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NCT05818085
Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout
Phase 2, PHASE3 trial testing ABP-671 in Gout in 300 participants. Completed in 30 March 2025.
30 January 2025
Quick facts
| Lead sponsor | Atom Therapeutics Co., Ltd |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 300 |
| Start date | 11 August 2023 |
| Primary completion | 30 January 2025 |
| Estimated completion | 30 March 2025 |
| Sites | 57 locations across Georgia, Taiwan, Australia, Guatemala, United States |
Drugs / interventions tested
- ABP-671 — full drug profile →
- Allopurinol (ALLOPURINOL) — full drug profile →
- Placebo
Conditions studied
- Gout — all drugs for Gout →
Sponsor
Atom Therapeutics Co., Ltd — full company profile →
Who can join
Adults 19 to 75, any sex, with Gout. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, randomized, double-blind, Phase 2b/3 study to evaluate the efficacy and safety of ABP-671. Part 1 of the study will compare the efficacy and safety of different doses and regimens of ABP-671 with placebo and allopurinol. Part 2 of the study will compare the dosing regimen(s) of ABP-671 selected from Part 1 with placebo in participants who have not been enrolled for Part 1.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Structural Basis for Inhibition of Urate Reabsorption in URAT1.
Fan J, Xie W, Ke H, Zhang J, et al · · 2025 · cited 3× · PMID 40151250 · DOI 10.1021/jacsau.4c01188
Verify or expand the search:
- PubMed search for NCT05818085
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ABP-671
Trials testing the same drug.
- NCT06276556 — Extension Study of ABP-671 in Participants With Gout · Phase 2, PHASE3 · terminated
- NCT04638543 — A Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 in Patients With Gout or Hyperuricemia · Phase 2 · completed
- NCT04303039 — Study to Investigate the Effects of Food on Relative Bioavailability of ABP-671 Tablets in Healthy Subjects · Phase 1 · completed
- NCT04060173 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 · Phase 1 · completed
- NCT03906006 — A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 in Healthy Subjects · Phase 1 · completed
Other recruiting trials for Gout
Currently open trials in the same condition.
- NCT07414394 — Tigulixostat (IBI128) vs Febuxostat in Gout · Phase 3 · recruiting
- NCT07367971 — Drug-Drug Interaction Study of ABP-671 in Gout Patients · Phase 1 · recruiting
- NCT07346079 — Purified Cortrophin® Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares · Phase 4 · recruiting
- NCT07089875 — A Study of Dotinurad Versus Allopurinol in Participants With Gout · Phase 3 · recruiting
- NCT05507723 — Tight Control of Gouty Arthritis Compared to Usual Care · NA · recruiting
Other Atom Therapeutics Co., Ltd trials
Trials by the same sponsor.
- NCT07323095 — Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia · Phase 2 · not yet recruiting
- NCT07367971 — Drug-Drug Interaction Study of ABP-671 in Gout Patients · Phase 1 · recruiting
- NCT06276556 — Extension Study of ABP-671 in Participants With Gout · Phase 2, PHASE3 · terminated
- NCT06258213 — A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral ABP-745 Administration in Healthy Volunteers · Phase 1 · completed
- NCT04638543 — A Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 in Patients With Gout or Hyperuricemia · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05818085 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Atom Therapeutics Co., Ltd
- Last refreshed: 22 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05818085.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing