Gout With Hyperuricemia in AdultsPhase 3NCT06139393
Clinical Study of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults
A Phase 3 study of Gout With Hyperuricemia in Adults, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gout With Hyperuricemia in Adults
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 765 participants
- Where
- 1 siteChina
- Study dates
- 14 Dec 2023to 4 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Study on Efficacy and Safety 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.
- Conditions
- Gout With Hyperuricemia in Adults
- Being tested
- HR091506 tablets + placebo of febuxostat tablets, febuxostat tablets + placebo of HR091506 tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR091506 tablets + placebo of febuxostat tabletsDrug
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 tabletsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HR091506 tablets + placebo of febuxostat tablets | Experimental | Not described Receives: Drug: HR091506 tablets + placebo of febuxostat tablets |
| Treatment group B: febuxostat tablets + placebo of HR091506 tablets | Active comparator | Not described Receives: Drug: febuxostat tablets + placebo of HR091506 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with serum uric acid level < 360 μmoL/L at Week 28
Measured: Week 28
Secondary outcomes (4)
Proportion of subjects with serum uric acid level < 360 μmol/L at each visit.
Measured: at week 4,8,12,16,20and24 after administration
Proportion of subjects with serum uric acid level < 300 μmol/L at each visit
Measured: at week 4,8,12,16,20,24and28 after administration
Change of serum uric acid level from baseline to every visit
Measured: at week 4,8,12,16,20,24 and28 after administration
Proportion of subjects with ≥1 gout flare during treatment stage
Measured: during treatment stage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start14 Dec 2023
- Primary completion18 Aug 2025
- Study completion4 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gout With Hyperuricemia in AdultsStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 765 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139393
- Sponsor's protocol ID
- HR091506-302
- Status last verified
- Sep 2025
- First submitted
- 15 Nov 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Efficacy and Safety of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults
- ClinicalTrials.gov ID
- NCT06139393
- Acronym / sponsor ID
- HR091506-302
- Conditions
- Gout With Hyperuricemia in Adults
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 765 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 4 Sep 2025 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: HR091506 tablets + placebo of febuxostat tablets | Experimental | Drug: HR091506 tablets + placebo of febuxostat tablets |
| Treatment group B: febuxostat tablets + placebo of HR091506 tablets | Active comparator | Drug: febuxostat tablets + placebo of HR091506 tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR091506 tablets + placebo of febuxostat tabletsHR091506 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. | Drug | Treatment group A: HR091506 tablets + placebo of febuxostat tablets |
| febuxostat tablets + placebo of HR091506 tabletsfebuxostat 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. | Drug | Treatment group B: febuxostat tablets + placebo of HR091506 tablets |
Primary outcome
The proportion of subjects with serum uric acid level < 360 μmoL/L at Week 28
Time frame: Week 28
4 secondary outcomes
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
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
Change of serum uric acid level from baseline to every visit
Time frame: at week 4,8,12,16,20,24 and28 after administration
Proportion of subjects with ≥1 gout flare during treatment stage
Time frame: during treatment stage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Gout With Hyperuricemia in Adults, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects with serum uric acid level < 360 μmoL/L at Week 28 (time frame: Week 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.