Fractyl Health Single Revita Procedure Retains 78% of GLP-1 Weight Loss at One Year
GUTS•Fractyl Health’s REVEAL-1 open-label results show patients retained 78% of prior GLP-1–induced weight loss one year after a single Revita procedure, with a mean 5.3% reduction and 33% of participants still losing weight. No serious adverse events were reported, and one-year randomized data arrive in Q3 2026.
1. Positive One-Year Efficacy Results
Participants in the REVEAL-1 open-label cohort retained approximately 78% of prior GLP-1–induced weight loss one year after a single Revita procedure, experiencing a mean total body weight change of 5.3% ± 2.1% (n=15) and 5.8% ± 2.0% (n=22). Notably, 33% of subjects continued to lose weight one year after discontinuing GLP-1 therapy, following initial losses of ~24% total body weight on GLP-1 drugs.
2. Safety and Tolerability Findings
No procedure-related serious adverse events occurred, and no new treatment-emergent adverse events were observed beyond those typical of routine upper endoscopy. Mild transient adverse events affected 36% of participants (8 of 22) within the first month, with no late device-related issues reported.
3. Comparative Weight Regain Data
Third-party studies have documented roughly 15% weight regain one year after GLP-1 withdrawal alone, underscoring Revita’s potential to stabilize and sustain drug-induced weight loss through a minimally invasive ablation procedure.
4. Upcoming Trial Milestones
Fractyl Health expects to report one-year randomized data from the REMAIN-1 Midpoint Cohort in Q3 2026 and topline six-month outcomes from the REMAIN-1 Pivotal Cohort in early Q4 2026, providing controlled comparisons for Revita’s durability as a post-GLP-1 weight maintenance therapy.
