Investigational Treatment Study of AR882 in Gout Patients

1. Trial Details/Purpose

Gout affects around 8.3 million U.S. adults (4% of the population), with higher prevalence in men and those over 40. Key risk factors include obesity, high blood pressure, diabetes, and dietary choices (e.g., red meat, alcohol). It’s more common in Black and Hispanic populations. The AR882-301 trial is a Phase 3 study evaluating the safety and efficacy of AR882, a novel URAT1 inhibitor, in gout patients. The trial will enroll 750 participants, assessing serum uric acid levels and gout flare reduction.

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​2. Inclusion Criteria

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• Adults aged 18 to 85 years.

• Documented history of gout.

• At least two self-reported gout flares in the past 12 months.

• Body weight of at least 50 kg.

• For patients not on urate-lowering therapy (ULT): sUA ≥ 7 mg/dL.

• For patients on stable, medically appropriate ULT: sUA > 6 mg/dL.

• Serum creatinine < 3.0 mg/dL and estimated creatinine clearance (CLcr) ≥ 30 mL/min

3. Exclusion Criteria

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• Malignancy within the past 5 years, except for successfully treated basal or squamous cell carcinoma of the skin.

• Pregnancy or breastfeeding.

• History of symptomatic kidney stones within the past 6 months.

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​4. Benefits of Participation

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• Participants may be compensated for time and travel.

• No personal insurance is necessary.

• Participants will receive study medication at no cost.

• Before and during the study, qualified participants will meet with board-certified physicians and highly-trained and skilled research staff and receive one-on-one care.

​5. Study Location​

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     Huntington Park