg, QD
LC350189 formulated capsule: Xanthine Oxidase Inhibitor
|
Placebo
n=34 participants at risk
Placebo, QD
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrehoea
|
2.9%
1/34 • Number of events 1 • 12 weeks
|
5.3%
2/38 • Number of events 2 • 12 weeks
|
2.7%
1/37 • Number of events 1 • 12 weeks
|
2.9%
1/34 • Number of events 1 • 12 weeks
|
|
Metabolism and nutrition disorders
Gout flare
|
26.5%
9/34 • Number of events 16 • 12 weeks
|
15.8%
6/38 • Number of events 11 • 12 weeks
|
27.0%
10/37 • Number of events 15 • 12 weeks
|
17.6%
6/34 • Number of events 6 • 12 weeks
|
|
Investigations
Blood pressure increased
|
0.00%
0/34 • 12 weeks
|
2.6%
1/38 • Number of events 1 • 12 weeks
|
5.4%
2/37 • Number of events 2 • 12 weeks
|
0.00%
0/34 • 12 weeks
|
|
Investigations
Coronavirus test positive
|
5.9%
2/34 • Number of events 2 • 12 weeks
|
0.00%
0/38 • 12 weeks
|
0.00%
0/37 • 12 weeks
|
0.00%
0/34 • 12 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
2.9%
1/34 • Number of events 1 • 12 weeks
|
5.3%
2/38 • Number of events 2 • 12 weeks
|
16.2%
6/37 • Number of events 6 • 12 weeks
|
2.9%
1/34 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
2/34 • Number of events 2 • 12 weeks
|
0.00%
0/38 • 12 weeks
|
0.00%
0/37 • 12 weeks
|
0.00%
0/34 • 12 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/34 • 12 weeks
|
5.3%
2/38 • Number of events 2 • 12 weeks
|
0.00%
0/37 • 12 weeks
|
0.00%
0/34 • 12 weeks
|
|
Investigations
Transaminases increased
|
0.00%
0/34 • 12 weeks
|
0.00%
0/38 • 12 weeks
|
5.4%
2/37 • Number of events 2 • 12 weeks
|
0.00%
0/34 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place