Dr. Christopher McGowan
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.
Obesity is a multifactorial, chronic, and progressive disease of pandemic proportions. Incretin mimetics , such as semaglutide and tirzepatide, induce weight loss in adults with obesity, while also improving weight-related medical conditions, such as cardiac and renal disease. The beneficial effects on weight and metabolism require the continued presence of these medications, which have a half-life of approximately five to seven days. This concept was substantially illustrated in the STEP4 and SURMOUNT4 randomized controlled trials. In the STEP4 trial, adults with obesity were treated with sem…
Inclusion Criteria: 1. Subjects aged 21-65 2. Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≤45 kg/m² 3. Observed ≥ 10% TBWL with semaglutide or tirzepatide use for primary obesity therapy 4. Subject did not experience \>50% weight recurrence since discontinuation of semaglutide or tirzepatide 5. Maintained a stable dose of semaglutide or tirzepatide for a minimum of 12 weeks 6. Have recently discontinued or are planning to discontinue semaglutide or tirzepatide (≤ 24 weeks from last dose to time of study procedure) 7. No previous medical history of diabetes mellitus 8. Wil…
Endoscopic Gastric Fundal Mucosal Ablation (GFMA) after discontinuation of GLP-1 therapy
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