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Diabetes drugs may reverse fatty liver damage in new trial

NCT ID NCT04639414

Disease control Sponsor: German Diabetes Center 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This study tests whether combining two diabetes drugs—semaglutide and empagliflozin—can reverse liver damage from NASH (a severe form of fatty liver disease) in people with type 2 diabetes. Participants will receive either the combo, empagliflozin alone, or a placebo for 48 weeks. The main goal is to see if the treatment clears NASH without worsening liver scarring.

What this could mean

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

Active substance
Semaglutide and empagliflozin
What this could lead to
If successful, this combination could offer a new way to treat NASH in people with type 2 diabetes, potentially reversing liver damage and reducing the need for separate medications.
What could go wrong
This is a Phase 4 trial, but NASH is a complex disease and previous treatments have failed. The drugs may not improve liver health, and side effects like gastrointestinal issues or hypoglycemia are possible.

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

192 people

The number who actually took part.

Started

Mar 2021

Finished

Nov 2025

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

25 to 75 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: * Diagnosis of T2D and NASH with fibrosis stage F1-F3 * Age between 25 and 75 years * HbA1c ≤ 9.5% * obtained written informed consent Exclusion Criteria: * Contraindications on liver biopsy * Evidence of cirrhosis on liver biopsy * Liver disease of other etiology including chronic viral hepatitis (B or C), alcohol abuse, hemochromatosis, alpha-1 antitrypsin deficiency, autoimmune hepatitis, Wilson's disease, primary sclerosing cholangitis or primary biliary cirrhosis, or liver cirrhosis of any etiology * History of ketoacidosis * Alcohol consumption \>30 g/d for males and \>20 g/d for females * Past (≥5 years) or current history of alcohol or drug abuse and/or psychiatric disease including severe depression necessitating pharmacological treatment * Medications that may induce steatosis:tamoxifen, raloxifene, oral glucocorticoids or chloroquine * Planned pregnancy, pregnant or lactating women, positive pregnancy test, and woman of childbearing potential not using two adequate methods of contraception, including a barrier method and a highly efficacious non-barrier method

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Conditions

The condition(s) this trial relates to.

diabetes mellitus fatty liver disease metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease type 2 diabetes mellitus

As listed by the trial registrant

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

Non-alcoholic fatty liver disease (NAFLD) Non-alcoholic steatohepatitis (NASH) Type 2 diabetes

Contacts and locations

Locations

  • Eugastro GmbH

    Leipzig, 04103, Germany

  • Franziskus-Krankenhaus Berlin

    Berlin, 10787, Germany

  • German Diabetes Center

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen, 32545, Germany

  • Leber- und Studienzentrum Checkpoint

    Berlin, 10961, Germany

  • Medizinische Universität Graz

    Graz, 8010, Austria

  • Medizinische Universität Innsbruck

    Innsbruck, Austria

  • Medizinische Universität Wien

    Vienna, Austria

  • Städtisches Klinikum Brandenburg GmbH

    Brandenburg, 14770, Germany

  • Städtisches Klinikum Braunschweig gGmbH

    Braunschweig, 38126, Germany

  • TUM

    München, 81675, Germany

  • University Clinics Berlin Charité

    Berlin, 12200, Germany

  • University Clinics Berlin Charité

    Berlin, 13353, Germany

  • University Clinics Bochum

    Bochum, 44892, Germany

  • University Clinics Carl Gustav Carus Dresden

    Dresden, 01307, Germany

  • University Clinics Essen

    Essen, 45147, Germany

  • University Clinics Frankfurt

    Frankfurt, 60590, Germany

  • University Clinics Freiburg

    Freiburg im Breisgau, 79106, Germany

  • University Clinics Heidelberg

    Heidelberg, 69120, Germany

  • University Clinics Johannes-Gutenberg Mainz

    Mainz, 55131, Germany

  • University Clinics Tübingen

    Tübingen, 72076, Germany

  • University Clinics Würzburg

    Würzburg, 97080, Germany

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Wiener Gesundheitsverbund, Klinik Hietzing

    Vienna, Austria

  • Wiener Gesundheitsverbund, Klinik Landstraße

    Vienna, 1030, Austria

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