---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-076424"
form_type: "8-K"
ticker: "GUTS"
cik: "0001572616"
company_name: "FRACTYL HEALTH, INC."
filed_at: "2024-06-24T23:59:59+00:00"
generated_at: "2026-06-01T02:27:23.807576+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Fractyl Health accelerates REMAIN-1 study, expands REVITALIZE-1 eligibility

## Summary
- REMAIN-1 weight maintenance study accelerated; open-label REVEAL-1 data expected Q4 2024.
- Midpoint data analysis for REMAIN-1 now anticipated in Q2 2025.
- FDA approved protocol amendment for REVITALIZE-1: expands eligibility to any glucose lowering agent; potential U.S. treatment population ~6x to ~25M patients.
- Topline data from REVITALIZE-1 expected mid-2025.
- Preclinical data for Rejuva gene therapy vs semaglutide showed greater, more durable weight loss in mice; presented at ADA 84th Scientific Sessions.

## SEC filing metadata
- accession: 0000950170-24-076424
- form_type: 8-K
- ticker: GUTS
- cik: 0001572616
- company_name: FRACTYL HEALTH, INC.
- filed_at: 2024-06-24T23:59:59+00:00
- event_type: other_material
- 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/1572616/000095017024076424/0000950170-24-076424-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1572616/000095017024076424/guts-20240624.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-076424
- JSON: https://secwatch.observer/filing/0000950170-24-076424.json
- Plain text: https://secwatch.observer/filing/0000950170-24-076424.txt

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