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Completed

NCT Number: NCT03934099

A Study to Assess Efficay and Safety of LC350189 Different Doses 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.

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Key information

Conditions

Gout Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Hyperuricemia Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Synexus Clinical Research, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

LC350189 formulated capsule

Drug

Xanthine Oxidase Inhibitor

Placebo

Drug

Matching placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. Percentage of Participants With sUA (Serum Uric Acid) < 6.0 mg/dL at Day 84

    Time frame: Day 84

    sUA level was measured at Day 84

  2. Maximum Percent Reduction in sUA (Serum Uric Acid) Level

    Time frame: Up to Day 84

    sUA level was measured at Day 1, 14, 28, 56, and 84

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 1, 2019
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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