---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-048033"
form_type: "8-K"
ticker: "GUTS"
cik: "0001572616"
company_name: "FRACTYL HEALTH, INC."
filed_at: "2025-04-01T23:59:59+00:00"
generated_at: "2026-05-24T00:47:38.180725+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Fractyl Health reports early REVEAL-1 data suggests Revita prevents weight regain after GLP-1 stop

## Summary
- First 7 patients showed average weight regain of 1.2% at 1 month vs typical ~3% after GLP-1 discontinuation.
- No safety or tolerability concerns in 15 patients treated to date; consistent with prior pooled data.
- REMAIN-1 pivotal study now >50% enrolled; full enrollment expected summer 2025; midpoint analysis Q3 2025.
- Revita holds FDA Breakthrough Device designation for post-GLP-1 weight maintenance.
- Additional REVEAL-1 follow-up data expected in Q2 2025.

## SEC filing metadata
- accession: 0000950170-25-048033
- form_type: 8-K
- ticker: GUTS
- cik: 0001572616
- company_name: FRACTYL HEALTH, INC.
- filed_at: 2025-04-01T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1572616/000095017025048033/0000950170-25-048033-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1572616/000095017025048033/guts-20250401.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-048033
- JSON: https://secwatch.observer/filing/0000950170-25-048033.json
- Plain text: https://secwatch.observer/filing/0000950170-25-048033.txt

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