Fractyl Health's Revita System Shows Promise in Maintaining GLP-1 Weight Loss

Fractyl Health has announced promising midpoint results from its REMAIN-1 study, demonstrating the potential of its Revita system to maintain weight loss in patients who discontinue GLP-1 medications. This development marks a significant milestone in the company's pivot towards addressing the growing obesity market.

Revita System Outperforms Control Group in Weight Maintenance

The REMAIN-1 study's midpoint cohort, consisting of 45 participants who had achieved at least 15% weight loss with Eli Lilly's Zepbound (tirzepatide), showed remarkable results. Patients treated with the Revita system continued to lose an additional 2.5% of their body weight in the three months following their last dose of Zepbound. In contrast, the control group regained 10% of their total weight during the same period.

Fractyl Health CEO Harith Rajagopalan hailed these results as "a defining milestone for Fractyl and the obesity community," emphasizing the potential of targeting the gut to provide "a remarkable and clinically significant improvement in obesity."

Revita's Mechanism and Safety Profile

The Revita system employs a novel approach to metabolic reset, using a heated, water-filled balloon to resurface the inner mucosal walls of the duodenum. This procedure aims to address the thickening of these walls caused by years of dietary fats, sugars, and other foods.

Importantly, the study reported no serious complications from the Revita resurfacing procedure, underlining its potential as a safe alternative or complement to chronic medical therapy for obesity.

Future Outlook and Clinical Development

Fractyl Health is moving forward with its clinical development plans. The company has completed enrollment for the pivotal cohort of the REMAIN-1 study, with patient randomization expected in early 2026. This timeline positions Fractyl to potentially apply for FDA approval in the latter half of 2026.

Additionally, six-month results from the midpoint cohort are anticipated in the first quarter of 2026, which will provide further insights into the long-term efficacy of the Revita system.

As part of its growth strategy, Fractyl recently opened a $60 million stock offering, pricing 60 million shares at $1 each. This move follows the company's IPO in 2024 and reflects ongoing investor interest in novel obesity treatments.