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MAINTAIN (Mucosal AblatIoN Therapy After INcretins)

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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)

Study sites (2)

NC