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Diet or drugs? new study tests if fasting beats pills for fatty liver disease

NCT ID NCT06845345

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether a Mediterranean diet combined with intermittent fasting can reduce liver scarring (fibrosis) better than the weight-loss medication naltrexone/bupropion. About 70 adults with overweight or obesity and heart or metabolic risks (like type 2 diabetes or high blood pressure) will be followed for six months. The goal is to see if the diet approach is a safer or more effective way to manage fatty liver disease and prevent long-term liver damage.

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 70 people

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

Started

Apr 2025

Expected to finish

Jul 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 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: * BMI \> 30 kg/m2 or BMI \> 27 kg/m2 and at least one cardiometabolic risk factor (T2D, hypertension, dyslipidaemia) * Moderate to severe liver fibrosis, measured as liver stiffness by transient elastography (LSM \> 7.0 kPa and \< 13.6 kPa) * Aged 18-75 years * Written informed consent Exclusion Criteria: * An insufficient comprehension of the Dutch language (spoken and written) * Female who is pregnant, breast-feeding or intends to become pregnant * Participants with an established diagnosis of liver pathology like, but not limited to: Hepatitis B, Hepatitis C, Autoimmune hepatitis, Wilson's disease, Hemochromatosis, Primary biliary cholangitis, Primary sclerosing cholangitis, Alcoholic liver disease * History of liver transplant, or current placement on a liver transplant list * History of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy or variceal bleeding * Participants with active HIV infection and/or treatment * Participants with diagnosed malignancies with or without active treatment * Participants with history or pre-existing renal disease (eGFR \<30 mL/min/1.73 m2) * Participants with corticosteroid induced diabetes (while still using corticosteroids) * Participants using GLP-1 agonists for less than 3 months or not yet on a stable dose * Participants using MAO-inhibitors, opioids and/or methadone (due to contraindication) * Known or suspected excessive alcohol consumption (\>30 grams/day for males or \>20 grams/day for females. One drink is equivalent to 10 grams of alcohol) * Previous or planned (during the trial period) obesity treatment with surgery. However, previous interventions that, due to reversal or removal, do not have any influence on the patient's weight, in the opinion of the investigator, are allowed. * Participants with a history or evidence of any other clinically significant condition or planned or expected procedure that in the opinion of the investigator, may compromise the patient's safety or ability to complete the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Franciscus

    Rotterdam, 3045 PM, Netherlands

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