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RESCUE: Discontinuation of GLP-1

RECRUITINGSponsored by Boston Scientific Corporation
Actively Recruiting
SponsorBoston Scientific Corporation
Started2025-12-17
Est. completion2026-06
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations3 sites

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 loss.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

1. Adults (≥ 18 years)
2. BMI ≥30 kg/m² and ≤ 50 kg/m2
3. 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)
4. Initiation of weight loss management between August 2021 and September 2024
5. Completed 1-year follow-up for weight loss management (ESG and lifestyle modification or lifestyle modification alone) following initiation of weight loss treatment
6. Completed at least two interim visits for weight loss management from 1, 3, 6, through 9 months following initiation of weight loss treatment

Exclusion Criteria:

1. Missing data regarding GLP-1 treatment history, including weight before GLP-1 treatment and at discontinuation, and discontinuation reason
2. History of GLP-1 medication for a reason other than weight management
3. 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
4. Had an additional endoscopic treatment performed prior to or at the time of the ESG procedure that could influence weight loss results
5. 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.
6. Pregnancy during the 1 year following initiation of weight loss management

Conditions2

ObesityWeight Loss

Locations3 sites

Florida

1 site
Bariendo
Miami, Florida, 33179
Pichamol Jirapinyo, MD, MPH305-921-4219pjirapinyo@bariendo.com

Massachusetts

1 site
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Michele Ryan617-732-5500mryan@bwh.harvard.edu

West Virginia

1 site
West Virginia University
Morgantown, West Virginia, 26506
Zim Warda Hasan364-203-1900zh00027@mix.wvu.edu

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