Fractyl Health, Inc. (GUTS), Tuesday announced positive early data from the open-label REVEAL-1 cohort of its ongoing REMAIN-1 pivotal study, suggesting that Revita may help prevent weight regain after patients stop GLP-1 drugs.
In the cohort, 15 patients were treated. Of this, 1-month data for the first 7 patients was available, showing an average weight regain of just 1.2 percent compared to about 3 percent typically observed during this period in the previous clinical studies.
Additionally, no safety or tolerability concerns were reported in the fifteen patients.
The metabolic therapeutics company now anticipates additional REVEAL-1 patient follow-up data in the second quarter of 2025, full REMAIN-1 pivotal study enrollment in summer of 2025, and midpoint analysis of REMAIN-1 pivotal study in the third quarter of 2025.
Notably, Revita is currently being studied under an open Investigational Device Exemption in the U.S. and holds FDA Breakthrough Device designation for weight maintenance in patients discontinuing GLP-1 therapy.
In the pre-market hours, Fractyl's stock is trading at $1.28, up 7.56 percent on the Nasdaq.
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