Recruiting

Mucosal Ablation

Sponsor:

Dr. Christopher McGowan

Code:

NCT06734312

Conditions

Obesity and Obesity-related Medical Conditions

Obesity and Overweight

Obesity Prevention

Obesity Recidivism

GLP-1

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Gastric Fundal Mucosal Ablation (GFMA)

Study Details

Brief 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.

Conditions

Obesity and Obesity-related Medical Conditions

Obesity and Overweight

Obesity Prevention

Obesity Recidivism

GLP-1

Study ID

NCT06734312

Start date

Jan 1, 2025

Status verified date

Jan, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Gastric Fundal Mucosal Ablation (GFMA) following discontinuation of GLP-1 therapy

Subjects will undergo endoscopic Gastric Fundal Mucosal Ablation (GFMA) following following discontinuation of GLP-1 therapy. This will be performed by an experienced endoscopist specialized in bariatric endoscopy in a single endoscopic session.

Interventions

Gastric Fundal Mucosal Ablation (GFMA)

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

Primary outcome measure

  • Percent Change in Total Body Weight Loss (TBWL) from Baseline [ Time Frame: 12 months ]

Central Contacts and Locations

Locations

True You Weight Loss

Recruiting

Cary, North Carolina, United States, 27513

Contacts

Principal Investigator:

Christopher McGowan, MD, MSCR

More Information

Sponsor

Dr. Christopher McGowan

Last update posted

Mar 21, 2025

Last verified

Jan, 2025

Keywords

  • obesity
  • obesity and overweight
  • endoscopic bariatric therapy
  • ablation
  • gastric mucosal ablation
  • GMA
  • GFMA
  • glp-1
  • weight loss medications
  • weight loss
  • semaglutide
  • tirzepatide
  • hunger
  • appetite

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Dr. Christopher McGowan on 2025-03-21.