A Phase 4 interventional study of Empagliflozin 10 mg and Placebo in Gout and Hyperuricemia, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Treatment
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.
With the compelling premise as above, prospective gout-patient-specific RCTs for key gout disease endpoints are needed to provide high-level evidence needed to impact practice change with a great likelihood to revolutionize gout care as SGLT2i did in cardiology, diabetology, and nephrology. To that end, the investigators propose to conduct the first RCT of SGLT2i specifically among gout patients with hyperuricemia (SAVE-Care [SGLT2i As Novel Gout Care] Trial) for the endpoint of serum urate, the central outcome in clinical care, trials, and FDA approvals, as discussed above. Specifically, the investigators will conduct a double-blind RCT of 60 gout patients, with 2 parallel arms of empagliflozin 10mg daily vs. placebo in a 2:1 ratio over 12 weeks.
The SAVE-Care trial will fill an important evidence gap by determining the magnitude of SU reduction specifically in patients with well-characterized gout, and with hyperuricemia and recent flares, for whom gout treatment would be indicated. If SU reduction is substantial (e.g. >\~1.5mg/dL) as hypothesized in Aim 1, SGLT2i will be considered a useful urate-lowering gout therapy given their proven cardiovascular [CV]-kidney-metabolic benefits, particularly for typical cases managed by primary care or those with indicated CV-kidney metabolic comorbidities. However, if the urate-lowering capacity among gout patients is relatively small, SGLT2i's clinical utility for SU control purpose (vs flare control alone) will be considered limited. To that end, SU outcomes data generated by the SAVE-Care trial in relevant gout patients will be directly applicable to clinical gout care.
The SAVE-Care trial will also provide first prospective RCT outcomes data on two relevant inflammatory markers (i.e., hs-CRP and IL-6) among gout patients to assess the anti-inflammatory potentials of SGLT2i relevant to gout. Furthermore, SAVE-Care trial will generate estimates for gout flare risks and rates in the empagliflozin and in the placebo group over 12 weeks, which will serve as important preliminary data to developing a future full-scale RCT for clinical endpoints. All in all, with the overarching goal of improving gout outcomes and its comorbidities together, this study will not only generate immediately actionable evidence on the central outcome of SU, the causal biomarker of gout, but also key data on inflammatory markers, flares, and medication adherence in SGLT2i and placebo to inform future trials.
345 studies on the registry are indexed under Gout; 49 are open to participants now.
This study's planned enrollment of 60 is below the median of 83 across 286 interventional studies indexed under Gout.
Browse Gout studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will take empagliflozin 10mg daily
Drug: Empagliflozin 10 mg
Participants in this arm will take a placebo daily
Drug: Placebo
For the empagliflozin arm, participants will take 10 mg daily.
Also known as: Jardiance
Participants in the placebo arm will take a placebo daily.
Serum Urate Change
Change in serum urate \[SU\] levels as compared with controls at Week 12. SU levels will be obtained at screening and Week 4, 8, and 12.
Time frame: Screening to three months of follow-up
Changes in highly selective C-reactive protein (hsCRP)
hs-CRP levels will be measured at screening and Week 12
Time frame: Screening to three months of follow-up
Gout flares
Gout flares will be ascertained using the Gaffo criteria, which requires presence of three or more out of the four items included in the flare diary and asked at each study visit: 1) subject-defined gout-flare, 2) pain at rest \>3 on a 0-10 numeric scale, 3) presence of at least one swollen joint, and 4) presence of at least one warm joint.
Time frame: Screening to three months of follow-up
Medication Adherence
Adherence to empagliflozin or placebo, defined by taking 80% or more of the dispensed doses and calculated by the number of pills taken (pills dispensed - pills counted).
Time frame: Baseline to three months of follow-up
Changes in Interleukin 6 [IL-6]
IL-6 levels will be measured at screening and 12 weeks.
Time frame: Screening to three months of follow-up
Quality of Life Measures (36-Item Short Form Survey)
The 36-Item Short Form Survey \[SF-36\] will be administered at screening and eight weeks later to measure quality of life measures
Time frame: Screening to two months of follow-up
Quality of Life Assessment [GAQ]
The Gout Assessment Questionnaire \[GAQ\] will be administered at screening and every monthly visit for the full three month period to assess quality of life in specific regards to gout outcomes.
Time frame: Screening to three months after baseline
Tophi Measurement
If tophi are present in participants at screening, tophi will be measured for the maximum diameter of the longest tophus using a Vernier caliper and the total number and sites of tophi.
Time frame: Screening
Work Productivity and Activity Impairment Questionnaire [WPAI]
Participant absences from work and other work-related outcomes will be measured at every visit from screening to the final visit twelve weeks later
Time frame: Screening to three months of follow-up
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