CARY, N.C. – True You Weight Loss, the nation’s first center specializing in endobariatric weight loss treatments, has announced two new FDA-approved clinical trials. These trials aim to provide innovative, non-surgical weight loss solutions without the need for GLP-1 medications. The studies are part of True You’s expanding portfolio of active clinical trials, strengthening its position as a leader in advancing non-surgical weight loss treatments.
Earlier this year, True You introduced a pioneering procedure called gastric fundal mucosal ablation (GFMA), which gained national attention after its debut at Digestive Disease Week in May. The first human results were published in the December 2024 issue of Gastroenterology.
GFMA is a non-surgical procedure where a gastroenterologist uses an endoscope to treat the inner lining of the gastric fundus, the upper part of the stomach. This treatment reduces the levels of ghrelin, the hunger hormone, leading to reduced appetite and significant weight loss. True You Weight Loss has already performed nearly 300 GFMA procedures, achieving strong safety outcomes and promising results. These successes have paved the way for two new clinical trials: MAINTAIN and REVAMP.
The MAINTAIN Trial
The MAINTAIN Trial (Mucosal Ablation Therapy After Incretins) is the first study to assess the effectiveness of GFMA in maintaining weight loss after discontinuing GLP-1 medications such as Wegovy, Ozempic, and Mounjaro. This study aims to determine if GFMA can help prevent or reduce weight regain in adults transitioning off these medications. This is a critical issue for patients who can no longer continue GLP-1 therapy due to factors like cost, side effects, or medication fatigue.
Dr. Christopher McGowan, founder of True You Weight Loss and lead investigator of the study, highlighted the importance of this research: “While GLP-1 medications are effective, they don’t cause permanent changes in the body. Once patients stop the medication, hunger and weight often return quickly. With GFMA, we target ghrelin, the body’s strongest hunger hormone, offering long-term appetite control and sustainable weight management.”
Dr. McGowan also noted that many patients who undergo GFMA report a shift in their relationship with food, including reduced cravings and less mental “food noise,” without the ongoing costs and side effects of weight loss medications.
The REVAMP Trial
The REVAMP Trial (Revision of VSG with Ablation of the Mucosa Procedure) is the first study to investigate whether GFMA can help patients who have regained weight after undergoing vertical sleeve gastrectomy (VSG). This procedure is aimed at those who have regained at least 25% of the weight they initially lost after VSG.
“Obesity is a chronic condition, and patients deserve long-term solutions,” said Dr. McGowan. Many bariatric surgery patients experience weight gain over time. The REVAMP trial will explore whether mucosal ablation can help these patients lose weight again without needing additional surgeries or medications.”
Trial Details and Enrollment
Both the MAINTAIN and REVAMP trials will last for one year and are currently enrolling participants. “These trials represent a significant 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 with innovative procedures that prioritize patient outcomes and safety.”
For more information on these trials and other ongoing research, visit True You Weight Loss Research.
