NCT05726032

Empagliflozin in Patients With Cirrhosis and Ascites

Effects of Empagliflozin on Natriuresis and Volume Overload in Patients With Cirrhosis and Ascites

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.
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.

Timeline

• Start date: 2023-09-11
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-02-13
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study