MAINTAIN (Mucosal AblatIoN Therapy After INcretins)

Description

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.

Conditions

Obesity and Obesity-related Medical Conditions, Obesity and Overweight, Obesity Prevention, Obesity Recidivism, GLP-1, Ablation Techniques

Study Overview

Study Details

Study overview

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.

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

MAINTAIN (Mucosal AblatIoN Therapy After INcretins)

Condition
Obesity and Obesity-related Medical Conditions
Intervention / Treatment

-

Contacts and Locations

Cary

True You Weight Loss, Cary, North Carolina, United States, 27513

Cary

True You Weight Loss, Cary, North Carolina, United States, 27513

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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)

Ages Eligible for Study

21 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dr. Christopher McGowan,

Christopher McGowan, MD, MSCR, PRINCIPAL_INVESTIGATOR, True You Weight Loss

Study Record Dates

2026-06