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Endoscopic Sleeve Gastroplasty for Obesity and MASH

This study is looking at how Endoscopic Sleeve Gastroplasty (ESG) helps people with obesity and MASH (Metabolic Dysfunction-Associated Steatohepatitis), a serious liver condition. ESG is a procedure that reduces stomach size without surgery. Participants will either receive ESG plus lifestyle changes (diet and exercise) or lifestyle changes alone. The study wants to see if ESG can resolve MASH without making liver scarring worse after 12 months. You may be able to join if you are 18 or older, have a BMI of 30 or higher (or 27 with other obesity-related health issues), and your weight has been stable for 6 months. The current status of this study is unclear, and it plans to enroll 132 people.

Study design
This is an interventional study comparing two groups: one receiving Endoscopic Sleeve Gastroplasty plus lifestyle modification, and another receiving lifestyle modification alone. It plans to enroll 132 participants.
What's involved
You would need to follow protocol requirements, including signing informed consent, attending routine follow-up appointments, and completing laboratory, imaging, and other tests. The primary outcome is measured at baseline and 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 12 months to assess MASH resolution and liver fibrosis.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06138821

Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial

Recruiting
NAAges 18+InterventionalTreatment
Pichamol Jirapinyo, MD, MPH
~132 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:ESG + lifestyle modificationLifestyle modification

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
MASH resolution without worsening of liver fibrosis at 12 months
Measured over Baseline, 12 months

Conditions

Obesity
Liver Diseases
Liver Fibrosis
Liver Fat
Metabolic Dysfunction-Associated Steatotic Liver Disease
Metabolic Dysfunction-Associated Steatohepatitis
MASLD
MASH
Weight Loss
Insulin Resistance
Insulin Sensitivity
Insulin Sensitivity/Resistance
Metabolic Disease
Diabetes
Diabetes Mellitus, Type 2
NASH With Fibrosis
Non-Alcoholic Fatty Liver Disease
Non Alcoholic Fatty Liver
Non-alcoholic Steatohepatitis

Explore related trials

Nonalcoholic Fatty Liver DiseaseNonalcoholic SteatohepatitisObesityType 2 Diabetes Mellitus

NCT06138821

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Brigham and Women's Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • West Virginia University

    Morgantown, West Virginiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Pichamol Jirapinyo, MD, MPH · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Delaney Clinical Research Coordinator
[email protected]
617-732-5174
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • MASH resolution without worsening of liver fibrosis at 12 monthsBaseline, 12 months

    Comparison of endoscopic ultrasound (EUS)-guided liver biopsy results to assess MASH resolution at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.