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Procedure

Gastric Fundal Mucosal Ablation for Obesity (MAINTAIN Trial)

Cary, NC

N/A

Recruiting

Led By Christopher McGowan, MD, MSCR

Research Sponsored by Dr. Christopher McGowan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have recently discontinued or are planning to discontinue semaglutide or tirzepatide (≤ 24 weeks from last dose to time of study procedure)

No previous medical history of diabetes mellitus

Must not have

Known diagnosis of type I or type II diabetes or a Hemoglobin A1c > 6.5% at time of screening

Use of GLP-1 or GLP-1/GIP medication for the treatment of diabetes, rather than obesity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 1, month 2, month 3, month 4, month 6, month 7, month 8, month 9, month 10, month 11, month 12

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see how removing a part of the stomach lining affects weight changes after stopping certain weight loss medications in obese adults who have lost more than 10% of their weight with a specific type

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Who is the study for?

The MAINTAIN trial is for adults with obesity who have lost more than 10% of their weight using GLP-1 therapy like semaglutide or tirzepatide and are planning to stop taking these medications. The study aims to see if a procedure called GFMA can help maintain their weight loss after stopping the medication.Check my eligibility

What is being tested?

This clinical trial tests Gastric Fundal Mucosal Ablation (GFMA), a procedure designed to help individuals maintain their weight loss achieved through GLP-1 therapy, even after they've stopped taking the GLP-1 drugs.See study design

What are the potential side effects?

Potential side effects of GFMA may include discomfort at the treatment site, digestive issues such as nausea or bloating, bleeding, infection risk from the procedure, and possible nutritional deficiencies due to changes in stomach function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have stopped or will stop taking semaglutide or tirzepatide within 6 months before the study.

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I have never been diagnosed with diabetes.

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I am between 21 and 65 years old.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes or my Hemoglobin A1c level is above 6.5%.

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I use GLP-1 medication for diabetes, not for weight loss.

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I am not willing to stop taking incretin mimetics during the study.

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I am not taking medications that are known to cause weight loss.

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I currently have or had an untreated H. pylori infection without confirmation it's gone.

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I have a bleeding disorder that cannot be medically corrected.

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I am able and willing to give my consent to participate in the study.

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I have been diagnosed with gastroparesis or functional dyspepsia.

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I currently have an active stomach ulcer.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 1, month 2, month 3, month 4, month 6, month 7, month 8, month 9, month 10, month 11, month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 1, month 2, month 3, month 4, month 6, month 7, month 8, month 9, month 10, month 11, month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 1, month 2, month 3, month 4, month 6, month 7, month 8, month 9, month 10, month 11, month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Appetite and Hunger Assessment

Change in Body Mass Index (BMI) from Baseline

Eating Behavior and Weight Management Self-Efficacy Assessment

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Gastric Fundal Mucosal Ablation (GFMA) following discontinuation of GLP-1 therapyExperimental Treatment1 Intervention

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.

0 / 12Eligibility criteria met