RecruitingNot ApplicableNCT06734312

MAINTAIN (Mucosal AblatIoN Therapy After INcretins)

Gastric Fundal Mucosal Ablation for Weight Management in Patients Stopping Glucagon-like Peptide-1 Receptor Agonists


Sponsor

Dr. Christopher McGowan

Enrollment

20 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to assess the effect of gastric fundal mucosal ablation (GFMA) on weight trajectory following discontinuation of once-weekly semaglutide or tirzepatide in adults with obesity. In this study, GFMA will be performed on patients who have experienced \> 10% weight loss with GLP-1 therapy and who plan to discontinue use of GLP-1 medications for the duration of the study.


Eligibility

Min Age: 21 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether gastric fundal mucosal ablation (GFMA) — an endoscopic procedure that uses a controlled burn to destroy hunger-hormone-producing cells in the stomach lining — can help people maintain weight loss after stopping GLP-1 receptor agonist medications (such as semaglutide or tirzepatide), which are widely used for obesity but cause significant weight regain when discontinued. The procedure aims to reduce the hunger hormone ghrelin and make the stomach feel fuller sooner, mimicking some of the appetite-suppressing effects of the medication. Adults aged 21–65 with a BMI of 30–45 who lost at least 10% of their body weight on semaglutide or tirzepatide, have recently stopped or plan to stop the medication, and have no history of diabetes are eligible. Participation involves undergoing the GFMA procedure under standard endoscopy and completing weight, appetite, and quality-of-life assessments at follow-up visits over the study duration. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEGastric Fundal Mucosal Ablation (GFMA)

Endoscopic Gastric Fundal Mucosal Ablation (GFMA) after discontinuation of GLP-1 therapy


Locations(2)

True You Weight Loss

Cary, North Carolina, United States

True You Weight Loss

Cary, North Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06734312


Related Trials