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New hope for weight loss after GLP-1 failure: Stomach-Sewing procedure tested

NCT ID NCT07190794

Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 24, 2026 · Updated 4 times

Summary

This study looked at whether a procedure called endoscopic sleeve gastroplasty (ESG) could help people with obesity who stopped taking GLP-1 weight loss drugs because of side effects or poor results. Researchers compared weight loss and safety in 18 adults who either had ESG plus lifestyle changes or just lifestyle changes alone. The goal was to see if ESG offers a good alternative for those who cannot use GLP-1 medications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Endoscopic sleeve gastroplasty (ESG) using the OverStitch or OverStitch NXT suturing system, plus lifestyle modification
What this could lead to
If successful, this could show that ESG is a safe and effective weight loss option for people who cannot tolerate or do not respond well to GLP-1 medications.
What could go wrong
This was a small, terminated study with only 18 participants, so results may not be reliable or apply to a broader population. ESG is a procedure with its own risks, such as infection or bleeding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

18 people

The number who actually took part.

Started

Dec 2025

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity

Contacts and locations

Locations

  • Bariendo

    Miami, Florida, 33179, United States

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