---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-082586"
form_type: "8-K"
ticker: "GUTS"
cik: "0001572616"
company_name: "FRACTYL HEALTH, INC."
filed_at: "2024-04-01T23:59:59+00:00"
generated_at: "2026-06-04T04:38:30.127274+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Fractyl Health Receives FDA IDE Approval for Revita Pivotal Study in Weight Maintenance

## Summary
- FDA approved Investigational Device Exemption for Revita Remain-1 pivotal study for weight maintenance after GLP-1RA discontinuation.
- Remain-1 is a randomized, double-blind trial vs sham in patients who lost ≥15% body weight on tirzepatide; at least 315 subjects randomized 2:1.
- Fractyl Health will also run Reveal-1 open-label cohort and provide updates in the second half of 2024.
- Revita is an outpatient endoscopic procedure targeting duodenum aimed at durable weight loss without ongoing medical therapy.
- CEO Harith Rajagopalan and Dr. Christopher Thompson highlighted the unmet need for durable weight maintenance solutions.

## SEC filing metadata
- accession: 0001193125-24-082586
- form_type: 8-K
- ticker: GUTS
- cik: 0001572616
- company_name: FRACTYL HEALTH, INC.
- filed_at: 2024-04-01T23:59:59+00:00
- event_type: regulatory
- 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/1572616/000119312524082586/0001193125-24-082586-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1572616/000119312524082586/d807199d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-082586
- JSON: https://secwatch.observer/filing/0001193125-24-082586.json
- Plain text: https://secwatch.observer/filing/0001193125-24-082586.txt

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