RecruitingNot Applicable

RESCUE: Discontinuation of GLP-1

United States150 participantsStarted 2025-12-17

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 no earlier than August 2021
✓. 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 criteria

✕. 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

What they're measuring

Percent total body weight loss (TBWL) at 1 year from baseline

Timeframe: 12 months

Trial details

NCT IDNCT07190794

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-06

Contact for this trial

Katherine Stroud

617-233-5845 katherine.stroud@bsci.com

View on ClinicalTrials.gov More Obesity trials