Fractyl Health's Revita Meets Six-Month Co-Primary Endpoint in Ongoing REMAIN-1 Pivotal Study, With Highly Statistically Significant Reduction in Weight Regain After GLP-1 Discontinuation
Fractyl Health's REMAIN-1 pivotal study met its six-month co-primary endpoint, with a single Revita procedure retaining 80% of GLP-1-induced weight loss versus 67% for sham (p=0.0023) in the 308-participant mITT population. Post hoc analyses showed a dose-dependent effect: patients receiving a complete duodenal ablation of 20 cm or more regained 3.8% total body weight versus 8.2% for sham, a 53% reduction in weight regain. Interim safety data show no device- or procedure-related serious adverse events.
Key figures
- Drug Name
- Revita DMR System
- Phase Of Trial
- pivotal (REMAIN-1 Pivotal Cohort, N=308)
- Study participants
- 308
- Weight regain sham
- 8.2%
- Primary endpoint p value
- p=0.0023
- Weight loss retention sham
- 67%
- Weight stable or loss sham
- 18%
- Weight loss retention revita
- 80%
- Weight stable or loss revita
- 32%
- Regain reduction full ablation
- 53%
- Weight regain revita full ablation
- 3.8%
AI analysis
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