Fractyl's Revita Procedure Shows 6-Month Post-GLP-1 Weight Stability In REVEAL-1 Study

Fractyl Health

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(RTTNews) - Fractyl Health (GUTS) reported new six-month data from its open-label REVEAL-1 cohort, showing that people with obesity who stopped GLP-1 drugs maintained both weight and glycemic control after a single Revita procedure.

The company said the results highlight Revita's potential as a first-in-class option for patients who need an alternative to long-term GLP-1 therapy.

Participants had previously lost an average of 24% of body weight on GLP-1 medication. Six months after discontinuation, those treated with Revita showed only a 1.5% average weight change and nearly flat HbA1c levels, contrasting sharply with published data showing meaningful weight regain and glycemic deterioration after GLP-1 withdrawal alone.

The metabolic profile remained steady across one, three, and six months, with no serious procedure-related adverse events and only mild, transient side effects reported. Procedure performance was also consistent, mirroring global real-world use.

Clinicians involved in the study said the durability is striking given that most patients typically regain weight within weeks of stopping GLP-1 therapy. Fractyl added that the findings support Revita's FDA Breakthrough Device designation and strengthen confidence ahead of multiple 2026 clinical milestones, including randomized data from the ongoing REMAIN-1 program and a potential PMA filing later in the year.

REVEAL-1 includes 22 treated participants, with six-month efficacy data available for 17, most of whom are women around age 50 with prior long-term GLP-1 exposure.

GUTS currently trades at $1.485 or 4.8034% lower on the NasdaqGM.