---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-218508"
form_type: "8-K"
ticker: "GUTS"
cik: "0001572616"
company_name: "FRACTYL HEALTH, INC."
filed_at: "2025-09-26T23:59:59+00:00"
generated_at: "2026-05-17T05:33:55.519363+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Fractyl's Revita maintains weight loss after GLP-1 stop; 2.5% further loss vs 10% regain in sham (p=0.014)

## Summary
- Revita-treated patients (n=29) lost additional 2.5% total body weight at 3 months after stopping tirzepatide; sham (n=16) regained 10% (p=0.014).
- No Revita-related SAEs or Grade II+ AEs observed; side effects mild/transient, consistent with prior studies.
- REMAIN-1 Midpoint Cohort ongoing; 6-month data expected Q1 2026.
- Pivotal cohort randomization on track for early 2026; 6-month topline data and potential PMA filing in H2 2026.
- Results provide first randomized, blinded evidence of durable drug-free weight maintenance post-GLP-1.

## SEC filing metadata
- accession: 0001193125-25-218508
- form_type: 8-K
- ticker: GUTS
- cik: 0001572616
- company_name: FRACTYL HEALTH, INC.
- filed_at: 2025-09-26T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1572616/000119312525218508/0001193125-25-218508-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1572616/000119312525218508/d870124d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-218508
- JSON: https://secwatch.observer/filing/0001193125-25-218508.json
- Plain text: https://secwatch.observer/filing/0001193125-25-218508.txt

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