Trial results for a study investigating a novel therapy for duodenal mucosal regeneration (Endogenex Device) for Type 2 Diabetes were posted on ClinicalTrials.gov on 2025-12-22, reporting 0 device- or procedure-related serious adverse events.
Background
Type 2 Diabetes is a chronic metabolic condition characterized by high blood sugar levels, often resulting from insulin resistance and insufficient insulin production. Managing Type 2 Diabetes typically involves lifestyle modifications and a range of medications. For patients whose condition remains inadequately controlled despite treatment with multiple non-insulin glucose-lowering medications, new therapeutic approaches are actively being explored. The Endogenex Device, designed for endoscopic duodenal mucosal regeneration, represents such a novel investigational strategy aimed at addressing the underlying metabolic dysfunction in these patients.
Trial design
This completed study, designated as Phase NA, was a multi-center, open-label trial that enrolled 20 participants. The study investigated the feasibility and preliminary safety of the Endogenex Device for endoscopic duodenal mucosal regeneration in patients with conditions including Diabetes, Diabetes Type 2, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, and Metabolic Disease. Participants were inadequately controlled on 2-3 non-insulin glucose-lowering medications. The intervention involved treatment with the Endogenex (PEF) Device. No specific primary outcomes were listed in the posted results.
Key results
The trial reported several key measurements from the interventional arm (Endogenex (PEF) Treatment):
- Participants Experiencing Device- or Procedure-Related Serious Adverse Events (SAE): 0 participants experienced related SAEs.
- Mean HbA1c by Follow-up Visit (units: HbA1c %):
- A mean of 7.2 (Standard Deviation 0.7) was observed.
- A mean of 6.7 (Standard Deviation 0.7) was observed.
- A mean of 6.9 (Standard Deviation 1.1) was observed.
- A mean of 7.0 (Standard Deviation 0.7) was observed.
- A mean of 7.2 (Standard Deviation 0.8) was observed.
- Mean Fasting Plasma Glucose (FPG) by Visit (units: mg/dL):
- A mean of 140.1 (Standard Deviation 28.6) was observed.
- A mean of 155.7 (Standard Deviation 28.8) was observed.
- A mean of 155.9 (Standard Deviation 42.7) was observed.
- A mean of 150.8 (Standard Deviation 24.2) was observed.
- A mean of 161.6 (Standard Deviation 37.0) was observed.
- Mean Weight by Follow-up Visit (units: lbs): A mean of 215.6 (Standard Deviation 38.1) was observed.
What this means
The results from this open-label study involving 20 participants suggest that the Endogenex Device for duodenal mucosal regeneration appears feasible and safe, with 0 device- or procedure-related serious adverse events reported. The observed mean HbA1c values, ranging from 6.7% to 7.2%, and mean Fasting Plasma Glucose values, ranging from 140.1 mg/dL to 161.6 mg/dL, provide preliminary insights into the glycemic impact of the intervention. While these initial findings are descriptive and lack a comparator arm for direct efficacy comparison, they contribute to understanding the potential of this novel approach for patients with Type 2 Diabetes whose condition is inadequately controlled by existing non-insulin medications.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05014204, titled "Safety and Feasibility of Novel Therapy for Duodenal Mucosal Regeneration for Type II Diabetes", were posted on 2025-12-22 on clinicaltrials.gov.