---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-028228"
form_type: "8-K"
ticker: "GUTS"
cik: "0001572616"
company_name: "FRACTYL HEALTH, INC."
filed_at: "2026-01-29T23:59:59+00:00"
generated_at: "2026-05-16T06:28:12.896117+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Fractyl Health reports positive 6-month Revita data; 70% weight regain reduction in key subgroup

## Summary
- Revita-treated patients (n=40) had 4.5% weight regain vs 7.5% sham at 6 months (p=0.07) in REMAIN-1 Midpoint Cohort.
- In above-median GLP-1 weight loss subgroup, Revita achieved 70% relative reduction in weight regain vs sham (p=0.004).
- Revita improved cardiometabolic markers: HDL +15.5 vs +3.9 mg/dL (p=0.01) and reduced sweet-food cravings (p=0.04).
- No serious adverse events related to Revita; no study discontinuations due to adverse events through 6 months.
- Fractyl requested FDA feedback on De Novo reclassification for Revita; feedback expected Q2 2026.

## SEC filing metadata
- accession: 0001193125-26-028228
- form_type: 8-K
- ticker: GUTS
- cik: 0001572616
- company_name: FRACTYL HEALTH, INC.
- filed_at: 2026-01-29T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1572616/000119312526028228/0001193125-26-028228-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1572616/000119312526028228/guts-20260129.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-028228
- JSON: https://secwatch.observer/filing/0001193125-26-028228.json
- Plain text: https://secwatch.observer/filing/0001193125-26-028228.txt

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