Clinical trials: Gout and Hyperuricemia
Healthy, Hyperuricemia, Gout
Acute Effects of a Urate-lowering Bacterial Therapeutic on Small Intestinal Transcriptomics and Glycomics in Healthy Subjects
This is a pilot study investigating how a novel probiotic supplement (BEO001), with and without a dietary fiber (beta-glucan), affects the lining of the small intestine in healthy people.
- Trial name
- Bugs4U-MoA (NCT07366749)
- Testing
- BEO001 Probiotic, BEO001 Probiotic + Beta-Glucan
- Where
- Sweden
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Örebro University, Sweden
Gout, Arthritis, Gouty
Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-302)
This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months
- Conditions
- Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic
- Trial name
- NCT06439602
- Testing
- AR882 50 mg, AR882 75 mg
- Where
- 68 sites in United States, Australia and 3 more
- Volunteers
- 818 people
- Sponsor
- Arthrosi Therapeutics
Gout
A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE)
This is a multicenter, randomized, double-blind, placebo-controlled phase II study assessing the efficacy, safety, and dosing regimen selection of multiple IV infusions of PRX-115 over 24 weeks, with or without MTX, versus the…
- Trial name
- RELEASE (NCT07280156)
- Testing
- PRX-115, Methotrexate (MTX)
- Where
- 35 sites in United States, Georgia and 1 more
- Volunteers
- 150 people
- Sponsor
- Protalix
Gout, Arthritis, Gouty
Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301)
This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months
- Conditions
- Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic
- Trial name
- NCT06846515
- Testing
- AR882 50 mg, AR882 75 mg
- Where
- 83 sites in United States
- Volunteers
- 866 people
- Sponsor
- Arthrosi Therapeutics
Gout
A Study of Dotinurad Versus Allopurinol in Participants With Gout
The primary objective of this study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with hyperuricemia associated with gout.
- Trial name
- NCT07089875
- Testing
- Allopurinol, Dotinurad
- Where
- 115 sites in United States, Poland and 1 more
- Volunteers
- 500 people
- Sponsor
- Crystalys Therapeutics
Tophaceous Gout
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
The primary objective of this study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with tophaceous gout.
- Trial name
- NCT07089888
- Testing
- Allopurinol, Dotinurad
- Where
- 95 sites in United States
- Volunteers
- 250 people
- Sponsor
- Crystalys Therapeutics
Hyperuricemia, Gout
Safety and Efficacy Study of MBX-102 in Treatment of Hyperuricemia in Patients With Gout
The purpose of the study is to evaluate the safety and effectiveness of MBX-102 compared to placebo when given orally once daily for 4 weeks for the treatment of hyperuricemia in patients with gout.
- Trial name
- NCT01336686
- Testing
- Arhalofenate, Colchicine
- Where
- 12 sites in United States
- Volunteers
- 67 people
- Sponsor
- Gilead Sciences
Gout, Hyperuricemia
Evaluate the PK, PD, and Safety of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Patients With Gout
The purpose of this study is to evaluate pharmacokinetics, pharmacodynamics, safety and potential for drug-drug interaction of arhalofenate when combined with febuxostat in adult population with gout.
- Trial name
- NCT02252835
- Testing
- Arhalofenate, Febuxostat, Colchicine
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Gilead Sciences
Gout, Obesity (BMI>30)
Mazdutide for Weight Management and Gout in Adults With Obesity
This is a single-arm, open-label, pre-post controlled study to evaluate the effect of Mazdutide on the annualized flare rate (AFR) in adults with obesity and gout.
- Conditions
- Gout, Obesity (BMI>30), Hyperuricemia, Metabolic Syndrome
- Trial name
- NCT07824895
- Testing
- Mazdutide
- Volunteers
- 30 people
- Sponsor
- Hongwei Jiang
Living Kidney Donation, Living Kidney Donor
Long-Term Risk of Gout in Living Kidney Donors
This population-based, matched, retrospective cohort study will evaluate the long-term risk of gout among living kidney donors compared with matched healthy nondonors, using linked administrative health care databases from…
- Conditions
- Living Kidney Donation, Living Kidney Donor, Gout, Gout and Hyperuricemia
- Trial name
- NCT07546643
- Testing
- Living kidney donation
- Volunteers
- 50,000 people, healthy volunteers welcome
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Gout and Hyperuricemia
SAVE-Care (Sodium Glucose Cotransporter-2 Inhibitors [SGLT2i] As Novel Gout Care) Trial
SAVE-Care (Sodium Glucose Cotransporter-2 inhibitors [SGLT2i] As Novel Gout Care) Trial is a double-blind randomized placebo-controlled trial (RCT) designed to assess the effect of empagliflozin on serum urate [SU] levels of gout…
- Trial name
- SAVE-Care (NCT06674109)
- Testing
- Empagliflozin 10 mg
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Massachusetts General Hospital
Refractory Gout
A Study of IN026 in Participants With Refractory Gout
The goal of this clinical study is to learn if IN026 Injection is safe and works to lower uric acid levels in adults with refractory gout (gout that does not respond well to standard treatments).
- Trial name
- NCT07587684
- Testing
- IN026 Injection
- Where
- China
- Volunteers
- 16 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hyperuricemia With or Without Gout
Safety and Food Effect on Single-Dose Bioavailability of F-02-2-Na in Healthy Adult Subjects
The study is to evaluate the impact of food on the pharmacokinetics of F-02-2-Na in healthy adult subjects by observing the changes in the drug's pharmacokinetic profile-particularly in its absorption process-before and after…
- Trial name
- NCT07346027
- Testing
- Fasting administration of F-02-2-Na (50mg) - Fed administration of F-02-2-Na (50mg), Fed administration of F-02-2-Na (50mg) - Fasting administration of F-02-2-Na (50mg)
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd.
Hyperuricemia With or Without Gout
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral F-02-2-Na Tablets in Adult Subjects
The primary objective of this study is to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of ascending single orally administered doses of F-02-2-Na in adult subjects (to include the Mass Balance) \& multiple…
- Trial name
- NCT07324434
- Testing
- F-02-2-Na Tablet (0.5 mg), F-02-2-Na Tablet (5 mg), F-02-2-Na Tablet (10 mg)
- Where
- China
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd.
Hyperuricemia With or Without Gout
Tart Cherry Citrate Effervescent Tablet for Urate-Lowering Therapy in Participants With Asymptomatic Hyperuricemia
The goal of this clinical trial is to learn whether tart cherry citrate effervescent tablets can lower uric acid levels in people with asymptomatic hyperuricemia (high uric acid levels without gout symptoms).
- Trial name
- TaCCi-HUA (NCT07613138)
- Testing
- tart cherry citrate effervescent table
- Where
- China
- Volunteers
- 196 people
- Sponsor
- Beijing Zhecheng Biotechnology Co., Ltd.
Gout, Hyperuricemia
Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia
A open label multi-center 3-period multidose, PK/PD and drug-drug interaction (DDI) study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of 7 days of treatment with two doses of dotinurad monotherapy, and to…
- Trial name
- NCT06056570
- Testing
- dotinurad, dotinurad + allopurinol, allopurinol
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- Urica Therapeutics Inc.
Hyperuricemia, Gout
Probiotic-Uricase Complex Preparation for Improving Uric Acid Metabolism in Patients With Hyperuricemia
This single-center, open-label, two-arm interventional study aims to evaluate the efficacy and safety of a probiotic-uricase complex preparation in patients with hyperuricemia.
- Trial name
- NCT07613164
- Testing
- Probiotic-uricase complex preparation
- Volunteers
- 45 people
- Sponsor
- Maanshan Shiqiye Hospital
Gout, Gouty Arthritis
Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients
This study will assess the effect of AR882 and XOI co-administration on sUA lowering as well as reducing tophus burden in the population that has failed uricase treatment (eg., pegloticase).
- Conditions
- Gout, Gouty Arthritis, Hyperuricemia, Gout Chronic
- Trial name
- NCT07116746
- Testing
- AR882 75 mg, XOI Low Dose, XOI High Dose
- Where
- 8 sites in United States
- Volunteers
- 15 people
- Sponsor
- Arthrosi Therapeutics
Primary Gout and Hyperuricemia
The Efficacy and Safety of SHR4640 Tablet Combined With 40 mg Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia
SHR4640 tablets is a highly selective and potent URAT1 inhibitors. The study is being conducted to evaluate the efficacy, and safety of SHR4640 tablet combined with 40 mg/d febuxostat tablet in reducing uric acid in subjects with…
- Trial name
- NCT07362355
- Testing
- SHR4640 ；Febuxostat, SHR4640 ; Febuxostat, SHR4640
- Where
- China
- Volunteers
- 340 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hyperuricemia With or Without Gout
The Effects of a Probiotic Food Supplement in Hyperuricaemia
The overall aim of the project is to determine whether a daily intake of health-promoting bacteria, known as probiotics, with or without a dietary fiber, affects uric acid levels in individuals with elevated levels of uric acid…
- Trial name
- Bugs4U-PoC (NCT07141888)
- Testing
- Probiotics, Probiotics plus fibre
- Where
- Sweden
- Volunteers
- 99 people
- Sponsor
- Örebro University, Sweden