Endoscopic Sleeve Gastroplasty for Obesity and Liver Disease

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

Recruiting N/A Interventional Study
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
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
132 (estimated)
Sponsor
Pichamol Jirapinyo, MD, MPH · Other
Who this trial is looking for

This trial is looking for adults with obesity and liver disease. Participants will either receive a procedure to help with weight loss or follow a diet alone.

Are You a Good Fit for This Trial?
Rules you out Type 1 diabetesActive malignancySevere coagulopathyGastroparesis

You may be able to join if

  • I am at least 18 years old
  • I have a body mass index (BMI) of 30 or higher
  • I have not changed my weight by more than 5% in the last 6 months
  • I am willing to follow the study rules and attend follow-up visits
  • I will not start any new anti-obesity medication for the next year
  • I can travel to the study site for visits
  • I can provide informed consent
  • If I am a woman who can have children, I will use birth control

You may not be able to join if

  • I have a history of chronic liver diseases like hepatitis
  • I have had foregut or gastrointestinal surgery except for a few specific cases
  • I have severe gastroesophageal reflux disease (GERD)
  • I have active smoking habits
  • I have had uncontrolled hypertension or heart disease
  • I have a severe gastrointestinal issue like Crohn's disease
  • I am currently pregnant or breastfeeding
  • I have a history of eating disorders

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting ultimate improvement in liver disease. On the other end of the spectrum, bariatric surgery has shown promise in the treatment of MASLD/metabolic dysfunction-associated ste…
Trial Locations
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Eligibility Criteria
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 c…
Contacts

Delaney Clinical Research Coordinator

617-732-5174

dmanahan@bwh.harvard.edu

CONTACT

Michele Research Manager

617-525-8266

mryan@bwh.harvard.edu

CONTACT