Fractyl says its single catheter treatment maintained most GLP-1 weight loss

Fractyl Health (NASDAQ: GUTS) reported randomized clinical trial results demonstrating that patients maintained up to 84% of GLP-1-induced weight loss with its Revita technology one year after discontinuing GLP-1 medication, the company announced today.

“The success of GLP-1 medicines has created a new unsolved problem: what happens when patients stop. Most do stop eventually, whether because of cost, side effects, or simply not wanting to inject a drug for the rest of their lives. When they stop, the weight most often comes back,” Fractyl co-founder and CEO Dr. Harith Rajagopalan said in a news release. 

Fractyl’s REMAIN-1 Midpoint Cohort study is a randomized, double-blind, sham-controlled proof-of-concept study evaluating its Revita DMR System for weight management in adults with obesity one year after discontinuing GLP-1 therapy following at least 15% total body weight loss using tirzepatide. 

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The Revita system consists of a console containing proprietary software and technology, a single-use lineset and a single-use catheter for hydrothermal ablation. Revita targets the duodenal mucosa (first 25 cm of the small intestine beyond the stomach) in a minimally invasive endoscopic ablation procedure. It ablates damaged tissue to enable the regeneration of healthier duodenal mucosa that could restore normal metabolic regulation.

Revita received FDA breakthrough device designation in 2021.

“This [technology] addresses the most significant unmet need in obesity today, durable weight maintenance after stopping GLP-1 therapy,” Rajagopalan said on an investor call. “The data shows something many people believe was not possible: that durable drug-free weight maintenance can be achieved with a single outpatient endoscopic procedure.”

In a full modified intention-to-treat population, participants who received complete duodenal ablation maintained approximately 81% of GLP-1-induced weight loss at one year compared to 48% in sham participants, the company reported. 

The results were positive in patients who lost more weight during GLP-1 therapy. In an optimized patient population with patients who had higher GLP-1 run-in weight loss (≥17.5%), Revita patients maintained 84% of GLP-1-induced weight loss at one year compared with 46% in the sham population.  

“These results are consistent with the view that patients at greatest need may derive the greatest benefit from Revita due to their higher propensity for weight regain after GLP-1 discontinuation,” the company said in a press release. 

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Throughout the study, no device- or procedure-related serious adverse events occurred, the company reported. Overall device-related treatment-emergent adverse events were limited to abdominal discomfort, sore throat, nausea and dry mouth, Rajagopalan said, and were comparable between the Revita and sham populations. These events resolved within two days, he said.

“Revita is like LASIK for obesity and it targets the underlying cause of disease with a single outpatient procedure rather than relying on chronic medication,” Rajagopalan said. “This approach is particularly valuable in the post GLP-1 setting where millions of patients are looking to maintain their weight loss without staying on therapy long term.”

Fractyl’s next benchmarks for Revita are topline six-month randomized data from its REMAIN-1 pivotal trial expected in early quarter four 2026 and a potential FDA de novo marketing application submission in late quarter four 2026. 

“We see room for even further profile optimization in the future as we continue to develop our technology,” Rajagopalan said.