Fractyl Health Inc ( GUTS ). on Tuesday revealed 6-month results from its open-label REVEAL-1 Cohort.

The REVEAL-1 Cohort is an open-label study in obese individuals who have lost at least 15% of their total body weight on a GLP-1 medication and who either need or choose to discontinue GLP-1 therapy.

The REVEAL-1 data show that patients who underwent a single Revita procedure after discontinuing GLP-1 therapy maintained both stable body weight and glycemic control through 6 months.

Also Read: Fractyl Health Stock Is Trading Lower Monday: What’s Going On?

Fractyl Health’s lead product candidate, Revita, is designed to remodel the duodenal lining via hydrothermal ablation (i.e., duodenal mucosal resurfacing) to reverse damage to intestinal nutrient-sensing and signaling mechanisms caused by chronic high-fat and high-sugar diets.

Key Findings

Participants lost 24% total body weight (>50 lbs.) on GLP-1 drugs before enrollment (duration on GLP-1 therapy ranging from 5 months to 5 years).

Participants maintained stable weight after a single Revita procedure, with a mean total body weight change of 1.5% ± 1.3% (SEM; n=17) at 6 months.

Minimal change in HbA1c levels was observed after the Revita procedure (0.04% ± 0.08%; SEM; n=17), compared to the ~0.4% increase in HbA1c seen post-GLP-1 discontinuation in the STEP-1 trial extension2 of GLP-1 withdrawal.

Mean body weight and HbA1c curves showed a stable and durable trajectory over time, consistent with prior Revita clinical study and real-world experience.

No procedure-related serious adverse events were observed; 8 of 22 participants (36%) experienced mild treatment-emergent adverse events, which were transient and self-limited; all consistent with prior Revita experience and similar to routine upper endoscopy findings.

Average ablation length was approximately 16 cm (n=22), consistent with Revita European real-world experience and the ongoing REMAIN-1 Pivotal study, supporting the potential translatability of results and scalability of technique.

GUTS Price Action: Fractyl Health ( GUTS ) shares were down 4.81% at $1.48 at the time of publication on Tuesday, according to Benzinga Pro data.

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