08:48 AM EDT, 06/23/2025 (MT Newswires) -- Fractyl Health ( GUTS ) said Monday that 12 of 13 participants in the open-label group of its ongoing pivotal study either maintained or lost weight three months after stopping GLP-1 therapy and undergoing a Revita procedure.

Median weight remained stable with a 0.46% total body weight change, contrasting with the typical 5% to 6% gain after GLP-1 withdrawal, the company said.

Six of the 13 participants experienced additional weight loss, and only one regained weight consistent with expectations after discontinuing GLP-1, Fractyl said.

The company also said the procedure continued to show a favorable safety profile, with no serious adverse events reported.

Fractyl said it expects to report data from two other cohorts in the same pivotal study. Midpoint cohort data are expected in Q3, followed by the pivotal cohort readout in H2 2026, the company said.

Shares of the company were down over 18% in recent premarket activity Monday.