MAINTAIN (Mucosal AblatIoN Therapy After INcretins)
Recruiting now · Not applicable
Conditions studied: Obesity and Obesity-related Medical Conditions, Obesity and Overweight, Obesity Prevention, Obesity Recidivism, GLP-1, Ablation Techniques
In brief
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.
Key facts
- Study ID
- NCT06734312
- Run by
- Dr. Christopher McGowan
- People needed
- 20
- Starts
- 2025-01-01
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2025-03-21
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
- History of decompensated end-organ disease
- 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
- History of any stomach manipulation (including repair of hiatal hernia or fundoplication) deemed unsafe by PI for GFMA
- 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 H. pylori infection or history of H pylori without treatment and confirmation of eradication
- Active gastric ulceration.
- Use of concomitant medications known to induce weight loss (including but not limited to liraglutide, phentermine, phentermine/topiramate, bupropion/naltrexone, metformin)
Where it is running
- True You Weight Loss — Cary, North Carolina, United States (enrolling)
- True You Weight Loss — Cary, North Carolina, United States
Full record on ClinicalTrials.gov
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