Fractyl Health has released data from its REMAIN-1 Midpoint Cohort showing that patients treated with its investigational procedure, Revita®, continued to lose weight three months after stopping GLP-1 therapy, according to the company.
In the randomized, double-blind, sham-controlled study (N = 45), participants first achieved at least 15 % total body weight loss while on tirzepatide. After discontinuation, they were randomized in a 2:1 ratio to receive either Revita or a sham endoscopic procedure. The primary endpoint was change in total body weight at three months.
The company claims that Revita-treated patients lost an additional 2.5 % of body weight over that period, while sham-treated participants regained 10 %, with a reported p-value of 0.014. The company also reports no serious adverse events or grade II+ adverse events related to Revita, and says side effects have been rare, mild and transient.
Fractyl says that these interim results reinforce confidence in the design of its pivotal trial, which has completed enrollment. Six-month randomized data from the Midpoint Cohort are expected in the first quarter of 2026. The company anticipates filing a pre-market approval (PMA) application in the second half of 2026 if results are favorable.
Revita employs a duodenal mucosal resurfacing technique, aiming to remodel the gut lining and reset nutrient-sensing signals. Fractyl holds U.S. FDA Breakthrough Device designation for Revita in weight maintenance following GLP-1 discontinuation.
