MAINTAIN (Mucosal AblatIoN Therapy After INcretins)

NCT06734312 | Recruiting DMC FDA Device

• 1 other identifier: PS-004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Obesity and Obesity-related Medical Conditions; Obesity and Overweight; Obesity Prevention; Obesity Recidivism; GLP-1; Ablation Techniques

Keywords

obesity; obesity and overweight; endoscopic bariatric therapy; ablation; gastric mucosal ablation; GMA; GFMA; glp-1; weight loss medications; weight loss; semaglutide; tirzepatide; hunger; appetite

Outcome Measures

Primary Outcomes (1)

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

  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

  12 months

Secondary Outcomes (9)

• Rate of Adverse Events (AE)

  Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12

• Quality of Life Assessment

  1 Month, 2 Months, 3 Months, 6 Months, 12 Months

• Quality of Life Assessment

  1 Month, 2 Months, 3 Months, 6 Months, 12 Months

• Appetite and Hunger Assessment

  Month 1, Month 2, Month 3, Month 6, Month 12

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

  Month 1, Month 3, Month 6, Month 9

Study Arms (1)

Gastric Fundal Mucosal Ablation (GFMA) following discontinuation of GLP-1 therapy

EXPERIMENTAL

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.

Device: Gastric Fundal Mucosal Ablation (GFMA)

Interventions

Gastric Fundal Mucosal Ablation (GFMA) DEVICE

Endoscopic Gastric Fundal Mucosal Ablation (GFMA) after discontinuation of GLP-1 therapy

Gastric Fundal Mucosal Ablation (GFMA) following discontinuation of GLP-1 therapy

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 21-65
• Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≤45 kg/m²
• Observed ≥ 10% TBWL with semaglutide or tirzepatide use for primary obesity therapy
• Subject did not experience \>50% weight recurrence since discontinuation of semaglutide or tirzepatide
• Maintained a stable dose of semaglutide or tirzepatide for a minimum of 12 weeks
• 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
• Willing and able to participate in the study procedures
• Understand and voluntarily sign the informed consent

You may not qualify if:

• 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.
• Use of anticoagulation, antithrombotic agents, and/or NSAIDs that cannot be discontinued for a minimum of 12 weeks
• Known bleeding diathesis that cannot be corrected through medical means.
• History of decompensated end-organ disease
• Unwillingness to abstain from the use of incretin mimetics during the study duration.
• Unwillingness to abstain from the use of tobacco during the study duration
• Patients on any medications or supplements including those that may influence cholecystokinin (CCK), glucose, growth hormone, insulin and/or somatostatin levels
• History of any stomach manipulation (including repair of hiatal hernia or fundoplication) deemed unsafe by PI for GFMA
• Active disordered eating
• 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
• Known diagnosis of gastroparesis or functional dyspepsia
• 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)
• Active H. pylori infection or history of H pylori without treatment and confirmation of eradication
• Active gastric ulceration.

Sponsors & Collaborators

• Dr. Christopher McGowan: lead

Study Sites (2)

True You Weight Loss

Cary, North Carolina, 27513, United States

NOT YET RECRUITING

True You Weight Loss

Cary, North Carolina, 27513, United States

RECRUITING

Related Publications (3)

• Kumbhari V, Lehmann S, Schlichting N, Heinrich M, Kullnick Y, Retschlag U, Enderle M, Dietrich A, Khashab MA, Kalloo AN, Oberbach A. Gastric mucosal devitalization is safe and effective in reducing body weight and visceral adiposity in a porcine model. Gastrointest Endosc. 2018 Jul;88(1):175-184.e1. doi: 10.1016/j.gie.2018.02.022. Epub 2018 Feb 22.

  PMID: 29476845 BACKGROUND

• Wilding JPH, Batterham RL, Davies M, Van Gaal LF, Kandler K, Konakli K, Lingvay I, McGowan BM, Oral TK, Rosenstock J, Wadden TA, Wharton S, Yokote K, Kushner RF; STEP 1 Study Group. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes Obes Metab. 2022 Aug;24(8):1553-1564. doi: 10.1111/dom.14725. Epub 2022 May 19.

  PMID: 35441470 BACKGROUND

• Popoviciu MS, Paduraru L, Yahya G, Metwally K, Cavalu S. Emerging Role of GLP-1 Agonists in Obesity: A Comprehensive Review of Randomised Controlled Trials. Int J Mol Sci. 2023 Jun 21;24(13):10449. doi: 10.3390/ijms241310449.

  PMID: 37445623 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Christopher McGowan, MD, MSCR

  True You Weight Loss

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon Casey, MS

CONTACT

(919) 391-7843; Shannon@trueyouweightloss.com

Chase Wooley, BS

CONTACT

(984) 345-2988; Chase@trueyouweightloss.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Founder/Co-CEO/Chief Medical Officer

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 16, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 21, 2025

Record last verified: 2025-01

Locations

US (2)