Clinical trial

MAINTAIN (Mucosal AblatIoN Therapy After INcretins)

Recruiting now · Not applicable · 1 countries · Registry ID NCT06734312

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age21 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity and Obesity-related Medical Conditions, Obesity and Overweight, Obesity Prevention, Obesity Recidivism, GLP-1, Ablation Techniques

Full registry 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)

Treatments and study arms

Gastric Fundal Mucosal Ablation (GFMA)

Device

Endoscopic Gastric Fundal Mucosal Ablation (GFMA) after discontinuation of GLP-1 therapy

Primary outcomes

Percent Change in Total Body Weight Loss (TBWL) from Baseline12 months

Measure percent change in total body weight over time following endoscopic GFMA. TBWL = pre-op weight - post op body weight. % TBWL is the fraction of body weight expressed in percentage term

Study locations

2 locations were listed when this page was built. The first 40 are shown.

True You Weight Loss🇺🇸 Cary, North Carolina, United States
Chase Wooley, BSContact
Shannon Casey, MSContact
Christopher McGowan, MD, MSCRPrincipal Investigator
True You Weight Loss🇺🇸 Cary, North Carolina, United States
Shannon Casey, MSContact
Chase Wooley, BSContact
Christopher McGowan, MD, MSCRPrincipal Investigator