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MAINTAIN

RecruitingPhase NA

MAINTAIN (Mucosal AblatIoN Therapy After INcretins)

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

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

NCT IDNCT06734312
Org study IDPS-004

Timeline

Milestones

Study first posted2024-12-16actual
Study start2025-01-01actual
Last update posted2025-03-21actual
Primary completion2026-06estimated (month precision)
Study completion2026-06estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age21 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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
Patient-reported / QoL
4
Safety / tolerability / PK
1

Weight & body composition

5 endpoints
Primary/protocol endpoint

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

Time frame:12 months

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint/low confidence

Percent Weight Recurrence from Baseline

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

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Measured Proportion of Patients with weight recurrence

Time frame:6 Months, 12 Months

threshold achievement, improvement

Patient-reported / QoL

4 endpoints
Secondary/protocol endpoint

Quality of Life Assessment

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

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Quality of Life Assessment

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

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Appetite and Hunger Assessment

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

PGI, change

change from baseline, improvement

Secondary/protocol endpoint

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 endpoint
Secondary/protocol endpoint

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

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.