Empagliflozin in Patients With Cirrhosis and Ascites

Last updated: March 25, 2025
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

2

Condition

Scar Tissue

Liver Disorders

Liver Failure

Treatment

Empagliflozin 10 MG

Matching Placebo

Clinical Study ID

NCT05726032
2000034606
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 volumeparacenteses

  2. eGFR >= 30mL/min/1.73 m2

  3. >=18 years old

Exclusion

Exclusion Criteria:

  1. Hospitalization due to a complication of cirrhosis in the previous 8 weeks (e.g.variceal hemorrhage, encephalopathy, acute kidney injury, spontaneous bacterialperitonitis)

  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 frequenturinary 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 theyare not standard of care in patients with cirrhosis and could potentially increasethe risk of hypovolemia when combined with the standard treatment for ascites alongwith 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 priorto 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

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Empagliflozin 10 MG
Phase: 2
Study Start date:
September 11, 2023
Estimated Completion Date:
September 01, 2025

Connect with a study center

  • Yale University

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

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