NCT05726032 · Yale University
Empagliflozin in Patients With Cirrhosis and Ascites
(EMPA Liver)
What this study is about
A proof-of-concept compared against an inactive treatment 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- New Haven, Connecticut
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 19, 2026 · Source of record for eligibility and locations