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Diabetes drug may ease dangerous fluid retention in liver disease

NCT ID NCT07684326

Disease control Sponsor: Beni-Suef University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study tests whether dapagliflozin, a drug originally for diabetes, can help people with liver cirrhosis who have ascites (fluid buildup in the belly). The goal is to see if it reduces the need for fluid drainage procedures, lowers hospital stays, and improves quality of life. The trial includes 52 adults with cirrhosis and ascites, comparing dapagliflozin against standard care over three months.

What this could mean

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

Active substance
dapagliflozin
What this could lead to
If it works, this could offer a new way to manage ascites and reduce hospital visits for people with advanced liver disease.
What could go wrong
This is an early combined Phase 2/3 trial with only 52 participants, so results may not apply broadly. Dapagliflozin can cause side effects like dehydration or low blood pressure.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 52 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Sep 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 years and older

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: * Adult patients 18 years of age and older with a diagnosis of liver cirrhosis with any degree of ascites that led to previous or recent hospital admission (determined by clinical findings and imaging) will be included in the study. Exclusion Criteria: 1. Child Pugh score ≥ 12 or MELD score \> 25. 2. Previous history of hypoglycemia or has a previous history of DKA. 3. Blood pressure less than 90/60 or need dose of midodrine \>15 mg/day. 4. Previous history of recurrent urinary tract infections (more than 2 infections in the last 6 months) or anatomic urologic defects that predispose to urinary tract infection. 5. Pregnant or lactating female patients. 6. Hypersensitivity to dapagliflozin. 7. eGFR \< 30 ml/min/1.73 m2 8. Had hepatocellular carcinoma or any malignancy. 9. Serum sodium level \< 125 mg/dl. 10. Portal vein thrombosis.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver

As listed by the trial registrant

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

Ascites hepatic

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

  • Haram Hospital

    RECRUITING

    Giza, 12556, Egypt

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