Could a diabetes pill ease swelling in liver patients?
NCT ID NCT05726032
First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 3 times
Summary
This study tests whether empagliflozin, a diabetes drug, can help people with cirrhosis and ascites (fluid buildup in the belly) get rid of excess salt and water. About 20 adults on stable diuretics will take the drug or a placebo for 14 days. Researchers will measure changes in fluid levels and kidney function to see if the drug improves fluid control.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with cirrhosis and ascites on a stable dose of diuretics (spironolactone +/- loop-diuretics based on AASLD guidelines)10 and who do not require large volume paracenteses 2. eGFR \>= 30mL/min/1.73 m2 3. \>=18 years old Exclusion Criteria: 1. Hospitalization due to a complication of cirrhosis in the previous 8 weeks (e.g. variceal hemorrhage, encephalopathy, acute kidney injury, spontaneous bacterial peritonitis) 2. Direct bilirubin \>=3 mg/dL 3. Systolic blood pressure \< 100 mmHg 4. Active malignancy including hepatocellular carcinoma undergoing treatment 5. History of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections 6. Use of SGLT-2 inhibitors in the last 10 days, or previous use with intolerance 7. Type 1 diabetes 8. History of frequent hypoglycemic episodes 9. Use of a non-loop diuretic aside from aldosterone antagonists or amiloride as they are not standard of care in patients with cirrhosis and could potentially increase the risk of hypovolemia when combined with the standard treatment for ascites along with SGLT2 inhibitor. 10. Hepatic hydrothorax requiring thoracentesis in the prior 8 weeks 11. Hepatic encephalopathy grade II or greater at the time of enrollment 12. Patients who have had TIPS placed 13. Previous liver transplant 14. Participation in another trial with an investigational drug within the 30 days prior to informed consent 15. Pregnancy or breastfeeding 16. Inability to give written informed consent or follow study protocol (e.g. clinically-significant psychiatric, addictive, or neurological disease) 17. Change in diuretic dose in the prior 2 weeks 18. Patients with hospitalization for alcoholic hepatitis in the past 6 months 19. Significant worsening of creatinine (more than 50% increase) in the past 4 weeks 20. MELD-Na \> or equal to 20 21. Hemoglobin \<8
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Yale University
RECRUITINGNew Haven, Connecticut, 06510, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can two experimental drugs be used safely in people with cirrhosis?
- Can bedside ultrasound guide fluid treatment for cirrhosis patients?