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MAINTAIN
RecruitingPhase NAMAINTAIN (Mucosal AblatIoN Therapy After INcretins)
Gastric Fundal Mucosal Ablation for Weight Management in Patients Stopping Glucagon-like Peptide-1 Receptor Agonists
Lead sponsor
Assets
Semaglutide / Tirzepatide
Listed sites
2
Recruiting sites
1
Enrollment
20
estimated
Study population
Obesity / overweight
Key I/E criterion
•BMI ≥30
Primary endpoint
•Body weight, % change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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)
Endpoints (10)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
5 endpointsPercent Change in Total Body Weight Loss (TBWL) from Baseline
Time frame:12 months
Body weight, % change
percent change from baseline, improvement
Percent Change in Total Body Weight Loss (TBWL) from Baseline
Time frame:Month 1, Month 3, Month 6, Month 9
Body weight, % change
percent change from baseline, improvement
Change in Body Mass Index (BMI) from Baseline
Time frame:Month 1, Month 3, Month 6, Month 9, Month 12
BMI, change
change from baseline, improvement
Percent Weight Recurrence from Baseline
Time frame:Month 1, Month 3, Month 6, Month 9, Month 12
percent change from baseline, improvement
Measured Proportion of Patients with weight recurrence
Time frame:6 Months, 12 Months
threshold achievement, improvement
Patient-reported / QoL
4 endpointsQuality of Life Assessment
Time frame:1 Month, 2 Months, 3 Months, 6 Months, 12 Months
IWQOL-Lite total
change from baseline, improvement
Quality of Life Assessment
Time frame:1 Month, 2 Months, 3 Months, 6 Months, 12 Months
SF-36 total
change from baseline, improvement
Appetite and Hunger Assessment
Time frame:Month 1, Month 2, Month 3, Month 6, Month 12
PGI, change
change from baseline, improvement
Eating Behavior and Weight Management Self-Efficacy Assessment
Time frame:Month 1, Month 2, Month 3, Month 6, Month 12
change from baseline, improvement
Safety / tolerability / PK
1 endpointRate 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
Treatment-emergent AEs (any)
event count, event
Publications (3)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- International journal of molecular sciences2023 Jun 21PMID37445623doi:10.3390/ijms241310449via CT.gov background
- Diabetes, obesity & metabolism2022 Aug (month)PMID35441470doi:10.1111/dom.14725via CT.gov background
- Gastrointestinal endoscopy2018 Jul (month)PMID29476845doi:10.1016/j.gie.2018.02.022via CT.gov background
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.