Fractyl Health Announces 6-Month Randomized Results From Ongoing REMAIN-1 Midpoint Cohort, Blinded, Sham-Controlled Study Evaluating Revita For Weight Maintenance Following GLP-1 Drug Discontinuation
Benzinga Newsdesk 9 months ago
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Revita-treated patients experienced sustained weight maintenance, improved cardiometabolic profile, and reduced food cravings at 6 months compared with sham, with continued excellent safety and tolerabilityPatients with
Revita-treated patients experienced sustained weight maintenance, improved cardiometabolic profile, and reduced food cravings at 6 months compared with sham, with continued excellent safety and tolerability
Patients with above median GLP-1-associated weight loss experienced ~ 70% less post-GLP-1 weight regain with Revita vs sham at 6 months
Results support pivotal study design and further substantiate Revita's potential to be the first durable procedural therapy for post-GLP-1 weight maintenance; topline 6-month pivotal data and potential FDA filing expected in H2 2026
Based on ongoing interactions and favorable safety data to date, the Company has requested FDA feedback on reclassifying Revita under the De Novo pathway, which is expected in Q2 2026
Company to host investor call and webcast today at 8:00 a.m. ET
BURLINGTON, Mass., Jan. 29, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) (the Company or Fractyl), a metabolic therapeutics company developing disease-modifying solutions for obesity and type 2 diabetes, today announced positive six-month randomized results from the ongoing REMAIN-1 Midpoint Cohort, a blinded, sham-controlled study evaluating Revita® for weight maintenance following GLP-1 drug discontinuation. These results reinforce the biological rationale for Revita, support the potential durability of effect, and provide increased confidence in the ongoing REMAIN-1 pivotal study.