Procedure Helps Prevent Weight Regain After Discontinuation of GLP-1 Medication
The outpatient endoscopic procedure modifies duodenal dysfunction and restores metabolic health.
Revita, Fractyl Health’s outpatient endoscopic procedure, can help to prevent weight regain after patients discontinue glucagon-like peptide-1 (GLP-1) medication. The procedure modifies duodenal dysfunction and restores metabolic health, according to the company.1
The outpatient endoscopic procedure modifies duodenal dysfunction and restores metabolic health. | Image Credit: Douglas - stock.adobe.com
"Stopping GLP-1 drugs often feels like a cliff for many patients—they fear regaining the weight they worked so hard to lose," Mohammad Othman, MD, William T. Butler Endowed chair and professor of medicine at Baylor College of Medicine, said in a news release.1 "These early data suggest that a well-tolerated, 1-time procedure like Revita could offer patients a new, sustainable path forward without the need for ongoing medical treatment."
In the REVEAL-1 trial, 15 patients were treated. Each patient previously received a GLP-1 medication for up to 3 years before discontinuing and undergoing the Revita procedure. The patients continued a structured diet and lifestyle program, according to Fractyl Health. The early data showed no safety or tolerability concerns for the 15 patients treated so far, which remained consistent with the safety profile from more than 100 patients pooled from other data. At 1 month postprocedure, 7 patients had an average weight regain of 1.2% compared to approximately 3% that is typically seen during this time frame for patients who discontinued GLP-1 medication.1
In January 2025, the company announced initial results from the REVEAL-1 study, showing that the first patient in the study achieved a 15% total body weight loss with tirzepatide (Zepbound, Mounjaro) over a 7-month period. After discontinuing and undergoing Revita, the weight loss was maintained for 1 month after the procedure.2
The study is a randomized, double-blind trial of Revita compared with a sham for patients who lost at least 15% of their total body weight using tirzepatide. Patients in the REMAIN-1 study have a body mass index of 30 kg/m2 or greater and were GLP-1 naïve before starting tirzepatide. There will be at least 315 patients included and receiving randomized treatment 2:1 to Revita or the sham. The primary end points included the percent change in body weight from baseline to week 21 and the proportion of patients maintaining weight loss after discontinuing therapy. Fractyl Health also launched REVEAL-1, which is an open-label cohort that followed a similar patient population and protocol.3
"The real challenge in obesity care isn’t just helping patients lose weight—it’s helping them keep it off," Harith Rajagopalan, MD, PhD, co-founder and CEO of Fractyl Health, said in the news release.1 "For the first time, we’re seeing early clinical data suggesting that Revita may offer a durable metabolic reset to help patients maintain their weight loss after GLP-1 therapy."
The company expects to announce follow-up data for the REVEAL-1 patients in quarter 2 of 2025 and achieve full enrollment for REMAIN-1 in summer 2025. For REMAIN-1, the company expects a midpoint analysis in quarter 3 of 2025.1
