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.
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