Safety and Feasibility of Novel Therapy for Duodenal Mucosal Regeneration for Type II Diabetes

NCT05014204 | Completed Results DMC FDA Device

• 1 other identifier: 346
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

This is a multi-center, open-label study to assess the feasibility and preliminary safety of the Endogenex Device for endoscopic duodenal mucosal regeneration in patients with type 2 Diabetes inadequately controlled on 2-3 non-insulin glucose-lowering medications.

Conditions

Diabetes; Diabetes Type 2; Diabetes Mellitus, Type 2; Metabolic Disease; Glucose Metabolism Disorders; Endocrine System Diseases; Diabetes Mellitus

Keywords

Endoscopy; type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Participants Experiencing Device- or Procedure-Related Serious Adverse Events (SAE)

  Number of participants experiencing device- or procedure-related serious adverse events (SAE)

  12 weeks post-procedure

Secondary Outcomes (3)

• Mean HbA1c by Follow-up Visit

  at 4,12, 24, and 48 Weeks Post Procedure

• Mean Fasting Plasma Glucose (FPG) by Visit

  Follow-up at 4,12, 24, 36, and 48 weeks post procedure

• Mean Weight by Follow-up Visit

  Follow-up at 4,12, 24, 36, and 48 weeks post procedure

Other Outcomes (2)

• Procedural Success

  At the time of procedure

• Procedural Time

  At the time of procedure

Study Arms (1)

Interventional

EXPERIMENTAL

All eligible patients will receive the endoscopic Endogenex procedure.

Device: The Endogenex Device

Interventions

The Endogenex Device DEVICE

The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field. The Endogenex procedure is a non-surgical, endoscopic procedure.

Interventional

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Current diagnosis of T2D
• History of T2D for at least 3 years and less than or equal to 10 years
• HbA1C of 7.5-10.0%, inclusive
• BMI 24-40 kg/m2, inclusive
• On two to three non-insulin glucose lowering mediations, with one at maximum tolerated dose and another at half-maximum dose at least, with no changes in medication for at least 12 weeks prior to baseline visit prior to baseline visit
• History of failed attempt to reach glycemic goal by lifestyle modifications
• Weight stability (defined as a \< 5% change in body weight) for at least 12 weeks prior to the screening visit
• Agree not to donate blood during participation in the study.
• Able to comply with study requirements and understand and sign the Informed Consent Form
• Women of childbearing potential must be using an acceptable method of contraception throughout the study
• Willing and able to use CGM for the duration of the study and comply with study visits and study tasks as required per protocol.
• Proof of COVID 19 vaccination.

You may not qualify if:

• Diagnosed with type 1 diabetes
• History of diabetic ketoacidosis or hyperosmolar nonketotic coma
• Probable insulin production failure, defined as overnight fasting C-peptide serum \<1 ng/mL (333pmol/l).
• Previous use of any types of insulin for \>1 month (at any time, except for treatment of gestational diabetes) in last 2 years.
• Current use of insulin
• Hypoglycemia unawareness
• History of ≥1 severe hypoglycemia episode (defined by needing for third-party assistance) in past 6 months from the screening visit
• Known autoimmune disease, as evidenced by a positive anti-glutamic acid decarboxylase (GAD) test, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder. (Participants with adequately controlled primary hypothyroidism may be included).
• Previous GI surgery that has changed GI anatomy or could limit treatment of the duodenum, such as Billroth 2, Roux-en-Y gastric bypass, gastric band or other similar procedures or conditions.
• Known history of a structural or functional disorder of the upper GI tract that may impede passage of the device through the upper GI tract or increase risk of tissue damage during an endoscopic procedure, including esophagitis, stricture/stenosis, varices, diverticula, or other disorder of the esophagus, stomach and duodenum.
• Active H. pylori infection (Participants with active H. pylori may continue with the screening process if they are treated with an appropriate antibiotic regimen)
• History of, or gastrointestinal symptoms suggestive of gastroparesis.
• Acute gastrointestinal illness in the previous 7 days
• Known history of irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease and Celiac disease
• History of chronic or acute pancreatitis.

Sponsors & Collaborators

• Endogenex, Inc.: lead

Study Sites (3)

University of Southern California

Los Angeles, California, 90033, United States

Location

Cuyuna Regional Medical Center

Crosby, Minnesota, 56441, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Limitations and Caveats

This pilot study was designed to assesses the initial safety of the Endogenex device in participants with type 2 diabetes. Due to the small sample size, no formal hypothesis testing was performed. Descriptive statistics are reported using mean and standard deviations.

Results Point of Contact

• Title: Chris Sorli, CMO
• Organization: Endogenex

csorli@endogenex.com

(763) 251-6820

Study Officials

• Daniel DeMarco, MD

  Baylor Scott & White

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 20, 2021
• Study Start: October 29, 2021
• Primary Completion: May 29, 2024
• Study Completion: May 29, 2025
• Last Updated: December 22, 2025
• Results First Posted: December 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)