CirrhosisPhase 2EMPA LiverNCT05726032
Empagliflozin in Patients With Cirrhosis and Ascites
A Phase 2 study testing Empagliflozin 10 MG in people with Cirrhosis and Liver Failure, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver Failure
- What is being tested?
- Empagliflozin 10 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2023to 1 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale University
New Haven, Connecticut, 06510
Jeffrey Testani
About this study
Official title: Effects of Empagliflozin on Natriuresis and Volume Overload in Patients With Cirrhosis and Ascites
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
- Being tested
- Empagliflozin 10 MG, Matching Placebo
- Medical subject headings
- Fibrosis, Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
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.
Matching PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Active comparator | Empagliflozin vs placebo for 14 days, followed by 14 day washout period, before crossing over to the alternate drug. Receives: Drug: Empagliflozin 10 MG |
| Placebo | Placebo comparator | Empagliflozin vs placebo for 14 days, followed by 14 day washout period, before crossing over to the alternate drug. Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FENa with administration of study drug (10 mg empagliflozin vs. identical placebo)
Change in fractional excretion of sodium with administration of study drug (10 mg empagliflozin vs. identical placebo)
Measured: 14 days
Secondary outcomes (2)
Change in renal blood flow before and after administration of study drug
Change in renal blood flow (RBF) as determined by PAH clearance, before and after the acute administration of study drug ((RPF assessed using ancillary protocol on page 31)
Measured: Baseline to Hour 6
Change in total renin, aldosterone, norepinephrine
Change in total renin, aldosterone, norepinephrine before and after a 14-day course of study drug
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start11 Sep 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Proof of concept, randomized, cross over, phase II double-blind placebo-controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Jeffrey Testani, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726032
- Sponsor's protocol ID
- 2000034606
- Acronym
- EMPA Liver
- Status last verified
- Sep 2026
- First submitted
- 2 Feb 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Empagliflozin on Natriuresis and Volume Overload in Patients With Cirrhosis and Ascites
- ClinicalTrials.gov ID
- NCT05726032
- Acronym / sponsor ID
- EMPA Liver / 2000034606
- Conditions
- Cirrhosis, Liver Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Proof of concept, randomized, cross over, phase II double-blind placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Active comparator | Drug: Empagliflozin 10 MGEmpagliflozin vs placebo for 14 days, followed by 14 day washout period, before crossing over to the alternate drug. |
| Placebo | Placebo comparator | Drug: Matching PlaceboEmpagliflozin vs placebo for 14 days, followed by 14 day washout period, before crossing over to the alternate drug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 10 MGParticipants 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 | Empagliflozin |
| Matching PlaceboParticipants 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 | Placebo |
Primary outcome
Change in FENa with administration of study drug (10 mg empagliflozin vs. identical placebo)
Time frame: 14 days
Change in fractional excretion of sodium with administration of study drug (10 mg empagliflozin vs. identical placebo)
2 secondary outcomes
Change in renal blood flow before and after administration of study drug
Time frame: Baseline to Hour 6
Change in total renin, aldosterone, norepinephrine
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey Testani, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Empagliflozin 10 MG in people with Cirrhosis and Liver Failure, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veena Rao, PHD (2037373571, veena.s.rao@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FENa with administration of study drug (10 mg empagliflozin vs. identical placebo) (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.