Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT06138821 · ClinicalTrials.gov registry record · NA

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

A NA study of Obesity and Insulin Resistance, sponsored by Pichamol Jirapinyo, MD, MPH.

Recruiting
Registry status
NA
Development phase
132
Enrollment target
2
Study locations

NCT06138821: Recruiting NA study of Obesity and Insulin Resistance, sponsored by Pichamol Jirapinyo, MD, MPH.

NCT06138821 is a NA study of Obesity and Insulin Resistance that is actively recruiting participants, run by Pichamol Jirapinyo, MD, MPH. The registered enrollment target is 132 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT06138821, a NA study of Obesity and Insulin Resistance, is actively recruiting participants, sponsored by Pichamol Jirapinyo, MD, MPH.

RECRUITING
Registry status
NA
Development phase
132 participants
Enrollment target
2
Study locations

Study Summary

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 steatohepatitis (MASH) due to its efficacy in inducing weight loss. Nevertheless, its adoption has been hindered by the perceived invasiveness of surgery. Over the past decade, endoscopic sleeve gastroplasty (ESG) has gained recognition as a promising minimally-invasive approach to weight loss. The procedure involves utilizing a Food and Drug Administration (FDA)-authorized endoscopic suturing device to reduce the gastric volume by 70%. Studies reveal that ESG is associated with approximately 18.2% weight loss at one year after the procedure, with sustained results for at least 10 years. Nevertheless, the effect of ESG on MASH remains unknown. In this study, the investigators will compare ESG + lifestyle modification versus lifestyle modification alone in treating histologic MASH. The study will randomize patients to one of two different treatment options: ESG + lifestyle modification or lifestyle modification alone.

Primary Outcome

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.

Conditions Studied

Obesity Insulin Resistance Weight Loss Liver Diseases Liver Fibrosis MASLD Metabolic Dysfunction Associated Steatotic Liver Disease Metabolic Dysfunction-associated Steatohepatitis MASH Liver Fat

Interventions

  • DEVICE ESG + lifestyle modification
  • BEHAVIORAL Lifestyle modification

Study Locations (2)

Massachusetts

  • Brigham and Women's Hospital - Boston

West Virginia

  • West Virginia University - Morgantown

Trial Details

FieldValue
Enrollment Target 132 participants
Start Date 2025-06-24
Est. Completion 2028-06
Phase NA
Pichamol Jirapinyo, MD, MPH

2 total trials

What NCT06138821 shows while recruiting

NCT06138821 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (84% lower).

The record links to 10 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which ESG + lifestyle modification is the first listed.

NCT06138821 reports a single indexed study location in Massachusetts, West Virginia.

Frequently Asked Questions

What is clinical trial NCT06138821 about?

NCT06138821 is a clinical study titled "Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled 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...

What is the current status of trial NCT06138821?

This trial is currently recruiting. It is a NA study. The enrollment target is 132 participants. The study started on 2025-06-24. Estimated completion is 2028-06.

What conditions does trial NCT06138821 study?

This clinical trial studies the following conditions: Obesity, Insulin Resistance, Weight Loss, Liver Diseases, Liver Fibrosis.

What interventions are being tested in trial NCT06138821?

The interventions under investigation include: ESG + lifestyle modification (DEVICE), Lifestyle modification (BEHAVIORAL).

Who is sponsoring clinical trial NCT06138821?

This trial is sponsored by Pichamol Jirapinyo, MD, MPH, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06138821 being conducted?

This trial has 2 study locations across Massachusetts, West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Obesity

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06138821's enrollment target sits among peer trials

132 415th of 1053 higher than 638 of 1,053 other Obesity trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01766297 · 132 participants · Phase 2

    Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer

  • NCT04002947 · 132 participants · Phase 2

    Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma

  • NCT04128189 · 132 participants · Phase 3

    Shingrix in Renal Transplant Recipients

  • NCT04199780 · 132 participants · NA

    Effects of tDCS Combined With CBI on Postsurgical Pain

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

More recruiting context for NCT06138821

Source: ClinicalTrials.gov NCT06138821, the US trial registry maintained by the National Library of Medicine. NCT06138821 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.