MAINTAIN (Mucosal AblatIoN Therapy After INcretins) (MAINTAIN)

March 18, 2025 updated by: Dr. Christopher McGowan

Gastric Fundal Mucosal Ablation for Weight Management in Patients Stopping Glucagon-like Peptide-1 Receptor Agonists

The purpose of this study is to assess the effect of gastric fundal mucosal ablation (GFMA) on weight trajectory following discontinuation of once-weekly semaglutide or tirzepatide in adults with obesity. In this study, GFMA will be performed on patients who have experienced > 10% weight loss with GLP-1 therapy and who plan to discontinue use of GLP-1 medications for the duration of the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Obesity is a multifactorial, chronic, and progressive disease of pandemic proportions. Incretin mimetics , such as semaglutide and tirzepatide, induce weight loss in adults with obesity, while also improving weight-related medical conditions, such as cardiac and renal disease. The beneficial effects on weight and metabolism require the continued presence of these medications, which have a half-life of approximately five to seven days. This concept was substantially illustrated in the STEP4 and SURMOUNT4 randomized controlled trials. In the STEP4 trial, adults with obesity were treated with semaglutide for a 20-week run-in, losing 10.6% of body weight, thereafter randomized 2:1 to continued semaglutide use vs placebo. Over the subsequent 48 weeks, the semaglutide arm lost an additional 7.9% of original body weight, whereas the placebo arm saw two-thirds the lost weight return. In the SURMOUNT-4 trial, adults with obesity were treated with tirzepatide for a 36-week run-in period, losing 20.9% of body weight, thereafter, randomized 1:1 for continued treatment or placebo. Over the subsequent 52 weeks, the treatment arm lost an additional 5.5% of body weight, whereas the placebo arm saw a return of approximately half the weight that had been lost. These observations present challenges for long-term obesity management when confronted by multiple reports showing high rates of discontinuation of incretin mimetics soon after initiation. These observations present challenges for long-term obesity management when confronted by multiple reports showing high rates of discontinuation of incretin mimetics soon after initiation. Gastric fundal mucosal ablation (GFMA) is a novel endoscopic approach to control appetite which uses hybrid argon plasma coagulation (HybridAPC) to ablate the superficial tissue of the gastric fundus to induce cell death and fibrotic remodeling. In an early safety and feasibility study of ten adults with obesity, GFMA reduced circulating levels of the only known hunger hormone in humans, ghrelin. This led to a measured suppression of inter-meal hunger and cravings, as well as improved confidence in the ability to resist cravings. In addition to reducing ghrelin-producing cell population within the fundus, GFMA induced significant fundal fibrin deposition. This resulted in a stiffer, less compliant fundus, reducing maximum tolerated volume of a standardized nutrient drink test, enhancing intra-meal satiation. Given that GFMA induces appetite control through both visceroceptive and hormonal mechanism, much like incretin mimetics, we hypothesize that GFMA can prevent or limit weight recurrence in adults who have stopped these medications after successful obesity treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Cary, North Carolina, United States, 27513
      • Cary, North Carolina, United States, 27513

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects aged 21-65
  2. Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≤45 kg/m²
  3. Observed ≥ 10% TBWL with semaglutide or tirzepatide use for primary obesity therapy
  4. Subject did not experience >50% weight recurrence since discontinuation of semaglutide or tirzepatide
  5. Maintained a stable dose of semaglutide or tirzepatide for a minimum of 12 weeks
  6. Have recently discontinued or are planning to discontinue semaglutide or tirzepatide (≤ 24 weeks from last dose to time of study procedure)
  7. No previous medical history of diabetes mellitus
  8. Willing and able to participate in the study procedures
  9. Understand and voluntarily sign the informed consent

Exclusion Criteria:

  1. Known diagnosis of type I or type II diabetes or a Hemoglobin A1c > 6.5% at time of screening
  2. Use of GLP-1 or GLP-1/GIP medication for the treatment of diabetes, rather than obesity.
  3. Use of anticoagulation, antithrombotic agents, and/or NSAIDs that cannot be discontinued for a minimum of 12 weeks
  4. Known bleeding diathesis that cannot be corrected through medical means.
  5. History of decompensated end-organ disease
  6. Unwillingness to abstain from the use of incretin mimetics during the study duration.
  7. Unwillingness to abstain from the use of tobacco during the study duration
  8. Patients on any medications or supplements including those that may influence cholecystokinin (CCK), glucose, growth hormone, insulin and/or somatostatin levels
  9. History of any stomach manipulation (including repair of hiatal hernia or fundoplication) deemed unsafe by PI for GFMA
  10. Active disordered eating
  11. Patients who do not give their consent to the enrollment in the study or are incompetent, unconscious or unable to express their consent for any reason
  12. Known diagnosis of gastroparesis or functional dyspepsia
  13. Patients who are pregnant, who plan to become pregnant during study duration, or patients of child-bearing potential who refuse effective birth control methods (as approved by PI)
  14. Active H. pylori infection or history of H pylori without treatment and confirmation of eradication
  15. Active gastric ulceration.
  16. Use of concomitant medications known to induce weight loss (including but not limited to liraglutide, phentermine, phentermine/topiramate, bupropion/naltrexone, metformin)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Gastric Fundal Mucosal Ablation (GFMA) following discontinuation of GLP-1 therapy
Subjects will undergo endoscopic Gastric Fundal Mucosal Ablation (GFMA) following following discontinuation of GLP-1 therapy. This will be performed by an experienced endoscopist specialized in bariatric endoscopy in a single endoscopic session.
Device: Gastric Fundal Mucosal Ablation (GFMA)
Endoscopic Gastric Fundal Mucosal Ablation (GFMA) after discontinuation of GLP-1 therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change in Total Body Weight Loss (TBWL) from Baseline
Time Frame: 12 months
Measure percent change in total body weight over time following endoscopic GFMA. TBWL = pre-op weight - post op body weight. % TBWL is the fraction of body weight expressed in percentage term
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of Adverse Events (AE)
Time Frame: Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12
Occurrence of Adverse Events along with AE Type, severity, and relationship to treatment.
Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12
Appetite and Hunger Assessment
Time Frame: Month 1, Month 2, Month 3, Month 6, Month 12
Baseline appetite and hunger assessment scores compared to follow-up appetite and hunger assessment scores. Appetite and hunger assessed and measured by the DAILY EATS questionnaire, which contains a numerical rating scale of 0-10 for each its 5 items. A higher score indicates greater hunger and appetite. A reduction in DAILY EATS score from baseline indicates a decrease in hunger and appetite levels, which is considered a positive outcome.
Month 1, Month 2, Month 3, Month 6, Month 12
Percent Change in Total Body Weight Loss (TBWL) from Baseline
Time Frame: Month 1, Month 3, Month 6, Month 9
Measure percent change in total body weight over time following endoscopic GFMA. TBWL = pre-op weight - post op body weight. % TBWL is the fraction of body weight expressed in percentage term
Month 1, Month 3, Month 6, Month 9
Change in Body Mass Index (BMI) from Baseline
Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12
Measure change in body mass index over time following endoscopic GFMA. BMI=(Weight in kg)/((Height in meters) ^2)
Month 1, Month 3, Month 6, Month 9, Month 12
Percent Weight Recurrence from Baseline
Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12

Measure percent recurrence in weight following endoscopic GFMA following discontinuation of semaglutide or tirzepatide.

% Weight recurrence = % of weight lost from semaglutide or tirzepatide that recurs after discontinuation
Month 1, Month 3, Month 6, Month 9, Month 12
Measured Proportion of Patients with weight recurrence
Time Frame: 6 Months, 12 Months
Measure percentage of patients with weight recurrence between <0%, 0-19.9%, 20-39.9%, 40-59.9%, 60-79.9%, 80-99.9%, vs 100% or more after GFMA.
6 Months, 12 Months
Eating Behavior and Weight Management Self-Efficacy Assessment
Time Frame: Month 1, Month 2, Month 3, Month 6, Month 12
Baseline eating behavior and weight management self-efficacy assessment scores compared to follow-up eating behavior and weight management self-efficacy scores measured by the WEL-SF questionnaire. WEL-SF is scored on a scale of 0-80 and includes 8 items measuring eating self-efficacy, which is the confidence one has in their ability to resist overeating. Higher WEL-SF scores indicate greater eating behavior self-efficacy and control. An increase in WEL-SF scores from baseline reflects an improvement in eating self-efficacy and is considered a positive outcome.
Month 1, Month 2, Month 3, Month 6, Month 12
Quality of Life Assessment
Time Frame: 1 Month, 2 Months, 3 Months, 6 Months, 12 Months
Baseline quality of life assessment scores compared to follow-up quality of life assessment scores. Quality of life score assessed and measured by the Impact of Weight on Quality of Life-Lite questionnaire. Scoring for the questionnaire ranges from 0 (minimum) to 100 (maximum). Higher scores for the Impact of Weight on Quality of Life-lite questionnaire indicates higher quality of life.
1 Month, 2 Months, 3 Months, 6 Months, 12 Months
Quality of Life Assessment
Time Frame: 1 Month, 2 Months, 3 Months, 6 Months, 12 Months
Baseline quality of life assessment scores compared to follow-up quality of life assessment scores. Quality of life score assessed and measured by the 36-Item Short Form Survey. Scoring for the questionnaire ranges from 0 (minimum) to 100 (maximum). Higher scores on the 36-Item Short Form Survey questionnaire indicates higher quality of life.
1 Month, 2 Months, 3 Months, 6 Months, 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. Christopher McGowan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher McGowan, MD, MSCR, True You Weight Loss

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PS-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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