GUTS

Study Overview: Fractyl Health Inc. announced 6-month results from the REVEAL-1 Cohort, an open-label study involving obese individuals who lost significant weight on GLP-1 medications and chose to discontinue therapy.

Key Findings: Participants who underwent a single Revita procedure maintained stable body weight and glycemic control, with minimal changes in HbA1c levels, demonstrating the procedure's effectiveness after GLP-1 withdrawal.

Safety and Efficacy: No serious adverse events were reported, and mild treatment-emergent adverse events were transient, aligning with previous Revita experiences and routine endoscopy findings.

Market Reaction: Following the announcement, Fractyl Health's stock price fell by 4.81%, trading at $1.48.

Study Findings: Fractyl Health's REVEAL-1 cohort data shows that individuals with obesity who underwent a single Revita procedure maintained weight and glycemic control after stopping GLP-1 drugs, contrasting with typical weight regain seen after discontinuation of such therapies.

Procedure Efficacy: Participants who had previously lost an average of 24% body weight on GLP-1 medication experienced only a 1.5% average weight change and stable HbA1c levels six months post-Revita treatment, with no serious adverse events reported.

Clinical Significance: The results suggest Revita could serve as a first-in-class alternative for patients needing to discontinue long-term GLP-1 therapy, supporting its FDA Breakthrough Device designation and upcoming clinical milestones.

Participant Demographics: The study involved 22 participants, primarily women around age 50, with six-month efficacy data available for 17 of them, most having prior long-term exposure to GLP-1 medications.

Study Findings: Fractyl Health's Revita outpatient endoscopic procedure helped patients who had previously lost weight on GLP-1 medications maintain their weight, with a mean total body weight change of 1.5% after six months.

HbA1c Levels: The procedure resulted in minimal change in HbA1c levels (0.04% ± 0.08%), contrasting with a ~0.4% increase typically seen after discontinuing GLP-1 drugs.

Safety Profile: No serious adverse events were reported during the study, although 8 out of 22 participants experienced mild treatment-emergent adverse events.

Context of GLP-1 Medications: Despite the popularity of GLP-1 drugs like Wegovy and Zepbound for weight loss, many users discontinue due to side effects, highlighting the potential value of alternative treatments like Revita.