SAVE-Care (Sodium Glucose Cotransporter-2 Inhibitors [SGLT2i] As Novel Gout Care) Trial

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Gout and Hyperuricemia

In brief

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 patients, as well as levels of highly-sensitivity C-reactive protein \[hsCRP\] and interleukin 6 \[IL-6\], and estimate gout flares over 3 months, in order to develop a full-scale RCT of clinical endpoints to directly inform gout care guidelines.

Key facts

Study ID

NCT06674109

Run by

Massachusetts General Hospital

People needed

60

Starts

2026-07-01

Expected to finish

2028-02-28

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Provision of signed and dated informed consent form.
• Fulfilling American College of Rheumatology [ACR]/European Alliance of Associations for Rheumatology [EULAR] gout criteria
• 1+ gout flares in last 12 months
• Serum urate level ≥ 6mg/dl
• Males and females; Age 18-80
• Willingness to adhere to the study intervention procedures.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Estimated Glomerular Filtration Rate [eGFR] <20ml/min
• Colchicine or nonsteroidal anti-inflammatory drug [NSAID] prophylaxis
• active cardiovascular disease [CVD], type-1 diabetes
• pregnant and lactating women
• 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]
• Use of anti-obesity drugs
• Basal-bolus or multiple daily injection insulin regimens, or loop diuretics

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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