MAINTAIN (Mucosal AblatIoN Therapy After INcretins)
Gastric Fundal Mucosal Ablation for Weight Management in Patients Stopping Glucagon-like Peptide-1 Receptor Agonists
Dr. Christopher McGowan
20 participants
Jan 1, 2025
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
Inclusion Criteria9
- Subjects aged 21-65
- Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≤45 kg/m²
- Observed ≥ 10% TBWL with semaglutide or tirzepatide use for primary obesity therapy
- Subject did not experience \>50% weight recurrence since discontinuation of semaglutide or tirzepatide
- Maintained a stable dose of semaglutide or tirzepatide for a minimum of 12 weeks
- Have recently discontinued or are planning to discontinue semaglutide or tirzepatide (≤ 24 weeks from last dose to time of study procedure)
- No previous medical history of diabetes mellitus
- Willing and able to participate in the study procedures
- Understand and voluntarily sign the informed consent
Exclusion Criteria16
- Known diagnosis of type I or type II diabetes or a Hemoglobin A1c \> 6.5% at time of screening
- Use of GLP-1 or GLP-1/GIP medication for the treatment of diabetes, rather than obesity.
- Use of anticoagulation, antithrombotic agents, and/or NSAIDs that cannot be discontinued for a minimum of 12 weeks
- Known bleeding diathesis that cannot be corrected through medical means.
- History of decompensated end-organ disease
- Unwillingness to abstain from the use of incretin mimetics during the study duration.
- Unwillingness to abstain from the use of tobacco during the study duration
- Patients on any medications or supplements including those that may influence cholecystokinin (CCK), glucose, growth hormone, insulin and/or somatostatin levels
- History of any stomach manipulation (including repair of hiatal hernia or fundoplication) deemed unsafe by PI for GFMA
- Active disordered eating
- Patients who do not give their consent to the enrollment in the study or are incompetent, unconscious or unable to express their consent for any reason
- Known diagnosis of gastroparesis or functional dyspepsia
- Patients who are pregnant, who plan to become pregnant during study duration, or patients of child-bearing potential who refuse effective birth control methods (as approved by PI)
- Active H. pylori infection or history of H pylori without treatment and confirmation of eradication
- Active gastric ulceration.
- Use of concomitant medications known to induce weight loss (including but not limited to liraglutide, phentermine, phentermine/topiramate, bupropion/naltrexone, metformin)
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Interventions
Endoscopic Gastric Fundal Mucosal Ablation (GFMA) after discontinuation of GLP-1 therapy
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06734312