ADA 2019—Duodenal mucosal resurfacing promising in interim analysis


  • Emily Willingham, PhD
  • Conference Reports
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Takeaway

  • A small trial of duodenal mucosal resurfacing (Revita DMR; Fractyl) plus drug (liraglutide) and lifestyle treatment for type 2 diabetes (T2D) has yielded promising interim results.
  • Of 13 patients who reached 6-month follow-up, 85% are insulin-independent.
  • Liver fat content also had decreased by 45%, and BP and weight improved.

Why this matters

  • DMR is a same-day endoscopic procedure that leaves the duodenal mucosa ablated, altering metabolic signaling, says Fractyl. 
  • The company has conducted clinical studies involving 200 patients, with results suggesting improvements up to 1 year in blood glucose, liver fat, cardiovascular risk, weight loss, without lifestyle intervention.

Key results

  • 11/13 patients (85%) who reached 6-month follow-up are insulin-independent.
  • The other 3 of the original 16 enrollees have not yet reached 6 months.
  • Liver fat decreased on average by 45% (baseline was 8.5% liver fat).
  • The company says that the safety profile is acceptable and DMR was well-tolerated.

Study design

  • Single-center study, 16 participants with T2D.
  • Participants underwent DMR, discontinued insulin.
  • At day 14, they began liraglutide (titration to 1.8 mg/day).
  • Lifestyle counseling provided throughout.
  • Endpoint: percentage insulin-free, HbA1c ≤59 mmol/mol at 6 months.
  • Funding: Fractyl, others.

Limitations

  • Conference presentation, very small study population, no control group.