Fractyl Health’s REVEAL-1 Study Shows Positive Six-Month Results for Revita in Maintaining Weight and Glycemic Control Post-GLP-1 Use

Fractyl Health Inc. (NASDAQ:GUTS) is one of the best biotech penny stocks to buy according to analysts. On December 2, Fractyl Health announced positive six-month results from its open-label REVEAL-1 study. The data showed that a single Revita procedure, a hydrothermal ablation designed to remodel the duodenal lining, successfully maintained stable body weight and glycemic control in patients who had recently discontinued GLP-1 medications.

Participants in the study had previously lost an average of 24% of their total body weight (over 50 lbs.) while on GLP-1 therapy for durations ranging from 5 months to 5 years. The findings are significant when compared to typical outcomes following the withdrawal of GLP-1 drugs. While published third-party studies show a weight regain of ~10% within 6 months of stopping medication, Revita-treated participants showed a mean weight change of only 1.5%.

Fractyl Health’s REVEAL-1 Study Shows Positive Six-Month Results for Revita in Maintaining Weight and Glycemic Control Post-GLP-1 Use

Furthermore, metabolic stability was mirrored in blood sugar levels; while historical data from the STEP-1 trial indicated a 0.4% increase in HbA1c post-discontinuation, REVEAL-1 participants experienced a minimal change of only 0.04%.

Fractyl Health Inc. (NASDAQ:GUTS) now expects to release midpoint randomized data from its REMAIN-1 study in January 2026, followed by one-year data for REVEAL-1 in Q2. By H2 2026, the company anticipates topline results from the REMAIN-1 Pivotal Cohort and a potential Premarket Approval/PMA filing with the FDA. Revita currently holds an FDA Breakthrough Device designation for weight maintenance in patients discontinuing GLP-1-based drugs.

Fractyl Health Inc. (NASDAQ:GUTS) is a metabolic therapeutics company that develops therapies for the treatment of type 2 diabetes/T2D and obesity.

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Disclosure: None. This article is originally published at Insider Monkey.