SGLT2 Inhibitor as Novel Gout Care in Gout with Hyperuricemia
Official title: SAVE-Care (SGLT2i As Novel Gout Care) Trial
Run by Massachusetts General Hospital · NCT06674109 · Data updated 2026-11-12
A 12-week study tests whether empagliflozin 10 mg daily can lower serum urate in adults with gout and high uric acid.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | February 1, 2028 |
| Study ends | February 28, 2028 |
| Registry record updated | August 5, 2026 |
| Trial ID | NCT06674109 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–80 with gout and hyperuricemia meeting ACR/EULAR criteria, at least one gout flare in the past year, and no major exclusions like eGFR <20 mL/min or active CVD.
✕Probably not a fit
Patients with markedly reduced kidney function, active cardiovascular disease, or those using colchicine/NSAID prophylaxis may not benefit or could be at risk.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 4, double-blind, randomized, placebo-controlled trial will compare empagliflozin 10 mg once daily to placebo in 60 adults with gout and hyperuricemia. The primary endpoint is change in serum urate, with secondary measures including hsCRP, IL-6, and frequency of gout flares over 12 weeks. The trial aims to generate high-quality evidence to inform future larger studies and potentially update gout care guidelines. It is conducted at Massachusetts General Hospital with NIAMS as a collaborator. If successful, the study could support SGLT2 inhibitors as a urate-lowering therapy in selected gout patients.
Why it matters
Potential benefit: If successful, empagliflozin could reduce serum urate and inflammation, potentially lowering gout flare risk.
How similar studies have gone: There is evidence from other fields that SGLT2 inhibitors affect urate and inflammatory markers, but this gout-specific RCT is among the first to test this endpoint.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision of signed and dated informed consent form. 2. Fulfilling American College of Rheumatology \[ACR\]/European Alliance of Associations for Rheumatology \[EULAR\] gout criteria 3. 1+ gout flares in last 12 months 4. Serum urate level ≥ 6mg/dl 5. Males and females; Age 18-80 6. Willingness to adhere to the study intervention procedures. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Estimated Glomerular Filtration Rate \[eGFR\] \<20ml/min 2. Colchicine or nonsteroidal anti-inflammatory drug \[NSAID\] prophylaxis 3. active cardiovascular disease \[CVD\], type-1 diabetes 4. pregnant and lactating women 5. Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation. \[History of ketoacidosis, end-stage or decompensated liver disease, active cancer\] 6. Use of anti-obesity drugs 7. Basal-bolus or multiple daily injection insulin regimens, or loop diuretics
Where it's running
-
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Hyon K Choi, MD, DrPH — Massachusetts General Hospital
- Study coordinator: Ana D Fernandes, MA
- Email: adfernandes@mgh.harvard.edu
- Phone: 617-643-2140
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.