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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

• Maintained a stable dose of semaglutide or tirzepatide for a minimum of 12 weeks

• Have recently discontinued or are planning to discontinue semaglutide or tirzepatide (≤ 24 weeks from last dose to time of study procedure)

• No previous medical history of diabetes mellitus

• Willing and able to participate in the study procedures

• Understand and voluntarily sign the informed consent

Locations
United States
North Carolina
True You Weight Loss
RECRUITING
Cary
True You Weight Loss
NOT_YET_RECRUITING
Cary
Contact Information
Primary
Shannon Casey, MS
Shannon@trueyouweightloss.com
(919) 391-7843
Backup
Chase Wooley, BS
Chase@trueyouweightloss.com
(984) 345-2988
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2026-06
Participants
Target number of participants: 20
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Dr. Christopher McGowan

This content was sourced from clinicaltrials.gov