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New treatment option for Obesity and Obesity-related Medical Conditions
Official title MAINTAIN (Mucosal AblatIoN Therapy After INcretins)
ClinicalTrials.gov ID: NCT06734312
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65
You may be able to join if
- people 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
You likely can't join 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.
See the full eligibility criteria
- people 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Cary, North Carolina, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cary, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.