After spending years developing its endoscopic device treatment for patients with Type 2 diabetes, Fractyl Health is now fully pivoting its research toward obesity and people on GLP-1s.
The company said it will pause investments in ongoing clinical studies of its Revita system in Type 2 diabetes—and instead lean on the pitch that its outpatient, intestinal-relining procedure can provide an “off-ramp” for people looking to stop taking GLP-1 medications and still maintain their weight loss.
Fractyl will shed 17% of its staff, or 22 employees, through layoffs that aim to extend its cash runway into 2026—while it also looks to advance its Rejuva gene therapy platform for obesity into first-in-human studies.
"The real challenge in obesity is no longer losing weight, it is keeping the weight off,” Fractyl co-founder and CEO Harith Rajagopalan said in a statement.
The company said another driver of the decision was the high interest it received in its REMAIN-1 clinical study, which is testing the Revita system in people who have lost at least 15% of their body weight with GLP-1s.
Earlier this month, Fractyl said that the first patient enrolled in the double-blinded study, who underwent the Revita procedure after taking tirzepatide for seven months, showed no weight gain during the following four weeks—a time when many patients experience rapid metabolic rebounds.
“The strong response from patients and physicians to the REMAIN-1 study highlights the urgent need for durable weight maintenance solutions, and we are doubling down on our efforts in this space,” Rajagopalan said, with Fractyl estimating that enrollment in the trial will support a midpoint analysis by the end of June. The pivotal study signed up more than 100 participants across eight sites in less than four months, according to the company.
“Revita is the first therapeutic candidate to receive Breakthrough Device designation for weight maintenance, and we are uniquely positioned to address this critical gap,” he added.
Revita works through hydrothermal ablation—by filling a balloon with hot water, it strips away the thickened interior lining of the small intestine. This mucosal layer of the duodenum, potentially thickened by years of dietary fats and sugars, can interfere with the organ’s production of hormones that help govern metabolism and insulin resistance.
The former Fierce 15 winner’s approach was previously aimed at allowing people with Type 2 diabetes to go months without needing insulin and had demonstrated gains in HbA1c as well as liver fat levels. Its current development work included the REVITALIZE-1 study and a real-world patient registry in Germany.
Meanwhile, Fractyl’s gene therapy—an adeno-associated virus vector-powered treatment targeting the pancreas, officially dubbed RJVA-001—has cleared preclinical testing, according to the company. The therapy aims to insert a GLP-1-secreting transgene into the organ’s beta islet cells. Fractyl said it plans to launch first-in-human trials in the first half of this year.