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Completed

NCT Number: NCT06139393

Clinical Study of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults

The study is being conducted to evaluate the efficacy, and safety of HR091506 tablets for treatment of gout with hyperuricemia in adults, and to compare the results with febuxostat tablets in the same doses.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-75 years old, male or female;
  • BMI: 18.0-30.0 kg/m2;
  • Meet the 2015 ACR/EULAR gout classification criteria;
  • Fast serum uric acid ≥ 480 μmol/L on 2 different days during the screening perid;
  • Willing to ues contraceptive measures during the study;
  • Able and willing to provide a written informed consent.

Exclusion criteria

  • History of acute gout attack within 4 weeks before randomization.
  • Subjects who have undergone major surgery or organ transplantation within 3 months before randomization.
  • Subjects with major cardiovascular disease within 6 months before randomization.
  • History of chronic infection or recurrent infection within 1year before randomization.
  • History of malignant tumor or current history of combined malignant tumor within 5 years before screening.
  • History of secondary hyperuricemia, refractory gout, or xanthine metabolism disorder.
  • Subjects with poorly controlled blood pressure or diabetes mellitus.
  • History of chronic diffuse connective tissue disease and/or massively elevated urate diseases and/or untreated clinically significant thyroid disease.
  • History of diseases that may affect the in vivo process, safety evaluation, or subjects' participation in the research.
  • Abnormal laboratory tests that may affect subjects participating in the research.
  • Combined use of prohibited drugs.
  • Allergic to ingredient or component of the experimental drug.
  • Participated in other clinical trials within 1 month before randomization.
  • Pregnant or nursing women.
  • History of drug abuse, drug use and/or excessive drinking within 1 year before screening.
  • The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Treatment and study plan

HR091506 tablets + placebo of febuxostat tablets

Drug

HR091506 tablets 20mg qd + placebo of febuxostat tablets 20mg qd from Week 1 to 4, HR091506 tablets 40mg qd + placebo of febuxostat tablets 40mg qd from Week 5 to 28.

febuxostat tablets + placebo of HR091506 tablets

Drug

febuxostat tablets 20mg qd + placebo of HR091506 tablets 20mg qd from Week 1 to 4, febuxostat tablets 40mg qd + placebo of HR091506 tablets 40mg qd from Week 5 to 28.

Primary outcomes

  1. The proportion of subjects with serum uric acid level < 360 μmoL/L at Week 28

    Time frame: Week 28

Secondary outcomes

  1. Proportion of subjects with serum uric acid level < 360 μmol/L at each visit.

    Time frame: at week 4,8,12,16,20and24 after administration

  2. Proportion of subjects with serum uric acid level < 300 μmol/L at each visit

    Time frame: at week 4,8,12,16,20,24and28 after administration

  3. Change of serum uric acid level from baseline to every visit

    Time frame: at week 4,8,12,16,20,24 and28 after administration

  4. Proportion of subjects with ≥1 gout flare during treatment stage

    Time frame: during treatment stage

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

Study on Efficacy and Safety of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2023
Registry last updated
Oct 2, 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.