Clinical trial Recruiting at 2 sites Phase 2 Interventional Ages 18 and up

HRS-2129 for Acute Gouty Arthritis: Quick Safety and Dosing Check

Official title: Clinical Study on Safety and Efficacy of HRS-2129 for Acute Gouty Arthritis

Run by Shandong Suncadia Medicine Co., Ltd. · NCT07706777 · Data updated 2026-11-12

A Phase 2 trial tests whether HRS-2129 tablets, at different doses, are safe and helpful for people with acute gouty arthritis.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment90 (estimated)
SponsorShandong Suncadia Medicine Co., Ltd.
Industry-sponsored
Locations2 sites (Guangzhou, Guangdong and 1 other locations)
StatusRecruiting
StartedAugust 19, 2026
Main results expectedOctober 2026
Study endsNovember 2026
Registry record updatedSeptember 3, 2026
Trial IDNCT07706777 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with acute gouty arthritis experiencing a target joint pain of 50 mm or higher who can provide informed consent and meet safety criteria.

Probably not a fit

Participants with significant liver/kidney dysfunction, certain cardiac conditions, or other disqualifying factors may not benefit from the treatment.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 2 study evaluates the safety and potential efficacy of HRS-2129 in adults with acute gouty arthritis. Participants receive either HRS-2129 tablets at different dose levels or placebo to identify a reasonable dosage and examine initial signals of benefit. Key eligibility requires a target joint pain score of at least 50 mm on screening and informed consent. Exclusions include significant allergies, nervous system or mental health issues, abnormal liver or kidney function, uncontrolled hypertension, certain cardiac conditions, and other factors deemed unsuitable by investigators. The trial is led by Shandong Suncadia Medicine Co., with sites in Guangzhou and Nanjing, and involves no listed collaborators.

Why it matters

Potential benefit: If successful, participants may experience reduced pain and faster improvement during an acute gout flare.

How similar studies have gone: There is limited public information on prior studies of HRS-2129 for this condition; the approach appears exploratory for this indication, with some precedent in phase II testing of targeted therapies for gout.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Subjects requiring Acute gouty arthritis
3. Target joint VAS pain score ≥ 50 mm (screening)

Exclusion Criteria:

1. Subjects with a history of severe allergies
2. Subjects with nervous system disease
3. Subjects with a history of mental illness
4. Subjects with abnormal liver and renal function
5. Subjects with poorly controlled hypertensive
6. QTc:\>450ms(male),\>470ms(female)
7. History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
8. The investigators determined that other conditions were inappropriate for participation in this clinical trial

Where it's running

  • The Third Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong, China
    Recruiting
  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
    Nanjing, Jiangsu, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.