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Fatty liver drug hope: semaglutide shows promise in Long-Term study

NCT ID NCT06983171

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how well the diabetes drug semaglutide works for people with metabolic fatty liver disease (MAFLD) and liver scarring. About 70 adults will take the drug for 3 years as part of their regular care. The goal is to see if it can reduce liver fat, inflammation, and scarring, which could help prevent serious 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.

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

Sep 2028

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.

Who is studied

This study will enroll adults aged 18-70 years with obesity (BMI \>30 kg/m²) and hepatic steatosis (CAP \>238 dB/m) confirmed within 3 months. Eligible participants must have metabolic dysfunction-associated fatty liver disease (MAFLD) without other chronic liver conditions (e.g., viral hepatitis, cirrhosis complications like ascites, or MELD score \>12).

Ages

18 to 70 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: * Informed consent obtained before performing any research-related action. Research-related procedures include any procedures conducted within the framework of this study, including activities to assess eligibility criteria for participation in the study. * Body Mass Index (BMI) \> 30 kg/m². * CAP test result \> 238 dB/m based on steatometry performed no later than 3 months before the patient is included in the study. * Age 18-70 years at the time of signing the informed consent. Exclusion Criteria: * Any contraindication to the appointment of semaglutide. * Documented reasons for chronic liver disease other than non-alcoholic fatty liver disease (NAFLD). * Positive test result for HBsAg, HIV antibodies, or positive test result for HCV-RNA. * Presence of ascites, bleeding from esophageal varices, hepatic encephalopathy, spontaneous bacterial peritonitis, or liver transplantation at the time of screening or a history of these conditions. * ALT activity \> 5 times the upper limit of normal (ULN). * AST activity \> 5 times the ULN. * Alkaline phosphatase activity \> 2 times the ULN at screening. * International Normalized Ratio (INR) of prothrombin time ≥ 1.35 at screening. * MELD score \> 12 points at screening. * Platelet count less than 150,000 per microliter of blood, unless it reflects the patient's usual platelet level, and the patient does not have a diagnosis of portal hypertension in the investigator's opinion. * Treatment with GLP-1 receptor agonists within 90 days prior to the screening visit. * Treatment with hypolipidemic drugs or weight loss medications, whose dosage has not been stable, in the investigator's opinion, for 90 days prior to the screening visit. * Previous or planned (during the study period) treatment of obesity with surgical intervention or the installation of a special device for weight loss. However, the following procedures are allowed: 1. Liposuction and/or abdominoplasty, if performed more than 1 year before screening. 2. Laparoscopic gastric banding, if the band was removed more than 1 year before baseline liver biopsy and screening. 3. Intragastric balloon placement, if the balloon was removed more than 1 year before baseline liver biopsy and screening. 4. Duodenojejunal sleeve bypass, if the sleeve was removed more than 1 year before baseline liver biopsy and screening. * Presence of malignant neoplasms currently or in history within the last 5 years prior to screening. Exceptions include only basal cell or squamous cell skin cancer and any carcinoma in situ. * History of acute pancreatitis within 180 days prior to inclusion in the study. * Presence of chronic pancreatitis currently or in history. * Any of the following: myocardial infarction, stroke, heart failure of NYHA class IV, hospitalization for unstable angina, or transient ischemic attack within the last 90 days before the screening day. * Any health disorder that, in the investigator's opinion, could jeopardize patient safety or affect compliance with the protocol requirements.

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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.

Contacts and locations

Locations

  • Center of Target Therapy LLC.

    Moscow, 125008, Russia

More trials for these conditions

Other studies related to the condition(s) this trial covers.