Fractyl Health's Revita Procedure Shows Durable Weight Maintenance in REVEAL-1 Cohort

Fractyl Health released 3-month results from the REVEAL-1 Cohort of its REMAIN-1 pivotal trial, showing that its Revita procedure may sustain weight loss after stopping GLP-1 therapy. Of 13 participants, 12 maintained or lost additional weight three months after a single Revita treatment, with a median weight change of just 0.46%. Revita was well tolerated with no serious adverse events. Fractyl plans to present randomized Midpoint Cohort data in Q3 and six-month pivotal results in H2 2026.

Fractyl Health, Inc. (Nasdaq: GUTS) has released positive 3-month data from the REVEAL-1 Cohort of its REMAIN-1 pivotal study, indicating that its Revita procedure may sustain weight loss after stopping GLP-1 therapy. The company announced that 12 out of 13 participants either maintained or lost additional weight three months after a single Revita treatment, with a median weight change of just 0.46% [1].

The REVEAL-1 Cohort is an open-label cohort within the REMAIN-1 pivotal study, designed to evaluate the safety, tolerability, and early efficacy signals of Revita in individuals with obesity who have lost at least 15% of their total body weight on a recently discontinued GLP-1 therapy. The cohort consists of 22 participants, with 3-month follow-up data available for 13 individuals. The median age of participants is 49, and the gender distribution is 11 women and 2 men [1].

The results show that Revita continued to demonstrate excellent tolerability, with no serious adverse events observed. Only one participant experienced weight regain similar to that seen after tirzepatide withdrawal. The median weight remained stable through 3 months, compared to the typical 5-6% (10–15 pounds) rebound seen in clinical studies such as SURMOUNT-41 [1].

Fractyl plans to present randomized Midpoint Cohort data in Q3 2025 and six-month pivotal results in H2 2026. These upcoming data readouts are designed to demonstrate Revita’s potential to help maintain weight loss after GLP-1 discontinuation and inform its possible role in supporting durable metabolic outcomes [1].

References:
[1] https://www.globenewswire.com/news-release/2025/06/23/3103292/0/en/Fractyl-Health-Reports-Positive-3-Month-REVEAL-1-Cohort-Data-Showing-Revita-Sustained-Weight-Loss-After-GLP-1-Discontinuation-Supporting-its-Potential-as-a-First-in-Class-Weight-Ma.html