After pivoting at the top of this year from treating diabetes to focusing on an obesity landscape dominated by GLP-1s, Fractyl Health has shown that its one-time procedure can help maintain or continue weight loss after people stop taking the medication.
The company’s Revita system and its ability to reset the metabolism of the small intestine had been studied for years in people with Type 2 diabetes, showing improvements in insulin resistance and blood sugar levels.
However, in January, Fractyl announced layoffs and a pause on investments in those clinical studies—with a switch to pitching its approach as a potential “off-ramp” for those looking to stop taking GLP-1s.
Now, in what it describes as a readout from the “midpoint cohort” of its REMAIN-1 randomized study, Fractyl said that Revita-treated patients lost an additional 2.5% of their body weight in the three months after their last dose of Eli Lilly’s Zepbound (tirzepatide). Participants in the control group, meanwhile, regained 10% of their total weight.
The cohort included 45 people with obesity who had achieved at least 15% weight loss with Zepbound. The company said this group is designed to mirror a separate, planned “pivotal cohort,” and provide an initial validation of the study’s endpoints and design.
“These results are a defining milestone for Fractyl and the obesity community,” CEO Harith Rajagopalan said in a statement. “This is a compelling demonstration that targeting the gut may provide a remarkable and clinically significant improvement in obesity.”
“Patients want durable weight loss without the need for chronic medical therapy,” Rajagopalan added. “The Revita clinical profile in this study suggests we have the potential to create a new standard of care in obesity with a disease-modifying intervention that allows us to progress from chasing weight loss to sustaining health with a durable metabolic reset.”
The study also showed no serious complications from the Revita resurfacing procedure, with its heated, water-filled balloon that strips down the inner mucosal walls of the duodenum, which can thicken from years of dietary fats, sugars and other foods.
REMAIN-1’s midpoint cohort will continue gathering data, with six-month results expected in the first quarter of next year. Meanwhile, Fractyl said it has completed enrollment of the pivotal cohort and will randomize patients in early 2026, toward the goal of applying for FDA approval in the latter half of the year.
This month also saw Fractyl open a $60 million stock offering, with 60 million shares priced at $1 apiece, following its 2024 IPO.