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A first-in-human (FIH) study of RJVA-001 in Type 2 Diabetes (T2D)

Trial Profile

A first-in-human (FIH) study of RJVA-001 in Type 2 Diabetes (T2D)

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 06 Mar 2025

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At a glance

  • Drugs Glucagon like peptide 1 gene therapy Fractyl Health (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; First in man
  • Most Recent Events

    • 03 Mar 2025 According to a Fractyl Health media release, submission of the first CTA module for RJVA-001 in T2D to the regulatory authorities in 1H 2025, and if the CTA is authorized, the company expects to report preliminary data in 2026.
    • 31 Jan 2025 According to a Fractyl Health media release, Company is on track to initiate first-in-human studies for RJVA-001 in H1 2025.
    • 12 Nov 2024 According to a Fractyl Health media release, company is finalizing key in vivo studies to support the Clinical Trial Application (CTA) submission for RJVA-001 in T2D.

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