Gout and HyperuricemiaPhase 4SAVE-CareNCT06674109
SAVE-Care (Sodium Glucose Cotransporter-2 Inhibitors [SGLT2i] As Novel Gout Care) Trial
A Phase 4 study testing Empagliflozin 10 mg in people with Gout and Hyperuricemia, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gout and Hyperuricemia
- What is being tested?
- Empagliflozin 10 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 28 Feb 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02144
Hyon K Choi, MD, 6177265650, hchoi@mgh.harvard.edu
About this study
Official title: SAVE-Care (SGLT2i As Novel Gout Care) Trial
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.
Read the detailed description
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.
- Conditions
- Gout and Hyperuricemia
- Being tested
- Empagliflozin 10 mg, Placebo
- Medical subject headings
- Gout, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 mgDrug
Also called Jardiance
For the empagliflozin arm, participants will take 10 mg daily.
PlaceboDrug
Participants in the placebo arm will take a placebo daily.
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin 10mg | Experimental | Participants in this arm will take empagliflozin 10mg daily Receives: Drug: Empagliflozin 10 mg |
| Placebo | Placebo comparator | Participants in this arm will take a placebo daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening to three months of follow-up
Secondary outcomes (4)
Changes in highly selective C-reactive protein (hsCRP)
hs-CRP levels will be measured at screening and Week 12
Measured: 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.
Measured: 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).
Measured: Baseline to three months of follow-up
Changes in Interleukin 6 [IL-6]
IL-6 levels will be measured at screening and 12 weeks.
Measured: Screening to three months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Jul 2026
- Primary completion1 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gout and HyperuricemiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Hyon Choi, Massachusetts General Hospital
- Investigators
- Hyon K Choi, MD, DrPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674109
- Sponsor's protocol ID
- 2024P003219
- Other IDs
- 1R61AR084188-01A1
- Acronym
- SAVE-Care
- Status last verified
- Aug 2026
- First submitted
- 30 Oct 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAVE-Care (SGLT2i As Novel Gout Care) Trial
- ClinicalTrials.gov ID
- NCT06674109
- Acronym / sponsor ID
- SAVE-Care / 2024P003219
- Conditions
- Gout and Hyperuricemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin 10mg | Experimental | Drug: Empagliflozin 10 mgParticipants in this arm will take empagliflozin 10mg daily |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in this arm will take a placebo daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 10 mgAlso: JardianceFor the empagliflozin arm, participants will take 10 mg daily. | Drug | Empagliflozin 10mg |
| PlaceboParticipants in the placebo arm will take a placebo daily. | Drug | Placebo |
Primary outcome
Serum Urate Change
Time frame: Screening to three months of follow-up
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.
4 secondary outcomes
Changes in highly selective C-reactive protein (hsCRP)
Time frame: Screening to three months of follow-up
Gout flares
Time frame: Screening to three months of follow-up
Medication Adherence
Time frame: Baseline to three months of follow-up
Changes in Interleukin 6 [IL-6]
Time frame: Screening to three months of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hyon K Choi, MD, DrPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin 10 mg in people with Gout and Hyperuricemia, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana D Fernandes, MA (617-643-2140, adfernandes@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Urate Change (time frame: Screening to three months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.