MAINTAIN (Mucosal AblatIoN Therapy After INcretins)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorDr. Christopher McGowan

About this trial

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.

Eligibility criteria

Qualifiers

Subjects 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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Gastric Fundal Mucosal Ablation (GFMA)

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Dr. Christopher McGowan

Lead sponsor

True You Weight Loss

Sponsor institution