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MAINTAIN (Mucosal AblatIoN Therapy After INcretins)

Recruiting

Gastric Fundal Mucosal Ablation for Weight Management in Patients Stopping Glucagon-like Peptide-1 Receptor Agonists

Who can join

Ages 21 to 65 · All sexes

Full eligibility criteria
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. Willing and able to participate in the study procedures
9. Understand and voluntarily sign the informed consent

Exclusion Criteria:

1. Known diagnosis of type I or type II diabetes or a Hemoglobin A1c \> 6.5% at time of screening
2. Use of GLP-1 or GLP-1/GIP medication for the treatment of diabetes, rather than obesity.
3. Use of anticoagulation, antithrombotic agents, and/or NSAIDs that cannot be discontinued for a minimum of 12 weeks
4. Known bleeding diathesis that cannot be corrected through medical means.
5. History of decompensated end-organ disease
6. Unwillingness to abstain from the use of incretin mimetics during the study duration.
7. Unwillingness to abstain from the use of tobacco during the study duration
8. Patients on any medications or supplements including those that may influence cholecystokinin (CCK), glucose, growth hormone, insulin and/or somatostatin levels
9. History of any stomach manipulation (including repair of hiatal hernia or fundoplication) deemed unsafe by PI for GFMA
10. Active disordered eating
11. 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
12. Known diagnosis of gastroparesis or functional dyspepsia
13. 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)
14. Active H. pylori infection or history of H pylori without treatment and confirmation of eradication
15. Active gastric ulceration.
16. Use of concomitant medications known to induce weight loss (including but not limited to liraglutide, phentermine, phentermine/topiramate, bupropion/naltrexone, metformin)

About the study

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.

What is being tested

Sponsor: Dr. Christopher McGowan · Participants: 20 · Started: Jan 1, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06734312

Locations in the U.S.

North CarolinaTrue You Weight Loss, Cary (Not yet recruiting)
True You Weight Loss, Cary

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.