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

FRACTYL HEALTH, INC.

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.

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