Fractyl Health has reported positive one-year data from the midpoint cohort of its Phase 2 REMAIN-1 trial, showing that its Revita duodenal mucosal resurfacing system helped patients maintain significantly more weight loss after stopping GLP-1 therapy than a sham procedure.

The randomised, sham-controlled study evaluated Revita as a potential treatment to reduce weight regain following discontinuation of GLP-1 medicines. The company said the results support the device’s potential as a non-drug option for long-term weight maintenance after GLP-1 treatment.

Across the modified intention-to-treat population of 45 participants, patients treated with Revita regained an average of 7.8% of their body weight over one year compared with 13.0% in the sham group. According to the company, this equated to approximately 40% less weight regain following a single procedure.

The strongest results were seen among patients who received more extensive duodenal ablation, where participants maintained around 81% of their GLP-1-induced weight loss after one year compared with 48% in the sham arm.

In a smaller subgroup of patients who experienced greater weight loss during GLP-1 treatment before entering the trial, Revita maintained approximately 84% of the original weight loss, compared with 46% in patients who underwent the sham procedure.

The study also assessed one of the co-primary endpoints planned for the pivotal REMAIN-1 cohort: maintaining at least 5% total body weight loss relative to pre-tirzepatide weight after one year. In the midpoint cohort, 73% of patients receiving Revita met this threshold, increasing to 91% among those who underwent complete duodenal ablation.

Safety findings remained favourable through 12 months. Fractyl reported no device- or procedure-related serious adverse events and no new device-related treatment-emergent adverse events between six and 12 months. Overall adverse event rates were similar between the Revita and sham groups.

Harith Rajagopalan, co-founder and chief executive officer of Fractyl Health, said: **“The success of GLP-1 medicines has created a new unsolved problem: what happens when patients stop. Most do stop eventually, whether because of cost, side effects, or simply not wanting to inject a drug for the rest of their lives. When they stop, the weight most often comes back.

“Today’s results are the first randomized, sham-controlled evidence that a single Revita procedure can keep most of the weight off for a full year after GLP-1 is stopped, without the need for ongoing medication. We eagerly anticipate an early Q4 2026 topline readout from the REMAIN-1 Pivotal Cohort with deep conviction that Revita may represent the first procedural entrant into the post-GLP-1 weight maintenance category.”

Fractyl is now preparing for topline six-month data from the pivotal REMAIN-1 cohort, expected in early Q4 2026. Subject to positive results, the company also plans to submit a De Novo marketing application to the FDA later in the year.