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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2025-06-24 |
| Est. Completion | 2028-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06138821
The ClinicalTrials.gov registry entry for NCT06138821 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (84% lower). The listed sponsor is Pichamol Jirapinyo, MD, MPH, which has 2 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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