---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-073988"
form_type: "8-K"
ticker: "GUTS"
cik: "0001572616"
company_name: "FRACTYL HEALTH, INC."
filed_at: "2025-05-19T23:59:59+00:00"
generated_at: "2026-05-21T01:34:27.049313+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0000950170-25-073988
- form_type: 8-K
- ticker: GUTS
- cik: 0001572616
- company_name: FRACTYL HEALTH, INC.
- filed_at: 2025-05-19T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1572616/000095017025073988/0000950170-25-073988-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1572616/000095017025073988/guts-20250519.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-073988
- JSON: https://secwatch.observer/filing/0000950170-25-073988.json
- Plain text: https://secwatch.observer/filing/0000950170-25-073988.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.