(RTTNews) - Fractyl Health, Inc. (GUTS) announced positive one-year randomized data from the REMAIN-1 Midpoint Cohort, demonstrating that its Revita duodenal mucosal resurfacing (DMR) system can help maintain weight loss after stopping GLP-1 therapy.
Fractyl Health is a clinical-stage metabolic therapeutics company focused on novel procedural approaches to obesity and type 2 diabetes management. Its Revita DMR system designed to provide a durable weight maintenance beyond pharmacologic therapy.
REMAIN-1 is a randomized, sham-controlled study evaluating Revita in patients who discontinued GLP-1 therapy. The Midpoint Cohort included 45 participants. The trial was designed to assess whether Revita could sustain weight loss and reduce weight regain after GLP-1 withdrawal, with FDA-mandated co-primary endpoints measuring weight-maintenance durability and responder rates.
•In the modified intention-to-treat population (N=45), a single Revita procedure reduced weight regain by approximately 40% versus sham at one year (7.8% vs 13.0% of body weight).
•Patients receiving complete duodenal ablation (>14 cm) maintained approximately 81% of GLP-1-induced weight loss at one year compared with 48% in sham participants, reflecting a >60% reduction in weight regain.
•In an optimized subgroup with higher GLP-1 run-in weight loss (=17.5%) approximately 84% of GLP-1-induced weight loss at one year versus 46% with sham.
•The FDA-mandated co-primary endpoint of responder rate (maintaining at least 5% total body weight loss at one year) was achieved by 73% of Revita patients in the Midpoint Cohort, rising to 91% in those with complete ablation.
These results reinforce Revita's potential as the first durable procedural therapy for post-GLP-1 weight maintenance, addressing a critical unmet need for patients who struggle with weight regain after discontinuing injectable therapies.
Fractyl anticipates topline six-month randomized data from the REMAIN-1 Pivotal Cohort in early Q4 2026, followed by a potential FDA De Novo marketing application submission in late Q4 2026.
GUTS has traded between $0.37 and $2.44 over the past year. The stock closed Tuesday's trading at $0.80, up 5.03%. In pre-market trading the stock is at $0.85, up 6.25%.
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