True You Weight Loss, the nation’s first dedicated endobariatric weight loss center, has announced two new FDA-authorized clinical trials focused on providing innovative, non-surgical weight loss solutions without relying on GLP-1 medications. These studies expand True You’s portfolio of ten active clinical trials, reinforcing its leadership in advancing non-surgical treatments for long-term weight loss.
Earlier this year, True You Weight Loss introduced a groundbreaking weight loss procedure called gastric fundal mucosal ablation (GFMA). This innovative, non-surgical technique was first unveiled at Digestive Disease Week in May, and the first human results were published in the December 2024 issue of Gastroenterology. The procedure has since gained national attention, setting the stage for the launch of two pivotal clinical trials: MAINTAIN and REVAMP.
GFMA is performed by a gastroenterologist using an endoscope to ablate the inner lining of the gastric fundus, the upper part of the stomach. This procedure reduces the production of ghrelin, a hormone that stimulates hunger, which leads to a significant reduction in appetite and rapid weight loss. GFMA is currently available exclusively at True You Weight Loss, where nearly 300 procedures have been successfully completed with exceptional safety and promising results.
The MAINTAIN Trial
The MAINTAIN trial, or Mucosal Ablation Therapy After Incretins, is the first study designed to assess the impact of GFMA on weight maintenance after discontinuing GLP-1 medications such as Wegovy (semaglutide) or Mounjaro (tirzepatide). These medications are highly effective in promoting weight loss, but many patients experience rapid weight regain once the treatment ends. The MAINTAIN trial aims to determine whether GFMA can help prevent this weight regain by targeting the body’s hunger pathways, specifically reducing ghrelin levels, which could offer a sustainable alternative to lifelong GLP-1 therapy.
Dr. Christopher McGowan, the founder of True You Weight Loss and lead investigator of the trial, emphasizes the importance of this study. “While GLP-1 medications are effective, they do not create lasting changes in the body. Once stopped, hunger and weight often return. GFMA targets the body’s strongest hunger hormone, providing patients with long-term appetite control and sustainable weight management,” he explained. Many patients undergoing GFMA report fewer cravings and a healthier relationship with food, without the side effects and high costs of ongoing weight loss medications.
The REVAMP Trial
The REVAMP trial, or Revision of Vertical Sleeve Gastrectomy with Ablation of the Mucosa Procedure, is the first study to explore whether GFMA can assist patients who have regained weight after undergoing vertical sleeve gastrectomy (VSG), a type of bariatric surgery. This trial will treat patients who have regained at least 25% of their weight loss following VSG. The goal is to see if mucosal ablation can help these patients lose weight again without additional surgeries or medication.
“Obesity is a chronic condition, and many patients who have bariatric surgery experience weight recurrence over time,” said Dr. McGowan. “REVAMP will evaluate whether mucosal ablation can offer these patients a non-surgical option to regain weight loss.” This trial is particularly important for patients who have undergone bariatric surgery but have seen their weight return, highlighting the potential for non-surgical solutions in weight management.
About True You Weight Loss, PLLC
True You Weight Loss, founded by Dr. Christopher McGowan, is the nation’s first dedicated endobariatric weight loss center. It offers a wide range of endobariatric procedures, including endoscopic sleeve gastroplasty (ESG), bariatric revisional procedures, intragastric balloon placement, and medical nutrition therapy. True You has also reached the milestone of performing over 5,000 endobariatric procedures, solidifying its position as a leader in the field of non-surgical weight loss.
