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.
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
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.
Single group
Gastric Fundal Mucosal Ablation (GFMA)
DeviceEndoscopic Gastric Fundal Mucosal Ablation (GFMA) after discontinuation of GLP-1 therapy
Percent Change in Total Body Weight Loss (TBWL) from Baseline
Measure percent change in total body weight over time following endoscopic GFMA. TBWL = pre-op weight - post op body weight. % TBWL is the fraction of body weight expressed in percentage term
Rate of Adverse Events (AE)
Occurrence of Adverse Events along with AE Type, severity, and relationship to treatment.
Quality of Life Assessment
Baseline quality of life assessment scores compared to follow-up quality of life assessment scores. Quality of life score assessed and measured by the Impact of Weight on Quality of Life-Lite questionnaire. Scoring for the questionnaire ranges from 0 (minimum) to 100 (maximum). Higher scores for the Impact of Weight on Quality of Life-lite questionnaire indicates higher quality of life.
Quality of Life Assessment
Baseline quality of life assessment scores compared to follow-up quality of life assessment scores. Quality of life score assessed and measured by the 36-Item Short Form Survey. Scoring for the questionnaire ranges from 0 (minimum) to 100 (maximum). Higher scores on the 36-Item Short Form Survey questionnaire indicates higher quality of life.
Appetite and Hunger Assessment
Baseline appetite and hunger assessment scores compared to follow-up appetite and hunger assessment scores. Appetite and hunger assessed and measured by the DAILY EATS questionnaire, which contains a numerical rating scale of 0-10 for each its 5 items. A higher score indicates greater hunger and appetite. A reduction in DAILY EATS score from baseline indicates a decrease in hunger and appetite levels, which is considered a positive outcome.
Click on the lead sponsor to view all of their trials.
Dr. Christopher McGowan
Lead sponsor
True You Weight Loss
Sponsor institution
