Last updated: September 22, 2023
Sponsor: LG Chem
Overall Status: Active - Recruiting
Phase
3
Condition
Gout (Hyperuricemia)
Treatment
N/AClinical Study ID
TX318211
LG-GDCL010
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female subjects between the ages of 18-85 years, inclusive.
- Subjects with hyperuricemia and a history or presence of gout per American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2015 criteria.
- Subjects who are currently on urate-lowering therapies (ULT) with an sUA level ≥6.0 mg/dL at screening (Visit 1); or subjects who are currently not on ULT with an sUA level ≥7.0 mg/dL at screening (Visit 1). Subjects currently on ULT will undergo washout and must have an sUA level ≥7.0 mg/dL at Visit 3 to be randomized and participate in the study.
- Subjects with a Body Mass Index ≤50 kg/m2 and estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at screening (Visit 1).
Exclusion
Exclusion Criteria:
- Subjects with secondary hyperuricemia and enzymatic defects.
- Subjects experiencing an acute gout attack (intense pain, swelling, or/and tenderness in the joint area) within 2 weeks prior to screening (Visit 1).
- Subjects who have received pegloticase to treat gout which has not responded to the usual treatments.
- Subjects who have not been receiving stable doses of drugs known to affect sUA levels for the last 3 weeks prior to screening (Visit 1).
- Subjects with a history of xanthinuria (elevated levels of xanthine in the urine).
Study Design
Study Start date:
Estimated Completion Date:
Study Description
Connect with a study center
AMR Kansas City (formerly Center for Pharmaceutical Research)
Kansas City, Missouri 64114
United StatesActive - Recruiting
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