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Could a stomach tuck reverse fatty liver?

NCT ID NCT06138821

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether a minimally invasive procedure called endoscopic sleeve gastroplasty (ESG), which reduces stomach size by 70%, can help reverse fatty liver disease (MASH) in people with obesity. Researchers will compare ESG plus lifestyle changes to lifestyle changes alone in 132 participants. The main goal is to see if MASH resolves without worsening liver scarring after one year.

What this could mean

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

Active substance
endoscopic sleeve gastroplasty (a stomach-reducing procedure using an endoscopic suturing device)
What this could lead to
If it works, this could offer a less invasive alternative to surgery for treating fatty liver disease (MASH) in people with obesity.
What could go wrong
This is a relatively early trial with 132 participants, so results may not apply to everyone. The procedure carries risks like bleeding or infection, and weight regain is 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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 132 people

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

Started

Jun 2025

Expected to finish

Jun 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.

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: 1. Age ≥ 18 (male or female) 2. BMI ≥30 kg/m2 or ≥27 kg/m2 with at least one obesity-related comorbidity 3. Self-reported stable weight (no weight change \>5%) for 6 months prior to the first study visit 4. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory/imaging/additional tests, and completing diet counseling 5. Willingness to NOT start a new anti-obesity medication for the following 12 months 6. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete routine follow-up visits 7. Ability to give informed consent 8. Women of childbearing potential (i.e., not post-menopausal, nor surgically sterilized) must agree to use adequate birth control methods Exclusion Criteria: 1. Known history of other chronic liver diseases (viral hepatitis, autoimmune hepatitis, drug-induced hepatitis, and genetic) 2. Treatment with vitamin E (at doses ≥800 IU/day), pioglitazone, obeticholic acid, or resmetirom \<90 days before the first study visit 3. History of foregut or gastrointestinal (GI) surgery (except uncomplicated fundoplication, cholecystectomy or appendectomy) 4. Prior bariatric surgery 5. Prior endoscopic sleeve gastroplasty 6. Any inflammatory disease of the GI tract, including severe (LA Grade C or D) esophagitis, Barrett's esophagus with dysplasia, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease 7. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses 8. Severe gastroesophageal reflux disease (GERD) 9. A structural abnormality in the esophagus or pharynx, such as a stricture or diverticulum, that could impede passage of the endoscope. 10. Achalasia or any other severe esophageal motility disorder 11. Chronic abdominal pain 12. Gastroparesis or intractable constipation 13. Hepatic insufficiency or cirrhosis 14. Severe coagulopathy 15. Insulin-dependent diabetes (either type 1 or type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or HgbA1C ≥ 12% 16. Patients on an anti-platelet agent, anticoagulant agent or chronic/routine use of NSAIDs 17. Patients on corticosteroids, immunosuppressants, or narcotics 18. Patients on an anti-seizure or anti-arrhythmic medication 19. Patients who are pregnant or breastfeeding 20. Excessive alcohol consumption (\>20 g per day for women; \>30 g per day for men) 21. Active smoking 22. History of poorly controlled hypertension, coronary artery disease, congestive heart failure, cardiac arrhythmia 23. History of respiratory diseases such as chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer 24. History of autoimmune connective tissue disorder such as lupus, scleroderma or immunocompromised disease 25. History of active malignancy 26. History of genetic or hormonal causes for obesity, such as Prader Willi syndrome 27. History of endocrine disorders affecting weight, such as uncontrolled hypothyroidism 28. Eating disorders, including night eating syndrome, bulimia, binge eating disorder or compulsive overeating 29. Active psychological issues preventing participation in a lifestyle modification program as determined by a psychologist

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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

    2 sites. 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

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • West Virginia University

    RECRUITING

    Morgantown, West Virginia, 26506, United States

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