RESCUE: Discontinuation of GLP-1

Not yet recruiting

• Conditions: Obesity

• Registration Number: NCT07190794
• Lead Sponsor: Boston Scientific Corporation

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 loss.

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 treatment is either ESG with OverStitch™ OverStitch NXT™ or matched timeframe controls who participated in a lifestyle modification program for weight loss management.

Subjects will be enrolled in a 2:1 ratio (ESG: Lifestyle modification)

Patients are required to have the following visits for weight loss management:

* Completed initial consultation visit (baseline) prior to initiation of weight management program with documented GLP-1 history and reason for discontinuation

* Initiation of weight loss management between August 2021 and September 2024

* A minimum of two weight loss management visits, defined as performed by the physician that is managing the weight loss program and/or an affiliated weight loss specialist, completed at 1, 3, 6, or 9 months from the initiation of weight loss management

* Completed 1-year weight loss management visit (as defined above)

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-17
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-17
• Study First Posted: 2025-09-24
• Last Update Posted: 2025-09-24
• Study Start: 2025-10-01
• Primary Completion: 2026-06
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent total body weight loss (TBWL) at 1 year from baseline	12 months	The study will measure the percentage of total body weight loss for a period of one year from baseline.

Secondary Outcome Measures

Name	Time	Method
Change in body mass index (BMI)	12 months	The study will measure change in BMI for a period of one year from baseline.
Percentage of excess weight loss	12 months	The study will measure the percentage of excess weight loss for a period of one year from baseline.
Percentage of patients that achieved 5%, 10% and 15% total body weight loss	12 months	The study will measure the percentage of patients that achieved 5%, 10% and 15% total body weight loss in the one year from baseline.
Metabolic markers, if available	12 months	The study will take note of metabolic markers, if any are available.
Visit compliance and impact to responder rate	12 months	The study will examine visit compliance and impact to responder rate.
Rate of procedure-related serious adverse events within 1-year post-ESG	12 months	The study will examine the rate of procedure-related serious adverse events within 1-year post-ESG.

Trial Locations

Locations (2)

Bariendo; 🇺🇸 Miramar, Florida, United States

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States