ESG versus lifestyle for people with obesity who stopped GLP-1 medicines
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
This study tests whether endoscopic sleeve gastroplasty (ESG) leads to more weight loss and similar safety than a lifestyle program for adults with obesity who stopped semaglutide or tirzepatide because of intolerance or poor response.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Scientific Corporation Industry-sponsored |
| Locations | 3 sites (Miami, Florida and 2 other locations) |
| Trial ID | NCT07190794 on ClinicalTrials.gov |
What this trial studies
This is a retrospective cohort study using medical record data from consecutively treated patients who discontinued GLP-1 therapy and then began either ESG with OverStitch/OverStitch NXT or a matched lifestyle modification program. Patients are included if they started weight-loss management no earlier than August 2021 and completed at least two interim visits plus a one-year follow-up visit. Enrollment is planned in a 2:1 ratio favoring the ESG group, and outcomes focus on weight loss over one year and safety events. The study compares weight change and adverse events between the ESG and lifestyle groups using matched timeframe controls.
Who should consider this trial
Good fit: Adults aged 18 or older with BMI 30–50 kg/m2 who discontinued semaglutide or tirzepatide for intolerance or under 5% total body weight loss after three months at a maximally tolerated dose, and who have documented initiation of a weight-loss program since August 2021 with one-year follow-up.
Not a fit: Patients who had prior bariatric surgery or other endoscopic weight-loss procedures, who used GLP-1s for non-weight reasons, or who lack complete GLP-1 treatment history are not expected to benefit from inclusion in the comparisons.
Why it matters
Potential benefit: If successful, this could provide an effective non-surgical option for people who stopped GLP-1 medicines because they couldn't tolerate them or didn't lose enough weight.
How similar studies have performed: Prior studies have shown ESG produces greater weight loss than lifestyle programs in general populations, but applying ESG specifically after GLP-1 discontinuation is a relatively novel, less-studied approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Miami, Florida and 2 other locations
- Bariendo — Miami, Florida, United States (Recruiting)
- Brigham & Women's Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- West Virginia University — Morgantown, West Virginia, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Pichamol Jirapinyo, MD, MPH — Brigham and Women's Hospital
- Study coordinator: Katherine Stroud
- Email: katherine.stroud@bsci.com
- Phone: 617-233-5845
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.