Procedure Shows Promise for Sustained Weight Loss After GLP-1 Therapy
Revita is a procedure that modifies duodenal dysfunction and restores metabolic health, according to Fractyl Health.
Positive 3-month data from the REVEAL-1 cohort in the REMAIN-1 study suggest that Revita could help people maintain their weight loss or lose additional weight following the discontinuation of glucagon-like peptide-1 (GLP-1) receptor agonists. Revita is a procedure that modifies duodenal dysfunction and restores metabolic health, according to Fractyl Health.1,2
“There is an extraordinary unmet need in obesity treatment, which is the ability for patients to stop GLP-1 drugs without regaining weight. Currently, if patients achieve successful weight loss but stop these medications, they regain lost weight and typically report a significant return of hunger, cravings, and food noise even when switching to another agent in the same class,” Shelby Sullivan, MD, professor of medicine at the Geisel School of Medicine at Dartmouth University, said in a news release.1 “These early Revita data are better than I expected and suggest the potential to prevent the weight regain we see in practice. If these findings are sustained beyond 3 months and validated in the randomized cohort, this could become a viable solution for the many patients who would like to stop GLP-1 medications but currently can’t.”
The study is an open-label cohort trial aimed at evaluating the safety, tolerability, and early efficacy of Revita for patients who lost at least 15% or more of their total body weight with a recently discontinued GLP-1. Patients underwent a single Revita procedure and received a structured diet and lifestyle adjustments after the procedure. Investigators included 22 patients, and current 3-month data include 13 patients. There are 11 women and 2 men, with an average age of 49 years, who were previously treated with a GLP-1 for 5 months to 3 years. They also had a median total body weight loss of 20.9% while on therapy and 15% had prediabetes at baseline.1
In early data, there were no safety or tolerability concerns for the patients, which was consistent with a safety profile from more than 100 other patients. At 1-month postprocedure, 7 patients had an average weight regain of 1.2% compared with the normal 3% that is seen after discontinuing a GLP-1 medication.2
In the news analysis, 12 of 13 patients either lost or maintained weight after the procedure at 3 months, and 6 of 13 had further weight loss. The median weight was stable through 3 months compared with the typical 10 to 15 pound rebound that was seen in the SURMOUNT-4 trial. Only 1 patient had a similar weight regain. Further, from 1 month to 3 months, there was little to no weight change, with a median weight gain at 1 month being 0.43% compared with 0.46% at 3 months.1
Furthermore, the procedure was well tolerated and had no unanticipated or serious adverse effects, remaining consistent with safety concerns.1
“These REVEAL-1 cohort data represent a powerful early signal of Revita’s ability to sustain weight loss after GLP-1 therapy ends, which is a significant challenge in the obesity treatment landscape,” Harith Rajagopalan, MD, PhD, co-founder and CEO of Fractyl Health, said in a news release.1 “With over 90 percent of patients maintaining or continuing to lose weight after a single Revita procedure, we believe Revita may be uniquely positioned to define a new therapeutic area in metabolic care: post-GLP-1 weight maintenance.”
Investigators expect midpoint data in the third quarter of 2025 and 6-month data in the second half of 2026.1
