MAINTAIN (Mucosal AblatIoN Therapy After INcretins)
United States20 participantsStarted 2025-01-01
Plain-language summary
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.
Who can participate
Age range
21 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change in Total Body Weight Loss (TBWL) from Baseline
. Willing and able to participate in the study procedures
Exclusion criteria
. 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