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CompletedPhase 3

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

Key facts

Who runs it
Jiangsu HengRui Medicine Co., Ltd.
Where
China1 site in 1 countryChoose a country to see its sites
Trial code
Status
Completed
Phase
Phase 3
People taking part
765 people enrolled
Started
14 Dec 2023
Ended
4 Sept 2025
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • HR091506 tablets + placebo of febuxostat tablets
  • febuxostat tablets + placebo of HR091506 tablets
Record updated
2 October 2025

Who can take part

Age
18 years to 75 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Combined use of prohibited drugs
  • Participated in other clinical trials within 1 month 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
  • Allergic to ingredient or component of the experimental drug
  • 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
  • Abnormal laboratory tests that may affect subjects participating in the research
  • Pregnant or nursing women

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Treatment group A: HR091506 tablets + placebo of febuxostat tabletsTreatment being tested

    Treatment: HR091506 tablets + placebo of febuxostat tablets

  • Treatment group B: febuxostat tablets + placebo of HR091506 tabletsExisting treatment, for comparison

    Treatment: febuxostat tablets + placebo of HR091506 tablets

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Study on Efficacy and Safety of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults
Record updated
2 October 2025