BURLINGTON, Mass., May 19, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS), a company specializing in metabolic therapeutics, has announced the submission of the first module of its Clinical Trial Application $(CTA.UK)$ in Europe for RJVA-001. This gene therapy candidate from Fractyl's Rejuva platform aims to address type 2 diabetes and obesity by expressing glucagon-like peptide-1 (GLP-1) locally in pancreatic beta cells. The therapy is designed to enable physiologic hormone secretion without the high circulating levels associated with current systemic GLP-1 drug therapies, potentially reducing side effects. Pending regulatory clearance, Fractyl plans to begin first-in-human dosing and report preliminary data in 2026. The study will assess the safety, tolerability, and early efficacy of this one-time, pancreas-targeted gene therapy in patients with inadequately controlled type 2 diabetes and obesity.
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