MAINTAIN (Mucosal AblatIoN Therapy After INcretins)

Launched by DR. CHRISTOPHER MCGOWAN · Dec 12, 2024

Keywords

ClinConnect Summary

The MAINTAIN trial is studying a treatment called gastric fundal mucosal ablation (GFMA) to see how it affects weight loss in adults who have lost more than 10% of their weight using medications called semaglutide or tirzepatide. These medications are used for obesity, and the study looks at what happens when people stop taking them. Participants will be adults aged 21 to 65 with a body mass index (BMI) of 30 or higher, who are planning to stop using these medications.

To be eligible for the study, participants should have maintained their weight loss without gaining back more than half of the weight they lost since stopping the medication. They should not have any history of diabetes or serious stomach issues. If you join the trial, you can expect to undergo the GFMA procedure and participate in follow-up assessments to track your weight and health. It’s important to know that this study is currently recruiting participants, so those who meet the criteria and are interested can sign up to be part of it.

Gender

ALL

Eligibility criteria

• 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)