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Fractyl Health Completes Randomization in REMAIN-1 Pivotal Cohort of Revita® for Post-GLP-1 Weight Maintenance
Topline 6-month pivotal data expected in early Q4 2026 with potential FDA marketing application submission expected in late Q4 2026 Company reiterates cash
About this update from Fractyl Health, Inc.
[{"type":"text","content":"Topline 6-month pivotal data expected in early Q4 2026 with potential FDA marketing application submission expected in late Q4 2026 Company reiterates cash runway guidance into early 2027, beyond anticipated pivotal data readout BURLINGTON, Mass., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes, today announced completion of participant randomization in its REMAIN-1 Pivotal Cohort, a double-blind, sham-controlled study evaluating Revita® for weight maintenance following GLP-1 therapy discontinuation. “Completion of randomization in the REMAIN-1 Pivotal Cohort marks an important milestone as we advance Revita toward the definitive clinical evidence we believe will clearly establish its role in post-GLP-1 weight maintenance,” said Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health. “This study was prospectively designed and statistically powered to demonstrate Revita’s effect. The clinical insights from our REVEAL-1 and REMAIN-1 Midpoint Cohorts, as well as ongoing follow-up from our Germany Real-World Registry study, informed both the study design and our confidence in this program. With randomization now complete and our balance sheet positioned to support us through and beyond the pivotal readout, our focus is on disciplined execution as we prepare to report topline 6-month results in early Q4 2026. We are grateful to the participants, investigators, and clinical site teams whose commitment has made this progress possible.” Pivotal Study Designed to Deliver Definitive Evidence The REMAIN-1 Pivotal Cohort is a randomized, double-blind, sham-controlled study evaluating Revita in adults with obesity (BMI ≥30 kg/m2 and ≤45 kg/m2) who achieved ≥15% total body weight loss on tirzepatide. Following GLP-1 discontinuation, participants were randomized 2:1 to receive Revita or a sham endoscopic procedure. The co-primary endpoints are percent total body weight regain (Revita vs sham) at 6 months, and proportion of participants maintaining ≥5% total body weight loss at 12 months (responder rate). All participants receive standardized diet and lifestyle counseling throughout the study. “The level of patient interest we experienced at...