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Empagliflozin in Patients With Cirrhosis and Ascites

Study acronym: EMPA Liver
StatusRecruiting
PhasePhase 2
Started2023-09-11
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Jun 1, 2026 → Dec 1, 2026
Primary endpoint removed 2 → 1 primary endpoints
See other at-risk trials from Yale University

Amendment history

2026-09-10
Study Status, Outcome Measures, Contacts/Locations v8
Primary endpoint(s) modified2 to 1 entries
WasChange in FENa with administration of study drug (10 mg empagliflozin vs. identical placebo), Change in total body water (TBW) before and after a 14-day course of study drug
NowChange in FENa with administration of study drug (10 mg empagliflozin vs. identical placebo)
Secondary endpoints2 entries, revised
Change in plasma renin activity,total renin, aldosterone, norepinephrine and copeptin
Study sitescontacts updated at 1 of 1 site
2026-08-20
Study Status v7
Primary completion pushed: 2026-06-01 → 2026-12-01
Completion pushed: 2026-06-01 → 2026-12-01
2026-02-17
Study Status v6
Primary completion date2025-12-01→2026-06-01
Completion date2025-12-01→2026-06-01
2025-10-06
Study Status v5
Primary completion date2025-09-01→2025-12-01
Completion date2025-09-01→2025-12-01
2025-03-25
Study Status v4
Re-verified, no change to tracked fields
Show 3 earlier versions
2024-04-02
Study Status, Sponsor/Collaborators, Eligibility, Contacts/Locations v3
Primary completion date2024-04-01→2025-09-01
Completion date2024-10-01→2025-09-01
Eligibility criteria+85 characters
[...] se of a non-loop diuretic aside from aldosterone antagonists or amiloride as they are not standard of care in patients with cirrhosis [...] 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 e [...] neurological disease) Change in diuretic dose in the prior 42 weeks Patients with hospitalization for alcoholic hepatitis [...] tinine (more than 50% increase) in the past 4 weeks MELD-Na > or equal to 20 Hemoglobin <208
Collaborators+20 characters
Boehringer Ingelheim
2023-09-26
Study Status v2
Start date2023-04-27→2023-09-11
2023-05-01
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-04-01→confirmed 2023-04-27
Study sites0→1
2023-02-02
Original filing
Yale University
487 trials monitored
See 35 trials at risk
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.
Trial Details
NCT Number NCT05726032
Lead Sponsor Yale University
Collaborators: Boehringer Ingelheim
Conditions Cirrhosis, Liver Failure
Enrollment 20 participants
Start Date 2023-09-11
Primary Completion 2026-12-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-14