Fractyl Health reports early data from REVEAL-1 cohort of REMAIN-1 study

Fractyl Health (GUTS) announced positive early data from the open-label REVEAL-1 cohort of its ongoing REMAIN-1 pivotal study. The results suggest that Revita, the Company’s novel approach to targeting gut dysfunction, a root cause of obesity, may help prevent weight regain after patients stop GLP-1 drugs-addressing a growing unmet need in obesity treatment. As global GLP-1 adoption accelerates-and discontinuation rates climb-the need for scalable, non-pharmacologic solutions to sustain weight loss presents a significant, underleveraged commercial opportunity. Key findings include: No safety or tolerability concerns reported in the 15 patients treated to date, consistent with Revita’s favorable safety profile from pooled data across more than 100 treated patients. At 1-month post-procedure, 7 patients experienced an average weight regain of just 1.2%, compared to the ~3% typically observed at this time period after GLP-1 discontinuation based on prior clinical studies. Fractyl anticipates several key milestones for Revita in 2025: Additional REVEAL-1 patient follow-up data expected in Q2 2025; Full REMAIN-1 pivotal study enrollment anticipated in summer 2025; Midpoint analysis of REMAIN-1 pivotal study expected in Q3 2025