Actively Recruiting
MAINTAIN (Mucosal AblatIoN Therapy After INcretins)
Led by Dr. Christopher McGowan · Updated on 2025-03-21
20
Participants Needed
2
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
MAINTAIN (Mucosal AblatIoN Therapy After INcretins)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 21 to 65 years
- Body mass index of 30 kg/m2 or higher, or 45 kg/m2 or higher
- Achieved at least 10% total body weight loss with semaglutide or tirzepatide
- Has not regained more than 50% of weight lost since stopping semaglutide or tirzepatide
- Maintained a stable dose of semaglutide or tirzepatide for at least 12 weeks
- Recently stopped or plans to stop semaglutide or tirzepatide within 24 weeks before study procedure
- No prior medical history of diabetes mellitus
- Willing and able to participate in study procedures
- Understands and voluntarily signs informed consent
You will not qualify if you...
- Diagnosis of type 1 or type 2 diabetes or hemoglobin A1c over 6.5% at screening
- Use of GLP-1 or GLP-1/GIP medications for diabetes treatment rather than obesity
- Use of anticoagulants, antithrombotic agents, or NSAIDs that cannot be stopped for 12 weeks
- Known bleeding disorders that cannot be medically corrected
- History of severe end-organ disease
- Unwilling to avoid incretin mimetics during the study
- Unwilling to avoid tobacco use during the study
- Taking medications or supplements that affect cholecystokinin, glucose, growth hormone, insulin, or somatostatin levels
- History of stomach surgery or manipulation unsafe for GFMA
- Active disordered eating
- Unable or unwilling to give informed consent
- Diagnosis of gastroparesis or functional dyspepsia
- Pregnant, planning pregnancy, or of child-bearing potential without approved birth control
- Active or untreated Helicobacter pylori infection
- Active gastric ulcers
- Use of medications known to cause weight loss such as liraglutide, phentermine, phentermine/topiramate, bupropion/naltrexone, or metformin
AI-Screening
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Trial Site Locations
Total: 2 locations
1
True You Weight Loss
Cary, North Carolina, United States, 27513
Not Yet Recruiting
2
True You Weight Loss
Cary, North Carolina, United States, 27513
Actively Recruiting
Research Team
S
Shannon Casey, MS
CONTACT
C
Chase Wooley, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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