RecruitingNCT07190794

RESCUE: Discontinuation of GLP-1

Evaluation of Endoscopic Sleeve Gastroplasty (ESG) as an Alternative Weight Loss Strategy for Patients With Obesity Discontinuing GLP-1 Receptor Agonists Due to Intolerance or Ineffectiveness: A Retrospective Study


Sponsor

Boston Scientific Corporation

Enrollment

150 participants

Start Date

Dec 17, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria6

  • 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

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Interventions

DEVICEOverStitch™ or OverStitch NXT™

The OverStitch™ or OverStitch NXT™ Endoscopic Suturing System was used as part of each patient's ESG procedure within the routine clinical practice.

BEHAVIORALLifestyle Modification

Patients participated in a lifestyle modification program for weight loss management.


Locations(3)

Bariendo

Miami, Florida, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

West Virginia University

Morgantown, West Virginia, United States

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NCT07190794


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