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Taking people in United StatesPhase 2

Empagliflozin for fluid buildup in people with cirrhosis

Tests empagliflozin against placebo for fluid buildup in adults with cirrhosis.

Key facts

Who runs it
Yale University
Where
New Haven, United StatesSee the site
Trial code
Registry title
Empagliflozin in Patients With Cirrhosis and Ascites
Status
Recruiting
Phase
Phase 2
People taking part
20 people, planned
Started
11 Sept 2023
Expected to end
1 Dec 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Empagliflozin 10 MG
  • Matching Placebo
Record updated
14 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with cirrhosis (scarring of the liver) and fluid in the belly (ascites). They must be on a stable dose of water pills (diuretics). The trial tests empagliflozin against a placebo.

Age
18 years or older
Sex
All sexes
Disease stage
Cirrhosis with ascites that does not need large volume fluid drainage (paracentesis). MELD-Na score must be below 20. No hepatic encephalopathy grade II or greater at enrolment.
Earlier treatment
Must be on a stable dose of diuretics (spironolactone with or without loop-diuretics), with no dose change in the prior 2 weeks. Cannot have used SGLT-2 inhibitors in the last 10 days. Cannot have had TIPS or a liver transplant.
Biomarker or test result
eGFR >= 30mL/min/1.73 m2. Direct bilirubin below 3 mg/dL. Hemoglobin of at least 8.

Main reasons for not taking part

  • Hospital stay for a cirrhosis complication in the previous 8 weeks, or for alcoholic hepatitis in the past 6 months
  • Systolic blood pressure < 100 mmHg
  • Active cancer, including liver cancer under treatment
  • Bladder problems, incontinence or frequent urinary tract infections
  • Type 1 diabetes, pregnancy or breastfeeding

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

  • 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
  • eGFR >= 30mL/min/1.73 m2
  • >=18 years old

Who cannot take part

  • Hospitalization due to a complication of cirrhosis in the previous 8 weeks (e.g. variceal hemorrhage, encephalopathy, acute kidney injury, spontaneous bacterial peritonitis)
  • Use of SGLT-2 inhibitors in the last 10 days, or previous use with intolerance
  • 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
  • Hepatic hydrothorax requiring thoracentesis in the prior 8 weeks
  • Previous liver transplant
  • Participation in another trial with an investigational drug within the 30 days prior to informed consent
  • Change in diuretic dose in the prior 2 weeks
  • Active malignancy including hepatocellular carcinoma undergoing treatment
  • History of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections
  • Type 1 diabetes
  • History of frequent hypoglycemic episodes
  • Inability to give written informed consent or follow study protocol (e.g. clinically-significant psychiatric, addictive, or neurological disease)
  • Patients with hospitalization for alcoholic hepatitis in the past 6 months
  • Direct bilirubin >=3 mg/dL
  • Significant worsening of creatinine (more than 50% increase) in the past 4 weeks
  • Hemoglobin <8
  • Systolic blood pressure < 100 mmHg
  • Hepatic encephalopathy grade II or greater at the time of enrollment
  • Patients who have had TIPS placed
  • Pregnancy or breastfeeding
  • MELD-Na > or equal to 20

Where in United States

  • Yale UniversityNew Haven, United StatesContact: Jeffrey TestaniTaking people

About the trial

What the trial wants to find out

A proof-of-concept placebo-controlled trial to explore the acute and 14-day effects of empagliflozin on natriuresis and total body water in patients with cirrhosis and ascites. We will additionally investigate its effect on neurohumoral activation, and renal hemodynamics.

The 2 groups in the trial

  • EmpagliflozinExisting treatment, for comparison

    Empagliflozin vs placebo for 14 days, followed by 14 day washout period, before crossing over to the alternate drug.

    Treatment: Empagliflozin 10 MG

  • PlaceboPlacebo, for comparison

    Empagliflozin vs placebo for 14 days, followed by 14 day washout period, before crossing over to the alternate drug.

    Treatment: Matching Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effects of Empagliflozin on Natriuresis and Volume Overload in Patients With Cirrhosis and Ascites
Plain-language title
Empagliflozin for fluid buildup in people with cirrhosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
14 September 2026