NCT07190794

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Dec 2025Jun 2026

First Submitted

Initial submission to the registry

September 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 24, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

December 17, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

September 17, 2025

Last Update Submit

April 15, 2026

Conditions

Obesity

Keywords

GLP-1ESGOverStitch

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in body mass index (BMI)

    12 months

  • Percentage of excess weight loss

    12 months

  • Percentage of patients that achieved 5%, 10% and 15% total body weight loss

    12 months

  • Metabolic markers, if available

    12 months

  • Visit compliance and impact to responder rate

    12 months

  • +1 more secondary outcomes

Study Arms (2)

ESG Recipients

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

Device: OverStitch™ or OverStitch NXT™

Lifestyle Modification

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

Behavioral: Lifestyle Modification

Interventions

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.

ESG Recipients
Lifestyle ModificationBEHAVIORAL

Patients participated in a lifestyle modification program for weight loss management.

Lifestyle Modification

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Bariendo

Miami, Florida, 33179, United States

RECRUITING

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pichamol Jirapinyo, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Stroud

CONTACT

617-233-5845katherine.stroud@bsci.com

Pooja Goswamy

CONTACT

508-683-4335pooja.goswamy@bsci.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2025

First Posted

September 24, 2025

Study Start

December 17, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(3)