Fractyl Health, Inc. announced on October 16, 2026, that its REMAIN-1 Pivotal Cohort study met its six-month co-primary endpoint, demonstrating that its Revita DMR System helped patients maintain weight loss after discontinuing GLP-1 therapy. The study, a randomized, double-blind, sham-controlled trial, evaluated the safety and efficacy of the Revita system in adults with obesity who had previously used GLP-1 medications.
The primary finding showed that participants treated with a single Revita procedure maintained approximately 80% of their GLP-1-induced weight loss at the six-month mark. In comparison, participants who received a sham procedure maintained 67% of their weight loss. The difference was statistically significant, with a p-value of 0.0023. The study involved a modified intention-to-treat population of 308 participants, with 176 receiving Revita and 74 receiving the sham procedure.
Additional data from the study indicated that 32% of Revita participants were either weight stable or experienced further weight loss at the six-month mark, compared to 18% in the sham group. Post-hoc analysis revealed a dose-dependent effect, where participants receiving a complete duodenal ablation of 20 cm or more regained 3.8% of total body weight, compared to 8.2% in the sham group.
Regarding safety, the company reported that the Revita system has been well-tolerated. As of the September 24, 2026, data cut-off date, there were no device- or procedure-related serious adverse events, deaths, or unanticipated adverse device effects. Related adverse events were predominantly mild and occurred within seven days of the procedure.
Fractyl stated that it plans to submit a De Novo marketing application to the U.S. Food and Drug Administration in late Q4 2026. The company also noted that a dedicated Category III CPT code for the Revita procedure will take effect on January 1, 2027. Topline one-year data from the REMAIN-1 Pivotal Cohort is expected in the first quarter of 2027.
