Background: Due to the progressive nature of T2D, patients often escalate in disease severity, burden, and complexity. Revita® Duodenal Mucosal Resurfacing (DMR) is a non-pharmacologic, investigational, endoscopic treatment intended to restore normal physiology of the duodenum, a key regulator of metabolic homeostasis. Previous studies to date with >300 patients have shown favorable safety and metabolic efficacy. Here we present initial data from open label phase of a pivotal study designed to improve glycemic control while reducing and/or eliminating insulin treatment burden.

Methods: Inclusion: 21-70yrs, BMI 24-40kg/m2, HbA1c 7.5-9.5%, FPG off insulin ≥180-<270mg/dL, fasting C-peptide ≥0.6 ng/ml, insulin (20-60 U/day) with background glucose lowering agents (GLAs). Prior to procedure, GLAs other than metformin and basal insulin were washed out for ≥8wks followed by 4wk run in. Post DMR, insulin was reinstated if needed by a pre-specified treat-to-target design with preexisting metformin and de novo empagliflozin.

Results: N=9. Median (min, max) baseline characteristics: age 60 (45, 68) yrs, 66.7% male, HbA1c 8.5 (7.6, 9.1)%, C-peptide 1.7 (0.7, 3.2) ng/mL, weight 96 (85, 128) kg, diabetes duration 13 (7, 24) yrs; long-acting insulin dose 33 (20, 60) U/day. No device or procedure related SAEs. Unrelated to DMR procedure, two patients discontinued early. N=7: 48-week median change from baseline (min, max); HbA1c -1.5% (-1.8,-0.4), FPG -82 mg/dL (-104,-48), total body weight -9.3% (-16.8,-2.9). All (7/7) patients reduced insulin dose with 2 patients discontinuing insulin entirely.

Conclusion: Results from open label phase thus far show promising safety and efficacy of Revita DMR and suggest broad metabolic benefit while reducing treatment burden. Further results forthcoming from currently enrolling REVITALIZE-1 study.


V.Fonseca: Consultant; Abbott, Corcept Therapeutics, Eli Lilly and Company, Other Relationship; BRAVO4HEALTH, LLC, Research Support; Fractyl Health, Inc., Stock/Shareholder; Amgen Inc. J.Bergman: Consultant; Endogenex, Fractyl Health, Inc., Digma Medical, Research Support; Endogenex, Fractyl Health, Inc., Digma Medical. Z.I.Saeed: None. H.Rajagopalan: Employee; Fractyl Health, Inc. B.Sorondo: Employee; Fractyl Health, Inc., LG Chem. K.White: Employee; Fractyl Health, Inc. H.Zhang: None. G.Mingrone: Advisory Panel; Fractyl Health, Inc., Board Member; Novo Nordisk, Consultant; Novo Nordisk, Fractyl Health, Inc., ReCor Medical, Inc.


Fractyl Health, Inc.

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