Fractyl Health completes REMAIN-1 randomization, eyes early Q4 2026 topline data
Fractyl Health completed randomization in its REMAIN-1 pivotal cohort evaluating Revita in post-GLP-1 weight maintenance for obesity patients with BMI 30–45 kg/m2 and ≥15% prior weight loss on tirzepatide. Topline 6-month data are expected early Q4 2026, with potential FDA submission late Q4 2026 and cash runway into early 2027.
1. REMAIN-1 Pivotal Cohort Randomization Completed
Fractyl Health has finalized participant randomization in its REMAIN-1 Pivotal Cohort, a double-blind, sham-controlled study of Revita in adults with obesity (BMI 30–45 kg/m2) who achieved ≥15% total body weight loss on tirzepatide. Participants were randomized 2:1 to receive the Revita endoscopic procedure or a sham control, with standardized diet and lifestyle counseling throughout.
2. Key Clinical and Regulatory Timeline
The company anticipates FDA feedback on a De Novo pathway for Revita in Q2 2026, 1-year data from the REVEAL-1 Cohort in Q2 2026, 1-year randomized data from the REMAIN-1 Midpoint Cohort in Q3 2026, topline 6-month results from the pivotal cohort in early Q4 2026 and a potential marketing application submission in late Q4 2026.
3. Cash Runway Supports Through Pivotal Readout
Fractyl Health reiterates that its current cash position will fund operations through early 2027, covering costs for upcoming 2026 clinical milestones and the pivotal REMAIN-1 data readout without additional financing.