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Could a diabetes pill ease swelling in liver patients?

NCT ID NCT05726032

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06510, United States

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