ClinicalTrialsFinder
RecruitingPhase 4NCT06674109

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

SAVE-Care (SGLT2i As Novel Gout Care) Trial

Sponsor

Massachusetts General Hospital

Enrollment

60 participants

Start Date

May 28, 2026

Study Type

INTERVENTIONAL

Conditions

Gout and Hyperuricemia

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

  • 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.

Exclusion Criteria8

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGEmpagliflozin 10 mg

For the empagliflozin arm, participants will take 10 mg daily.

DRUGPlacebo

Participants in the placebo arm will take a placebo daily.

Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06674109