Fractyl Health submits first CTA module in Europe for RJVA-001 gene therapy in type 2 diabetes

FRACTYL HEALTH, INC.

Submitted first Clinical Trial Application module in Europe for RJVA-001, a gene therapy for type 2 diabetes.
Expects to dose first patients and report preliminary data in 2026, pending CTA authorization.
Phase 1/2 study: open-label, dose escalation; primary endpoints safety/tolerability, secondary HbA1c and fasting glucose.
Preclinical data (ASGCT 2025) showed safety, dose-dependent potency, adaptive nutrient-responsive secretion with low circulating GLP-1.
Company targets durable disease remission via one-time therapy, reducing burden of lifelong injectable GLP-1 drugs.

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