MAINTAIN (Mucosal AblatIoN Therapy After INcretins)

Korábbi kezelés

• Use of concomitant medications known to induce weight loss (including but not limited to liraglutide, phentermine, phentermine/topiramate, bupropion/naltrexone, metformin)

Más betegség

• Use of GLP-1 or GLP-1/GIP medication for the treatment of diabetes, rather than obesity.
• Known bleeding diathesis that cannot be corrected through medical means.
• History of decompensated end-organ disease
• History of any stomach manipulation (including repair of hiatal hernia or fundoplication) deemed unsafe by PI for GFMA
• Active H. pylori infection or history of H pylori without treatment and confirmation of eradication

Laborértékek

• Known diagnosis of type I or type II diabetes or a Hemoglobin A1c > 6.5% at time of screening
• Patients on any medications or supplements including those that may influence cholecystokinin (CCK), glucose, growth hormone, insulin and/or somatostatin levels

Egyéb

• Use of anticoagulation, antithrombotic agents, and/or NSAIDs that cannot be discontinued for a minimum of 12 weeks
• 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
• 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 gastric ulceration.

• 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