Gastric mucosal devitalization is safe and effective in reducing body weight and visceral adiposity in a porcine model.
Vivek Kumbhari, Stefanie Lehmann, Nadine Schlichting...
https://pubmed.ncbi.nlm.nih.gov/29476845Actively Recruiting
Phase Not Applicable
Age: 21Years - 65Years
All Genders
ID06734312
Gastric Fundal Mucosal Ablation for Weight Management in Patients Stopping Glucagon-like Peptide-1 Receptor Agonists
Led by Dr. Christopher McGowan · Updated on 2025-03-21
20
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the effects of gastric fundal mucosal ablation (GFMA) on weight changes in adults with obesity who have previously lost more than 10% of their body weight using GLP-1 medications like semaglutide or tirzepatide and are planning to stop these medications. Obesity is a complex and ongoing condition affecting many people, and while incretin mimetics help with weight loss and related health issues, their benefits tend to fade when the medication is stopped. This study aims to explore whether GFMA can help maintain weight loss after stopping these drugs. Participants will undergo a single endoscopic procedure called GFMA, which uses hybrid argon plasma coagulation to treat the lining of the stomach's fundus. This treatment is designed to reduce hunger by lowering levels of the hunger hormone ghrelin and making the stomach less stretchy, helping control appetite. The procedure will be done after participants have discontinued their GLP-1 therapy. During the study, researchers will monitor participants' weight changes over 12 months, focusing on the percentage of total body weight lost from the start. They will also assess quality of life, hunger and appetite levels, eating behavior, and any adverse events at multiple points throughout the year. Participants will have regular evaluations to track body mass index, weight recurrence, and their confidence in managing eating and weight.
CONDITIONS
Brief Title
MAINTAIN (Mucosal AblatIoN Therapy After INcretins)
Who Can Participate
Age: 21Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Subjects aged 21 to 65 years
- Body Mass Index (BMI) of 30 kg/m² or higher, or 45 kg/m² or higher
- Achieved at least 10% total body weight loss with semaglutide or tirzepatide for obesity therapy
- Did not experience more than 50% weight regain since stopping semaglutide or tirzepatide
- Maintained a stable dose of semaglutide or tirzepatide for at least 12 weeks
- Recently stopped or plan to stop semaglutide or tirzepatide within 24 weeks before study procedure
- No history of diabetes mellitus
- Willing and able to participate in study procedures
- Understand and voluntarily sign the informed consent
You will not qualify if you...
- Diagnosis of type I or type II diabetes or Hemoglobin A1c greater than 6.5% at screening
- Use of GLP-1 or GLP-1/GIP medications for diabetes treatment instead of obesity
- Use of anticoagulant, antithrombotic, or NSAID medications that cannot be stopped for at least 12 weeks
- Known bleeding disorders that cannot be medically corrected
- History of severe end-organ disease
- Unwilling to stop incretin mimetics during the study
- Unwilling to abstain from tobacco use during the study
- Use of medications or supplements affecting certain hormones like cholecystokinin, glucose, growth hormone, insulin, or somatostatin
- 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 effective birth control
- Active Helicobacter pylori infection or untreated history without confirmed eradication
- Active gastric ulcers
- Use of other weight loss medications such as liraglutide, phentermine, or metformin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Single session
Participants undergo a single endoscopic session for Gastric Fundal Mucosal Ablation (GFMA) following discontinuation of GLP-1 therapy.
1 visit (in-person)
Long-term Monitoring
Duration - 12 months
Participants are monitored for weight loss, adverse events, quality of life, appetite, and other health assessments for up to 12 months following the procedure.
Visits at Month 1, 2, 3, 6, 7, 8, 9, 10, 11, and 12
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
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Research Team
S
Shannon Casey, MS
C
Chase Wooley, BS
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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Published Research Related To This Trial
Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension.
John P H Wilding, Rachel L Batterham, Melanie Davies...
https://pubmed.ncbi.nlm.nih.gov/35441470Emerging Role of GLP-1 Agonists in Obesity: A Comprehensive Review of Randomised Controlled Trials.
Mihaela-Simona Popoviciu, Lorena Păduraru, Galal Yahya...
https://pubmed.ncbi.nlm.nih.gov/37445623