MAINTAIN (Mucosal AblatIoN Therapy After INcretins)
United States20 participantsStarted 2025-01-01
Plain-language 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.
Who can participate
Age range21 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Percent Change in Total Body Weight Loss (TBWL) from Baseline
✕. 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