Recruiting

Empagliflozin

Sponsor:

Massachusetts General Hospital

Code:

NCT06674109

Conditions

Gout and Hyperuricemia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Empagliflozin 10 mg

Placebo

Study Details

Brief 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.

Conditions

Gout and Hyperuricemia

Study ID

NCT06674109

Start date

Jul 1, 2026

Status verified date

Aug, 2026

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Empagliflozin 10 mg

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

Placebo

Participants in the placebo arm will take a placebo daily.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02144

Contacts

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-08-05.