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Could a diabetes drug shield the liver? new trial tests empagliflozin in cirrhosis

NCT ID NCT07322237

Disease control Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding empagliflozin (a diabetes drug) to standard carvedilol treatment can prevent liver decompensation events and death in 400 adults with cirrhosis and left ventricular diastolic dysfunction (stiff heart). Participants will receive either empagliflozin plus carvedilol or a placebo plus carvedilol for up to 2 years. The goal is to see if the combination reduces complications like bleeding, ascites, or kidney injury.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Empagliflozin and Carvedilol
What this could lead to
If it works, this combination could reduce the risk of serious liver complications and improve survival in people with cirrhosis and heart stiffness.
What could go wrong
This is a single-center Phase 4 trial, so results may not apply broadly. The drug may cause side effects like infections or low blood pressure, and the benefit over carvedilol alone is unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria * Age range of 18-65 years * Cirrhosis as diagnosed by histology or clinical laboratory and USG findings * LVDD (with EF\>50%) on 2D echocardiography with TDI * Written informed consent. Exclusion criteria * Age \>65 years * Serum Creatinine\>2 mg/dl * History of urinary tract /genital infections in last 3 months * Patient on treatment with statin (one month before the study) * Advanced Cirrhosis (MELD\>20) * Coronary artery disease * Sick sinus syndrome/ Pacemaker valvular heart disease * Cardiac rhythm disorder Peripartum cardiomyopathy * Portopulmonary hypertension/ hepatopulmonary syndrome * Transjugular intrahepatic porto systemic shunt (TIPS) insertion * Hepatocellular carcinoma * Pregnancy or lactation * Patients with HIV or retroviral therapy * Anemia Hb \< 8gm/dl in females and \< 9 gm/dl in males * Acute variceal bleeding in last 6months.

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Conditions

The condition(s) this trial relates to.

Ascites cirrhosis of liver cirrhotic cardiomyopathy diastolic heart failure Fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiometabolic risk factors Cirrhosis Cirrhotic cardiomyopathy Empagliflozin

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • PGIMER Chandigarh

    RECRUITING

    Chandigarh, 160012, India

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