A simple outpatient procedure currently used for type 2 diabetes patients in Europe can help those on Eli Lilly’s obesity drug tirzepatide keep most of their weight off when stopping the med.
Weight rebound is a major issue for most patients when coming off GLP-1 drugs like Novo Nordisk’s Wegovy (semaglutide) or Lilly’s Zepbound (tirzepatide).
A meta analysis of 48 studies published in the Lancet just last month showed that: “At 1-year post-cessation [of GLP-1s], 60% of the weight lost during treatment was regained.”
Several biopharmas are looking to try and stop this weight regain—but instead of a new drug, a procedure known as duodenal mucosal resurfacing may help.
This is a minimally invasive, endoscopic, outpatient process designed to improve glycemic control in patients with type 2 diabetes by rejuvenating the lining of their small intestines.
It is currently used in Europe under the moniker Revita DMR System and sold by Fractyl Health, though it is not approved in the U.S.
Fractyl Health is now looking to expand the procedure into weight loss and has posted an early look from a cohort of patients in the ongoing 300-patient REMAIN-1 trial who have used tirzepatide.
In the trial’s initial cohort, 29 patients underwent resurfacing and 16 received a sham procedure, with all having lost at least 15% of total body weight using tirzepatide before stopping the drug.
Patients lost around 40 pounds on GLP-1 therapy. Six months after discontinuing tirzepatide, those in the REMAIN-1 trial cohort who had the sham procedure regained 40% more weight than those in the treatment group.
Patients who had more tissue resurfaced regained seven pounds, the data showed, maintaining more than 80% of their weight loss, while the sham control group regained around double that amount.
“What’s particularly encouraging is that the benefit appears to increase over time rather than fade, and that it behaves like a drug in terms of dose response,” lead author Shelby Sullivan, M.D., professor of medicine, Dartmouth Geisel School of Medicine, said in an April 23 release.
A full presentation of these latest data will be held at Digestive Disease Week in early May.
Meanwhile, topline six-month pivotal cohort data are slated to come by Q4, with “a planned marketing submission later in the year,” according to a statement.
