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Trial · Interventional

RecruitingNot applicableRegistry data

MAINTAIN (Mucosal AblatIoN Therapy After INcretins)

Short name MAINTAIN

NCTNCT06734312 (opens ClinicalTrials.gov in a new tab)Other idPS-004
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Semaglutide, does not give it. It appears in an outcome measure.
  • Measures Tirzepatide, does not give it. It appears in an outcome measure.
  • Names Glucagon, does not test it. It appears in the title.

Overview

Status
Recruiting
Phase
Not applicable
Enrollment
20 participants (estimated)
Sponsor
Dr. Christopher McGowan · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
1 Jan 2025
Primary completion
Jun 2026 (estimated)
Completion
Jun 2026 (estimated)
First posted
16 Dec 2024
Last update posted
21 Mar 2025
Conditions
Obesity and Obesity-related Medical Conditions · Obesity and Overweight · Obesity Prevention · Obesity Recidivism · GLP-1 · Ablation Techniques

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027
  1. N/A

    MAINTAIN

    NCT06734312

    1 Jan 2025 to est. Jun 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Gastric Fundal Mucosal Ablation (GFMA)Device

Arms1

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Change in Total Body Weight Loss (TBWL) from Baseline

    Time frame · 12 months

    Registry description

    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

Secondary outcomes(9)

  1. 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

    Registry description

    Occurrence of Adverse Events along with AE Type, severity, and relationship to treatment.

  2. Quality of Life Assessment

    Time frame · 1 Month, 2 Months, 3 Months, 6 Months, 12 Months

    Registry description

    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.

  3. Quality of Life Assessment

    Time frame · 1 Month, 2 Months, 3 Months, 6 Months, 12 Months

    Registry description

    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.

  4. Appetite and Hunger Assessment

    Time frame · Month 1, Month 2, Month 3, Month 6, Month 12

    Registry description

    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.

  5. Percent Change in Total Body Weight Loss (TBWL) from Baseline

    Time frame · Month 1, Month 3, Month 6, Month 9

    Registry description

    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

  6. Change in Body Mass Index (BMI) from Baseline

    Time frame · Month 1, Month 3, Month 6, Month 9, Month 12

    Registry description

    Measure change in body mass index over time following endoscopic GFMA. BMI=(Weight in kg)/((Height in meters) \^2)

  7. Percent Weight Recurrence from Baseline

    Time frame · Month 1, Month 3, Month 6, Month 9, Month 12

    Registry description

    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

  8. Measured Proportion of Patients with weight recurrence

    Time frame · 6 Months, 12 Months

    Registry description

    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.

  9. Eating Behavior and Weight Management Self-Efficacy Assessment

    Time frame · Month 1, Month 2, Month 3, Month 6, Month 12

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

4 results

Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension.

Wilding et al. 2022Diabetes, obesity & metabolismcited by 874

PMID 35441470PMC9542252DOI 10.1111/dom.14725PUB-35441470

CC BY4 results
Download PDFSee results (4)

More studies

1 study on this page

Indexing hint: Review · 2023

Emerging Role of GLP-1 Agonists in Obesity: A Comprehensive Review of Randomised Controlled Trials.

Popoviciu et al. 2023International journal of molecular sciencescited by 223

PMID 37445623PMC10341852DOI 10.3390/ijms241310449PUB-37445623

CC BY
Download PDF

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

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