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Sodium-glucose cotransporter 2 (SGLT2) inhibitor

Empagliflozin for Cirrhosis with Ascites (EMPA Liver Trial)

Phase 2
Recruiting
Led By Jeffrey Testani, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days

Summary

This trial will investigate how a diabetes drug affects water balance and other bodily functions in people with cirrhosis.

Who is the study for?
This trial is for adults over 18 with cirrhosis and ascites who are on stable diuretic therapy, have an eGFR of at least 30 mL/min/1.73 m2, and haven't been hospitalized for cirrhosis complications in the last 8 weeks. People with direct bilirubin >=3 mg/dL, low blood pressure, active cancers, certain urinary issues, type 1 diabetes or those pregnant/breastfeeding cannot join.
What is being tested?
The study tests Empagliflozin's effects on salt excretion and body water in patients with liver scarring (cirrhosis) and fluid accumulation (ascites). It compares Empagliflozin to a placebo over two weeks to see if it changes hormone levels affecting the kidneys.
What are the potential side effects?
Empagliflozin may cause dehydration due to increased urination, low blood sugar levels especially in diabetic patients, urinary tract infections due to its action on glucose in urine which can promote bacterial growth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change 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
Secondary study objectives
Change in plasma renin activity,total renin, aldosterone, norepinephrine and copeptin
Change in renal blood flow before and after administration of study drug

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: EmpagliflozinActive Control1 Intervention
Empagliflozin vs placebo for 14 days, followed by 14 day washout period, before crossing over to the alternate drug.
Group II: PlaceboPlacebo Group1 Intervention
Empagliflozin vs placebo for 14 days, followed by 14 day washout period, before crossing over to the alternate drug.

Find a Location

Who is running the clinical trial?

Boehringer IngelheimIndustry Sponsor
2,550 Previous Clinical Trials
15,769,273 Total Patients Enrolled
12 Trials studying Liver Failure
430 Patients Enrolled for Liver Failure
Yale UniversityLead Sponsor
1,924 Previous Clinical Trials
3,031,638 Total Patients Enrolled
Jeffrey Testani, MDPrincipal InvestigatorYale University
6 Previous Clinical Trials
619 Total Patients Enrolled

Media Library

Empagliflozin 10 MG (Sodium-glucose cotransporter 2 (SGLT2) inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05726032 — Phase 2
Liver Failure Research Study Groups: Empagliflozin, Placebo
Liver Failure Clinical Trial 2023: Empagliflozin 10 MG Highlights & Side Effects. Trial Name: NCT05726032 — Phase 2
Empagliflozin 10 MG (Sodium-glucose cotransporter 2 (SGLT2) inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05726032 — Phase 2
~8 spots leftby Sep 2025
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