About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Gastric Fundal Mucosal Ablation (GFMA)
Treatment groups
Sponsors and collaborators
Dr. Christopher McGowan
Lead sponsor
True You Weight Loss
Sponsor institution