Gastric ablation therapy for weight management after stopping GLP-1 medications

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

This study tests if a procedure called gastric ablation can help adults keep off weight they lost with GLP-1 medications after they stop taking them.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: True You Weight Loss (other)
• Locations: 2 sites (Cary, North Carolina and 1 other locations)
• Trial ID: NCT06734312 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of gastric fundal mucosal ablation (GFMA) on weight maintenance in adults who have lost over 10% of their body weight using GLP-1 medications like semaglutide or tirzepatide. Participants will undergo GFMA after planning to discontinue these medications, which are known to aid in weight loss but often lead to weight regain upon cessation. The study aims to determine if GFMA can help sustain weight loss and improve obesity-related health outcomes. The approach is based on previous findings that highlight the challenges of maintaining weight loss without ongoing medication.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21-65 with a BMI between 30 and 45 who have lost at least 10% of their body weight using GLP-1 therapy.

Not a fit: Patients with a history of diabetes or those who have not experienced significant weight loss with GLP-1 medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could help patients maintain their weight loss and improve their overall health after stopping GLP-1 medications.

How similar studies have performed: While similar approaches have been explored, this specific intervention of GFMA following GLP-1 therapy discontinuation is novel and has not been extensively tested.

Eligibility 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)

Where this trial is running

Cary, North Carolina and 1 other locations

• True You Weight Loss — Cary, North Carolina, United States (NOT_YET_RECRUITING)
• True You Weight Loss — Cary, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Christopher McGowan, MD, MSCR — True You Weight Loss
• Study coordinator: Shannon Casey, MS

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