Fractyl Health, Inc. (GUTS), a clinical-stage metabolic therapeutics company, on Thursday announced positive one-year results for Revita from its REVEAL-1 Cohort study.
Revita is the company's lead product candidate, designed to remodel the duodenal lining of the small intestine through a one-time, minimally invasive endoscopic procedure aimed at restoring healthy nutrient sensing and signaling disrupted by chronic metabolic disease.
The open-label REVEAL-1 Cohort enrolled individuals with obesity who had lost at least 15% of their total body weight on GLP-1 medications and either needed or chose to discontinue therapy.
Results from the study showed that participants who underwent a single Revita procedure maintained approximately 78% of their prior GLP-1-induced weight loss one year after discontinuing GLP-1 therapy, while 33% of patients continued to lose weight during the period. Participants maintained stable weight, with a mean total body weight change of 5.3% ± 2.1% at one year.
Further, all patients in the REVEAL-1 Cohort maintained at least 5% of their GLP-1-induced weight loss through one year.
The study also showed minimal changes in HbA1c levels following the Revita procedure, with a mean increase of 0.08%.
Fractyl said no procedure-related serious adverse events or new treatment-emergent adverse events were observed during the study.
The company expects to report one-year data for Revita from the REMAIN-1 Midpoint Cohort in the third quarter of 2026, followed by topline six-month data from the REMAIN-1 Pivotal Cohort in early fourth-quarter 2026.
Fractyl shares were up more than 4% in pre-market trading after closing at $0.76 on Wednesday.
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