New gout pill shows promise in lowering uric acid levels
NCT ID NCT06139393
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new tablet called HR091506 in 765 adults with gout and high uric acid. The goal was to see if it could lower uric acid levels better than an existing drug, febuxostat. Participants took the medicine for 28 weeks, and doctors checked their uric acid levels regularly.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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765 people
The number who actually took part.
- Started
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Dec 2023
- Finished
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Sep 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 18-75 years old, male or female; 2. BMI: 18.0-30.0 kg/m2; 3. Meet the 2015 ACR/EULAR gout classification criteria; 4. Fast serum uric acid ≥ 480 μmol/L on 2 different days during the screening perid; 5. Willing to ues contraceptive measures during the study; 6. Able and willing to provide a written informed consent. Exclusion Criteria: 1. History of acute gout attack within 4 weeks before randomization. 2. Subjects who have undergone major surgery or organ transplantation within 3 months before randomization. 3. Subjects with major cardiovascular disease within 6 months before randomization. 4. History of chronic infection or recurrent infection within 1year before randomization. 5. History of malignant tumor or current history of combined malignant tumor within 5 years before screening. 6. History of secondary hyperuricemia, refractory gout, or xanthine metabolism disorder. 7. Subjects with poorly controlled blood pressure or diabetes mellitus. 8. History of chronic diffuse connective tissue disease and/or massively elevated urate diseases and/or untreated clinically significant thyroid disease. 9. History of diseases that may affect the in vivo process, safety evaluation, or subjects' participation in the research. 10. Abnormal laboratory tests that may affect subjects participating in the research. 11. Combined use of prohibited drugs. 12. Allergic to ingredient or component of the experimental drug. 13. Participated in other clinical trials within 1 month before randomization. 14. Pregnant or nursing women. 15. History of drug abuse, drug use and/or excessive drinking within 1 year before screening. 16. The investigators determined that other conditions were inappropriate for participation in this clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, 100034, China