Status:
RECRUITING
RESCUE: Discontinuation of GLP-1
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Brief Summary
This study is designed to compare weight loss outcomes and safety of ESG versus lifestyle modification in patients with obesity who discontinued GLP-1 therapy due to intolerance or suboptimal weight l...
Detailed Description
This retrospective cohort study includes collection of data from medical records for consecutively treated patients undergoing treatment for weight loss following GLP-1 discontinuation. Weight loss tr...
Eligibility Criteria
Inclusion
- Adults (≥ 18 years)
- BMI ≥30 kg/m² and ≤ 50 kg/m2
- Discontinued GLP-1 therapy for weight loss (semaglutide and tirzepatide only) for intolerance or suboptimal weight loss (\<5% TBWL after 3 months at maximally tolerated dose)
- Initiation of weight loss management between August 2021 and September 2024
- Completed 1-year follow-up for weight loss management (ESG and lifestyle modification or lifestyle modification alone) following initiation of weight loss treatment
- Completed at least two interim visits for weight loss management from 1, 3, 6, through 9 months following initiation of weight loss treatment
Exclusion
- Missing data regarding GLP-1 treatment history, including weight before GLP-1 treatment and at discontinuation, and discontinuation reason
- History of GLP-1 medication for a reason other than weight management
- Had bariatric surgery or an endoscopic procedure for weight loss treatment other than ESG with OverStitch™ or OverStitch NXT™ within 1 year of starting weight loss management
- Had an additional endoscopic treatment performed prior to or at the time of the ESG procedure that could influence weight loss results
- Had another weight loss treatment during the 1-year follow-up reported during this study. Weight loss treatment includes but is not limited to appetite suppressants, anti-obesity medications, plastic surgery or body contouring procedures.
- Pregnancy during the 1 year following initiation of weight loss management
Key Trial Info
Start Date :
December 17 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07190794
Start Date
December 17 2025
End Date
June 1 2026
Last Update
December 26 2025
Active Locations (3)
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1
Bariendo
Miami, Florida, United States, 33179
2
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
3
West Virginia University
Morgantown, West Virginia, United States, 26506