Fractyl Health reports 1‑year REMAIN‑1 data showing sustained weight loss after GLP‑1 therapy

Fractyl Health (GUTS) announced positive one‑year results from the Midpoint Cohort of its REMAIN‑1 study. The Revita DMR System reduced weight regain by about 40% compared with a sham procedure, and among patients with complete duodenal ablation of more than 14 cm, participants maintained roughly 81% of their GLP‑1‑induced weight loss versus 48% in the sham group. Weight regain was 4.8% of body weight in the Revita group versus 13% in the sham group, exceeding the FDA‑mandated performance goal of over 50% for maintaining at least a 5% total body‑weight loss—73% of Revita patients met this benchmark. The responder rate rose to 91% in the fully ablated subgroup. No device‑ or procedure‑related serious adverse events were reported, and overall adverse‑event rates were similar between groups. The company plans to release topline six‑month data from the larger REMAIN‑1 Pivotal Cohort in early Q4 2026 and is targeting a potential FDA De Novo marketing application later that quarter. Shares rose more than 8% in pre‑market trading following the announcement.