---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-423377"
form_type: "8-K"
ticker: "GUTS"
cik: "0001572616"
company_name: "FRACTYL HEALTH, INC."
filed_at: "2026-10-16T11:01:22+00:00"
generated_at: "2026-10-16T11:05:09.643087+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 hits REMAIN-1 six-month endpoint, cutting post-GLP-1 weight regain 80% vs 67% sham (p=0.0023)

## Summary
- Six-month co-primary endpoint met in mITT (N=308): Revita maintained ~80% of GLP-1-induced weight loss vs 67% for sham; mean weight regain 5.1% vs 8.2% (p=0.0023).
- 32% of Revita participants were weight-stable or lost more weight at 6 months post-GLP-1 discontinuation vs 18% for sham (post hoc; nominal p=0.020).
- Dose response: 12-18 cm duodenal ablation cut regain 43% vs sham (4.7% vs 8.2%; n=107); 20 cm or more cut regain 53% (3.8%; n=47).
- Safety: no device- or procedure-related serious adverse events or deaths; no unanticipated device effects at the Sept. 24, 2026 cut-off; 94% of related AEs were within 7 days.
- Plans FDA De Novo submission in late Q4 2026, 12-month data plus second co-primary endpoint in Q1 2027, CPT code 1122T effective Jan 1, 2027, potential U.S. launch early 2028.

## SEC filing metadata
- accession: 0001193125-26-423377
- form_type: 8-K
- ticker: GUTS
- cik: 0001572616
- company_name: FRACTYL HEALTH, INC.
- filed_at: 2026-10-16T11:01:22+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/1572616/000119312526423377/0001193125-26-423377-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1572616/000119312526423377/guts-20261016.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-423377
- JSON: https://secwatch.observer/filing/0001193125-26-423377.json
- Plain text: https://secwatch.observer/filing/0001193125-26-423377.txt

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