Gout, Hyperuricemia
Conditions
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.
Interventions
DRUGLC350189 formulated capsule
Xanthine Oxidase Inhibitor
DRUGPlacebo
Matching placebo
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With sUA (Serum Uric Acid) < 5.0 mg/dL at Day 84 | Day 84 | sUA level was measured at Day 84 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With sUA (Serum Uric Acid) < 6.0 mg/dL at Day 84 | Day 84 | sUA level was measured at Day 84 |
| Maximum Percent Reduction in sUA (Serum Uric Acid) Level | Up to Day 84 | sUA level was measured at Day 1, 14, 28, 56, and 84 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| LC350189 50mg LC350189 50mg, Once a day (QD)
LC350189 formulated capsule: Xanthine Oxidase Inhibitor | 34 |
| LC350189 100mg LC350189 100mg, QD
LC350189 formulated capsule: Xanthine Oxidase Inhibitor | 38 |
| LC350189 200mg LC350189 200mg, QD
LC350189 formulated capsule: Xanthine Oxidase Inhibitor | 37 |
| Placebo Placebo, QD
Placebo: Matching placebo | 34 |
| Total | 143 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 3 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 | 1 | 1 |
| Overall Study | Other reasons | 0 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | LC350189 50mg | LC350189 100mg | LC350189 200mg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 52.0 years STANDARD_DEVIATION 9.6 | 56.6 years STANDARD_DEVIATION 10.64 | 54.6 years STANDARD_DEVIATION 10.66 | 55.4 years STANDARD_DEVIATION 9.97 | 54.7 years STANDARD_DEVIATION 10.28 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 10 Participants | 7 Participants | 7 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 28 Participants | 30 Participants | 27 Participants | 113 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 6 Participants | 5 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 27 Participants | 25 Participants | 29 Participants | 111 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 33 Participants | 37 Participants | 35 Participants | 29 Participants | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 38 | 0 / 37 | 0 / 34 |
| other Total, other adverse events | 15 / 34 | 13 / 38 | 21 / 37 | 8 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 38 | 0 / 37 | 0 / 34 |
Outcome results
Primary
Percentage of Participants With sUA (Serum Uric Acid) < 5.0 mg/dL at Day 84
sUA level was measured at Day 84
Time frame: Day 84
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LC350189 50mg | Percentage of Participants With sUA (Serum Uric Acid) < 5.0 mg/dL at Day 84 | 47.1 Percentage of participants |
| LC350189 100mg | Percentage of Participants With sUA (Serum Uric Acid) < 5.0 mg/dL at Day 84 | 44.7 Percentage of participants |
| LC350189 200mg | Percentage of Participants With sUA (Serum Uric Acid) < 5.0 mg/dL at Day 84 | 62.2 Percentage of participants |
| Placebo | Percentage of Participants With sUA (Serum Uric Acid) < 5.0 mg/dL at Day 84 | 2.9 Percentage of participants |
Secondary
Maximum Percent Reduction in sUA (Serum Uric Acid) Level
sUA level was measured at Day 1, 14, 28, 56, and 84
Time frame: Up to Day 84
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LC350189 50mg | Maximum Percent Reduction in sUA (Serum Uric Acid) Level | -46.67 Percentage of reduction in sUA | Standard Deviation 13.56 |
| LC350189 100mg | Maximum Percent Reduction in sUA (Serum Uric Acid) Level | -50.64 Percentage of reduction in sUA | Standard Deviation 19.127 |
| LC350189 200mg | Maximum Percent Reduction in sUA (Serum Uric Acid) Level | -66.79 Percentage of reduction in sUA | Standard Deviation 15.787 |
| Placebo | Maximum Percent Reduction in sUA (Serum Uric Acid) Level | -11.20 Percentage of reduction in sUA | Standard Deviation 8.814 |
Secondary
Percentage of Participants With sUA (Serum Uric Acid) < 6.0 mg/dL at Day 84
sUA level was measured at Day 84
Time frame: Day 84
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LC350189 50mg | Percentage of Participants With sUA (Serum Uric Acid) < 6.0 mg/dL at Day 84 | 58.8 Percentage of participants |
| LC350189 100mg | Percentage of Participants With sUA (Serum Uric Acid) < 6.0 mg/dL at Day 84 | 63.2 Percentage of participants |
| LC350189 200mg | Percentage of Participants With sUA (Serum Uric Acid) < 6.0 mg/dL at Day 84 | 78.4 Percentage of participants |
| Placebo | Percentage of Participants With sUA (Serum Uric Acid) < 6.0 mg/dL at Day 84 | 2.9 Percentage of participants |