True You Weight Loss, the first dedicated endobariatric weight loss center, has announced the launch of two new FDA-authorized clinical trials focusing on innovative, non-surgical weight loss solutions. These trials, named MAINTAIN and REVAMP, will explore the use of gastric fundal mucosal ablation (GFMA) to address weight management challenges, either after discontinuing GLP-1 medications or following weight regain after bariatric surgery.
Gastric Fundal Mucosal Ablation (GFMA)
GFMA is a non-surgical technique where a gastroenterologist uses an endoscope to ablate the inner lining of the gastric fundus, the top portion of the stomach. This process aims to reduce the levels of ghrelin, a hormone that stimulates hunger, leading to decreased appetite and subsequent weight loss. True You Weight Loss has performed nearly 300 GFMA procedures, reporting promising safety and efficacy outcomes.
MAINTAIN Trial: Weight Maintenance After GLP-1s
The MAINTAIN (Mucosal Ablation Therapy After INcretins) trial is designed to evaluate the impact of GFMA on weight maintenance after patients stop using GLP-1 medications such as semaglutide (Wegovy/Ozempic) or tirzepatide (Mounjaro/Zepbound). The study seeks to determine if GFMA can prevent or minimize weight regain in adults transitioning off these medications. This is particularly relevant given that many patients face challenges with the cost, side effects, supply issues, or general fatigue associated with long-term GLP-1 therapy.
"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."
REVAMP Trial: Addressing Weight Regain After VSG
The REVAMP (REvision of VSG with Ablation of the Mucosa Procedure) trial will assess whether mucosal ablation can promote weight loss in patients who have regained weight after undergoing vertical sleeve gastrectomy (VSG). This single-session, non-surgical ablation procedure will be offered to 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."
Trial Details and Enrollment
Both the MAINTAIN and REVAMP trials are set to run for one year and are currently enrolling participants. These trials signify a significant advancement in the development of non-surgical, effective weight loss solutions. True You Weight Loss emphasizes its commitment to transforming weight management by offering innovative procedures that prioritize patient outcomes and safety.
