Fractyl Health's Revita reduces post-GLP-1 weight regain by ~70%

Metabolic therapeutics company Fractyl Health released midpoint data today showing its lead product, Revita, helped patients maintain weight loss for 6 months after discontinuing GLP-1 therapy.

Revita -- an outpatient endoscopic procedure targeting the root cause of obesity -- reduced post-GLP-1 weight regain by about 70% after half a year in patients with above-median weight loss, compared to a sham procedure, the company announced.

Patients who were treated with the procedure regained 4.5% of their weight, while those who received the sham procedure regained 7.5% after 6 months. However, the ongoing REMAIN-1 midpoint cohort study only includes 35 patients.

"What is particularly compelling about these six-month data is the consistency of the metabolic signal," Dr. Adarsh Thaker, M.D., Assistant Professor of Medicine, David Geffen School of Medicine at UCLA, said in the press announcement.

Patients treated with Revita had better cardiometabolic lipid profiles after 6 months, including a higher "good" cholesterol and a lower triglyceride-to-HDL ratio. They also experienced notable reductions in sweet-food cravings, Fractyl said.

Revita also showed "excellent safety and tolerability" throughout the six-month study, with no serious side effects associated with the procedure or the device, according to the company. Notably, none of the study's participants dropped out due to adverse events either.

"These pilot study results build on our prior clinical experience and represent another important validation and step toward establishing Revita as a potential first-in-class therapy for post-GLP-1 weight maintenance," Harith Rajagopalan, M.D., Ph.D., Co-Founder and CEO of Fractyl Health, also said in the release.

Despite the positive mid-phase data announcement, the readout results seemed to fall short of the expectations of investors, sending the company's stock spiraling.

Fractyl said it is moving forward with its REMAIN-1 weight-maintenance program and is slated to hit several developmental milestones this year, the company noted.

Given Revita's encouraging safety and tolerability data, Fractyl has asked the agency to consider reclassifying Revita under the De Novo pathway instead of a premarket approval, with feedback expected in the second quarter of 2026.

Topline results from the REMAIN-1 pivotal cohort are expected to be released in the second half of 2026, with a possible FDA filing to follow, the company said.

In 2024, the FDA granted a Breakthrough Device designation to Fractyl's Revita System for post-GLP-1 weight maintenance in adults with obesity, but it remains under investigation in the United States. Revita has already received approval for patient use in the European Union and the United Kingdom.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.