Empagliflozin in Patients With Cirrhosis and Ascites

NCT ID: NCT05726032

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-11
• Study Completion Date: 2025-12-01

Brief 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.

Conditions

Cirrhosis; Liver Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Empagliflozin

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

Group Type: ACTIVE_COMPARATOR

Empagliflozin 10 MG

Intervention Type: DRUG

Participants will be randomized to Empagliflozin 10 mg or placebo for 14 days. A 14 day washout period follows and then participants is crossed over to the alternate treatment for 14 days.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Matching Placebo

Intervention Type: DRUG

Participants will be randomized to Empagliflozin 10 mg or placebo for 14 days. A 14 day washout period follows and then participants is crossed over to the alternate treatment for 14 days.

Interventions

Empagliflozin 10 MG

Participants will be randomized to Empagliflozin 10 mg or placebo for 14 days. A 14 day washout period follows and then participants is crossed over to the alternate treatment for 14 days.

Intervention Type: DRUG

Matching Placebo

Participants will be randomized to Empagliflozin 10 mg or placebo for 14 days. A 14 day washout period follows and then participants is crossed over to the alternate treatment for 14 days.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Testani, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Veena Rao, PHD

Role: CONTACT

veena.s.rao@yale.edu

2037373571

Kara Otis

Role: CONTACT

kara.otis@yale.edu

2037373571

Facility Contacts

Katherine Keith

Role: primary

Other Identifiers

2000034606

Identifier Type: -

Identifier Source: org_study_id