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RESCUE: Discontinuation of GLP-1 150 Lifestyle

Recruiting
Clinical Trial NCT07190794 is an observational study for Obesity that is recruiting. It started on December 17, 2025 with plans to enroll 150 participants. Led by Boston Scientific Corporation, it is expected to complete by June 1, 2026. The latest data from ClinicalTrials.gov was last updated on March 19, 2026.
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: Lifest...

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Official Title

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

Conditions
Obesity
Other Study IDs
  • E7234
NCT ID Number
NCT07190794
Start Date (Actual)
2025-12-17
Last Update Posted
2026-03-19
Completion Date (Estimated)
2026-06
Enrollment (Estimated)
150
Study Type
Observational
Status
Recruiting
Keywords
GLP-1
ESG
OverStitch
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ESG Recipients
After discontinuing GLP-1 medication, this group elected to have an ESG procedure as a weight loss treatment.
OverStitch™ 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.
Lifestyle Modification
After discontinuing GLP-1 medication, this group elected to participate in a structured lifestyle modification program.
Lifestyle Modification
Patients participated in a lifestyle modification program for weight loss management.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Percent total body weight loss (TBWL) at 1 year from baseline
The study will measure the percentage of total body weight loss for a period of one year from baseline.
12 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in body mass index (BMI)
The study will measure change in BMI for a period of one year from baseline.
12 months
Percentage of excess weight loss
The study will measure the percentage of excess weight loss for a period of one year from baseline.
12 months
Percentage of patients that achieved 5%, 10% and 15% total body weight loss
The study will measure the percentage of patients that achieved 5%, 10% and 15% total body weight loss in the one year from baseline.
12 months
Metabolic markers, if available
Metabolic markers include changes from baseline in the following items: 1. HbA1c 2. Fasting blood glucose 3. Total cholesterol 4. LDL 5. HDL 6. Triglycerides 7. Blood pressure (systolic and diastolic blood pressure)
12 months
Visit compliance and impact to responder rate
Responders are defined as \>= 10% TBWL. This analysis will analyze if responder rate improves with higher visit compliance (number of completed interactions with a provider for weight loss management).
12 months
Rate of procedure-related serious adverse events within 1-year post-ESG
The study will examine the rate of procedure-related serious adverse events within 1-year post-ESG.
12 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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

  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
Boston Scientific Corporation logoBoston Scientific Corporation136 active studies to explore
Study Central Contact
Contact: Katherine Stroud, 617-233-5845, [email protected]
Contact: Pooja Goswamy, 508-683-4335, [email protected]
3 Study Locations in 1 Countries

Florida

Bariendo, Miami, Florida, 33179, United States
Pichamol Jirapinyo, MD, MPH, Contact, 305-921-4219, [email protected]
Recruiting

Massachusetts

Brigham & Women's Hospital, Boston, Massachusetts, 02115, United States
Michele Ryan, Contact, 617-732-5500, [email protected]
Not yet recruiting

West Virginia

West Virginia University, Morgantown, West Virginia, 26506, United States
Zim Warda Hasan, Contact, 364-203-1900, [email protected]
Not yet recruiting