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RESCUE: Discontinuation of GLP-1
RESCUE: Discontinuation of GLP-1

NCT07190794

TerminatedN/A

Sponsor: Boston Scientific Corporation

Conditions: Obesity

Interventions: OverStitch™ or OverStitch NXT™, Lifestyle Modification

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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 no earlier than August 2021
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
Locations (1)
  • Miami, Florida, United States