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Diabetes drug could help stop liver damage in hepatitis b patients

NCT ID NCT05147090

Disease control Sponsor: The University of Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether empagliflozin, a diabetes drug, can prevent liver scarring (fibrosis) from getting worse in people with chronic hepatitis B. About 106 participants with moderate to severe liver scarring will take either empagliflozin or a placebo daily for three years. The main goal is to see if the drug reduces liver stiffness, a measure of scarring, using advanced imaging.

What this could mean

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

Active substance
empagliflozin
What this could lead to
If it works, this could point toward a new way to slow or stop liver scarring in people with chronic hepatitis B, even if they don't have diabetes.
What could go wrong
This is a small, early-phase trial with only 106 participants. The drug is already approved for diabetes, but its effect on liver fibrosis is unproven. Results may not apply to all patients.

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 106 people

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

Started

Jan 2022

Expected to finish

Dec 2027

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 80 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: * Patients will be recruited if they have significant/advanced fibrosis or cirrhosis confirmed by MRE Exclusion Criteria: 1. decompensated cirrhosis (variceal bleeding, ascites, hepatic hydrothorax, hepatic encephalopathy), 2. portal vein thrombosis, 3. alcohol intake \>20g within last 2 years, 4. concurrent chronic liver disease (chronic hepatitis C infection, autoimmune hepatitis, Wilson's disease, hemochromatosis, primary biliary cholangitis, drug-induced), 5. history of malignancy including hepatocellular carcinoma (HCC), 6. pregnancy, 7. contraindications to empagliflozin (estimated glomerular filtration rate (eGFR) \<45mL/min/1.73m2, recurrent genitourinary tract infections, gangrene, allergy), 8. contraindications to MRI (e.g., claustrophobia, implanted devices with ferromagnetic properties).

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection cirrhosis of liver Fibrosis fibrotic liver disease hepatitis B virus infection metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

Chronic hepatitis B Cirrhosis Empagliflozin Fibrosis, liver NAFLD SGLT2 inhibitors

Contacts and locations

Locations

  • The University of Hong Kong/Queen Mary Hospital

    Hong Kong, Hong Kong, China, 852, Hong Kong

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