Empagliflozin in Patients With Cirrhosis and Ascites

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Cirrhosis, Liver Failure

In brief

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.

Key facts

Study ID

NCT05726032

Run by

Yale University

People needed

20

Starts

2023-09-11

Expected to finish

2026-06-01

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Yale University — New Haven, Connecticut, United States (enrolling)

Full record on ClinicalTrials.gov

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