Adults maintain drops in body weight, HbA1c at 1 year after duodenal mucosal resurfacing
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Key takeaways:
- Adults with obesity and type 2 diabetes had a mean 14 kg reduction in body weight 1 year after undergoing Revita.
- HbA1c declined from 9.6% at baseline to 7.2% at 1 year.
Adults with obesity and type 2 diabetes had reductions in body weight and HbA1c 1 year after undergoing an endoscopic procedure that resurfaces the duodenum lining, according to top-line results from a real-world registry study.
As Healio previously reported, a duodenal mucosal resurfacing intervention (Revita, Fractyl Health) received FDA breakthrough device designation for adults with insulin-treated type 2 diabetes as well as for weight loss maintenance among adults who lost weight with GLP-1 therapy. Initial findings from Fractyl Health’s German real-world registry showed the first 11 adults who underwent Revita and completed a 1-year follow-up (median age, 62 years) had a mean 14 kg reduction in body weight and 2.4-percentage point decrease in HbA1c from baseline.
“These are compelling initial results for one of the hardest to treat patient populations —older people living with obesity and uncontrolled type 2 diabetes,” Stephan Martin, MD, professor and director of the West German Diabetes Center of Excellence in Düsseldorf, said in a press release. “These 1-year post-procedure data confirm and build upon what we have seen from Revita in earlier clinical studies. What I am most impressed with is the magnitude of continued, sustained weight loss and blood sugar improvement these patients experienced despite multiple prior efforts via other means. This contrasts with the diminishing effectiveness of medicines over time due to non-adherence and other real-world issues.”
The 11 adults who underwent the Revita procedure had a median body weight of 111 kg at baseline, a median BMI of 32 kg/m2, and a median HbA1c of 9.6% despite using as many as three glucose-lowering medications. Median body weight decreased to 101 kg at 3 months, 100 kg at 6 months and 97 kg at 12 months. HbA1c declined from 9.6% at baseline to 7.1% at 3 months. The decline in HbA1c was maintained at 7.6% at 6 months and 7.2% at 12 months.
Ten of the 11 participants maintained or decreased the number of glucose-lowering medications they were taking at 12 months. No procedure-related adverse events were observed.
There have been 37 adults treated with Revita in Germany, of whom 31 have opted to participate in the real-world study. Fractyl Health plans to continue sharing registry data and clinical outcomes as it becomes available, according to the release.
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