RESCUE: Discontinuation of GLP-1

Boston Scientific

Status: Enrolling

Conditions: Obesity

Treatments: Behavioral: Lifestyle Modification; Device: OverStitch™ or OverStitch NXT™

Study type: Observational

Funder types: Industry

Identifiers

NCT07190794

E7234

Details and patient eligibility

About

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.

Full 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)

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

ESG Recipients

Description:

After discontinuing GLP-1 medication, this group elected to have an ESG procedure as a weight loss treatment.

Treatment:

Device: OverStitch™ or OverStitch NXT™

Lifestyle Modification

Description:

After discontinuing GLP-1 medication, this group elected to participate in a structured lifestyle modification program.

Treatment:

Behavioral: Lifestyle Modification