CARY, N.C.--(BUSINESS WIRE)--True You Weight Loss, the nation’s first dedicated endobariatric weight loss center, today announced two new FDA-authorized clinical trials aimed at providing innovative, non-surgical solutions for long-term weight loss without the need for GLP-1 medications. These studies are part of True You’s growing portfolio of ten active clinical trials, solidifying its position as a global leader in advancing non-surgical weight loss treatments.
Earlier this year, True You Weight Loss introduced a ground-breaking weight loss procedure called gastric fundal mucosal ablation (GFMA). This innovative technique debuted at Digestive Disease Week in May with the first-in-human results published in the December 2024 issue of Gastroenterology, gaining national attention and momentum.
GMFA is a non-surgical technique in which a gastroenterologist uses an endoscope to ablate (thermally treat) the inner lining of the gastric fundus, the top portion of the stomach. This procedure reduces levels of the hunger hormone ghrelin, resulting in decreased appetite and rapid weight loss. Offered exclusively at True You Weight Loss, the team has now performed nearly 300 GFMA cases with exceptional safety and promising outcomes, leading to two new trials: MAINTAIN and REVAMP.
The MAINTAIN Trial
The MAINTAIN trial (Mucosal AblatIoN Therapy After INcretins) is the first-ever study to evaluate the impact of GFMA on weight maintenance after discontinuing GLP-1 medications such as Wegovy/Ozempic (semaglutide) or Mounjaro/Zepbound (tirzepatide). The study aims to determine whether GFMA can prevent or minimize weight regain in adults transitioning off these medications, offering a potential solution for patients who cannot or prefer not to continue lifelong GLP-1 therapy due to cost, side effects, supply issues, or medication fatigue.
“This is an important study coming at a critical time, said Dr. Christopher McGowan, founder of True You Weight Loss and lead investigator of the study. While GLP-1 medications are highly effective during use, they do not induce permanent changes in the body. Once the medication is discontinued, hunger and weight often return quickly. With GFMA, we aim to target the body’s strongest hunger pathway—the ghrelin hormone—offering patients long-term appetite control and sustainable weight management. Our GFMA patients report an altered relationship with food—including reduced cravings and food noise—without the side effects and ongoing cost of weight loss medications.”
The REVAMP Trial
The REVAMP trial (REvision of VSG with Ablation of the Mucosa Procedure) is the first study to evaluate whether the mucosal ablation procedure can promote weight loss in patients who have regained weight after vertical sleeve gastrectomy (VSG). This single-session, non-surgical ablation procedure will treat patients who have regained at least 25 percent of their initial weight loss following VSG.
“Obesity is a chronic, lifelong condition, and patients deserve lasting treatments,” said Dr. McGowan. “Many patients who undergo bariatric surgery experience weight recurrence over time. REVAMP will explore whether mucosal ablation can help these patients lose weight again without the need for additional surgeries or medications.”
Both MAINTAIN and REVAMP will run for one year and are actively enrolling participants. “These trials represent a major step forward in developing non-surgical, effective weight loss solutions,” Dr. McGowan added. “At True You Weight Loss, we are committed to transforming the landscape of weight management by offering innovative procedures that prioritize patient outcomes and safety.” For more information on these innovative studies and other active research projects, please visit https://trueyouweightloss.com/research/.
About True You Weight Loss, PLLC
Founded by Dr. Christopher McGowan, True You Weight Loss, PLLC, is the nation’s first dedicated endobariatric weight loss center. True You Weight Loss offers a comprehensive range of endobariatric procedures and support services to help patients lose weight, including endoscopic sleeve gastroplasty (ESG), bariatric revisional procedures, intragastric balloon placement, and medical nutrition therapy. It is the only center in the nation to reach the milestone of 5,000 endobariatric weight loss procedures. To learn more, visit www.trueyouweightloss.com or follow True You on Facebook and Instagram.
