Early data shows Revita has potential to prevent weight regain after GLP-1 discontinuation

Fractyl Health has announced positive early data from the open-label REVEAL-1 cohort of its ongoing REMAIN-1 pivotal study. The results suggest that Revita, the company’s novel approach to targeting gut dysfunction, a root cause of obesity, may help prevent weight regain after patients stop GLP-1 drugs - addressing a growing unmet need in obesity treatment. As global GLP-1 adoption accelerates - and discontinuation rates climb - the need for scalable, non-pharmacologic solutions to sustain weight loss presents a significant, underleveraged commercial opportunity.

To-date, 15 patients have been treated in the REVEAL-1 cohort, with one-month data available for the first seven patients. These patients have been treated with a GLP-1 drug for up to three years before discontinuing medication, undergoing a single Revita procedure, and continuing a structured diet and lifestyle programme.

Key findings include:

• No safety or tolerability concerns reported in the 15 patients treated to date, consistent with Revita’s favourable safety profile from pooled data across more than 100 treated patients.

• At one-month post-procedure, seven patients experienced an average weight regain of just 1.2%, compared to the ~3% typically observed at this time period after GLP-1 discontinuation based on prior clinical studies.

“Stopping GLP-1 drugs often feels like a cliff for many patients - they fear regaining the weight they worked so hard to lose,” said Dr Mohammad Othman, William T Butler Endowed Chair and Professor of Medicine at Baylor College of Medicine. “These early data suggest that a well-tolerated, one-time procedure like Revita could offer patients a new, sustainable path forward without the need for ongoing medical treatment.”

Fractyl anticipates several key milestones for Revita in 2025:

• Additional REVEAL-1 patient follow-up data expected in Q2 2025

• Full REMAIN-1 pivotal study enrollment anticipated in summer 2025

• Midpoint analysis of REMAIN-1 pivotal study expected in Q3 2025

“The real challenge in obesity care isn’t just helping patients lose weight - it’s helping them keep it off,” said Dr Harith Rajagopalan, Co-Founder and CEO of Fractyl Health. “For the first time, we’re seeing early clinical data suggesting that Revita may offer a durable metabolic reset to help patients maintain their weight loss after GLP-1 therapy. I’m encouraged by these initial findings, and if they are confirmed in larger studies with longer follow-up, Revita has the potential to become a transformative option for patients at risk of weight regain.”

Revita is currently being studied under an open Investigational Device Exemption (IDE) in the US and holds FDA Breakthrough Device designation for weight maintenance in patients discontinuing GLP-1 therapy. The company aims to position Revita as the first approved intervention specifically for post-GLP-1 weight maintenance.