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

Conditions

• Gout and Hyperuricemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Empagliflozin 10 mg — DRUG
  For the empagliflozin arm, participants will take 10 mg daily.
• Placebo — DRUG
  Participants in the placebo arm will take a placebo daily.

Study Details

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 Dates

Start date

May 28, 2026

Status verified

Jun 2026

Primary completion

Feb 28, 2028

Completion

Feb 28, 2028

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Empagliflozin 10mg
  Participants in this arm will take empagliflozin 10mg daily
• Placebo Comparator: Placebo
  Participants in this arm will take a placebo daily

Primary Outcome Measure

Serum Urate Change [ Time Frame: Screening to three months of follow-up ]

Central Contacts

• Ana D Fernandes, MA
  617-643-2140
  [email protected]

Locations (1)

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