Fractyl reports 7.8% weight regain with Revita

• Fractyl Health reported 7.8% weight regain with Revita versus 13% with sham after one year.
• Fractyl shares rose 5% to $0.84 following the clinical data announcement.
• The company expects Pivotal Cohort data in early Q4 2026 and could submit an FDA De Novo application in late Q4.

Fractyl Health (NASDAQ:GUTS) reported one-year REMAIN-1 data showing 7.8% weight regain with Revita versus 13% with sham in 45 participants.

The randomized, double-blind study evaluated adults who lost at least 15% of their body weight with tirzepatide before discontinuing treatment.

Participants receiving more than 14 centimetres of duodenal ablation maintained about 81% of prior weight loss, while adverse-event rates were 24% with Revita and 25% with sham.

Following the announcement, Fractyl Health's share price was up 5% at $0.84.

Fractyl’s earlier REVEAL-1 open-label study found participants maintained about 78% of GLP-1-induced weight loss one year after receiving Revita.

Fractyl expects six-month Pivotal Cohort data in early Q4 2026 and said a potential FDA De Novo application could follow in late Q4 2026.