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

NCT06674109 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 2024P0032191R61AR084188-01A1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Screening to three months of follow-up

Secondary Outcomes (4)

• Changes in highly selective C-reactive protein (hsCRP)

  Screening to three months of follow-up

• Gout flares

  Screening to three months of follow-up

• Medication Adherence

  Baseline to three months of follow-up

• Changes in Interleukin 6 [IL-6]

  Screening to three months of follow-up

Other Outcomes (4)

• Quality of Life Measures (36-Item Short Form Survey)

  Screening to two months of follow-up

• Quality of Life Assessment [GAQ]

  Screening to three months after baseline

• Tophi Measurement

  Screening

Study Arms (2)

Empagliflozin 10mg

EXPERIMENTAL

Participants in this arm will take empagliflozin 10mg daily

Drug: Empagliflozin 10 mg

Placebo

PLACEBO COMPARATOR

Participants in this arm will take a placebo daily

Drug: Placebo

Interventions

Empagliflozin 10 mg DRUG

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

Also known as: Jardiance

Empagliflozin 10mg

Placebo DRUG

Participants in the placebo arm will take a placebo daily.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• + 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Gout; Hyperuricemia

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hyon K Choi, MD, DrPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana D Fernandes, MA

CONTACT

617-643-2140; adfernandes@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 5, 2024
• Study Start: April 30, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03