ObesityNCT07190794
RESCUE: Discontinuation of GLP-1
An observational study of Obesity, run by Boston Scientific Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- OverStitch™ or OverStitch NXT™ and Lifestyle Modification
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2025to 26 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults over 18 years of age who were prescribed GLP-1 medication for weight loss and discontinued it due to intolerance of symptoms or suboptimal weight loss.
Who may be able to join
- Adults (≥ 18 years)
- BMI ≥30 kg/m² and ≤ 50 kg/m2
- 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)
- Initiation of weight loss management no earlier than August 2021
- Completed 1-year follow-up for weight loss management (ESG and lifestyle modification or lifestyle modification alone) following initiation of weight loss treatment
- Completed at least two interim visits for weight loss management from 1, 3, 6, through 9 months following initiation of weight loss treatment
Who cannot join
- Missing data regarding GLP-1 treatment history, including weight before GLP-1 treatment and at discontinuation, and discontinuation reason
- History of GLP-1 medication for a reason other than weight management
- 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
- Had an additional endoscopic treatment performed prior to or at the time of the ESG procedure that could influence weight loss results
- 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.
- Pregnancy during the 1 year following initiation of weight loss management
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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 no earlier than August 2021
- 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)
- Conditions
- Obesity
- Being tested
- OverStitch™ or OverStitch NXT™, Lifestyle Modification
- Keywords
- GLP-1, ESG, OverStitch
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OverStitch™ or OverStitch NXT™Device
The OverStitch™ or OverStitch NXT™ Endoscopic Suturing System was used as part of each patient's ESG procedure within the routine clinical practice.
Lifestyle ModificationBehavioural
Patients participated in a lifestyle modification program for weight loss management.
| Study group | Role | What they receive |
|---|---|---|
| ESG Recipients | After discontinuing GLP-1 medication, this group elected to have an ESG procedure as a weight loss treatment. Receives: Device: OverStitch™ or OverStitch NXT™ | |
| Lifestyle Modification | After discontinuing GLP-1 medication, this group elected to participate in a structured lifestyle modification program. Receives: Behavioral: Lifestyle Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
Change in body mass index (BMI)
The study will measure change in BMI for a period of one year from baseline.
Measured: 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.
Measured: 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.
Measured: 12 months
Metabolic markers, if available
Metabolic markers include changes from baseline in the following items:
- HbA1c
- Fasting blood glucose
- Total cholesterol
- LDL
- HDL
- Triglycerides
- Blood pressure (systolic and diastolic blood pressure)
Measured: 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).
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start17 Dec 2025
- Primary completion26 May 2026
- Study completion26 May 2026
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pichamol Jirapinyo, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190794
- Sponsor's protocol ID
- E7234
- Status last verified
- Jul 2026
- First submitted
- 17 Sep 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07190794
- Acronym / sponsor ID
- E7234
- Conditions
- Obesity
- Keywords
- GLP-1, ESG, OverStitch
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 26 May 2026 (actual)
- Study completion
- 26 May 2026 (actual)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 no earlier than August 2021
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESG Recipients | – | Device: OverStitch™ or OverStitch NXT™After discontinuing GLP-1 medication, this group elected to have an ESG procedure as a weight loss treatment. |
| Lifestyle Modification | – | Behavioral: Lifestyle ModificationAfter discontinuing GLP-1 medication, this group elected to participate in a structured lifestyle modification program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults over 18 years of age who were prescribed GLP-1 medication for weight loss and discontinued it due to intolerance of symptoms or suboptimal weight loss.
Key inclusion criteria (6 listed)
- Adults (≥ 18 years)
- BMI ≥30 kg/m² and ≤ 50 kg/m2
- 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)
- Initiation of weight loss management no earlier than August 2021
- Completed 1-year follow-up for weight loss management (ESG and lifestyle modification or lifestyle modification alone) following initiation of weight loss treatment
Key exclusion criteria (6 listed)
- Missing data regarding GLP-1 treatment history, including weight before GLP-1 treatment and at discontinuation, and discontinuation reason
- History of GLP-1 medication for a reason other than weight management
- 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
- Had an additional endoscopic treatment performed prior to or at the time of the ESG procedure that could influence weight loss results
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | ESG Recipients |
| Lifestyle ModificationPatients participated in a lifestyle modification program for weight loss management. | Behavioural | Lifestyle Modification |
Primary outcome
Percent total body weight loss (TBWL) at 1 year from baseline
Time frame: 12 months
The study will measure the percentage of total body weight loss for a period of one year from baseline.
6 secondary outcomes
Change in body mass index (BMI)
Time frame: 12 months
Percentage of excess weight loss
Time frame: 12 months
Percentage of patients that achieved 5%, 10% and 15% total body weight loss
Time frame: 12 months
Metabolic markers, if available
Time frame: 12 months
Visit compliance and impact to responder rate
Time frame: 12 months
Rate of procedure-related serious adverse events within 1-year post-ESG
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pichamol Jirapinyo, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Boston Scientific Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent total body weight loss (TBWL) at 1 year from baseline (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.