Study Evaluating the Metabolic Effects of pulsENDO Therapy in Adults With Type 2 Diabetes

NCT07768631 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 1754
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, multicenter, randomized, double-blind, sham-controlled, adaptive study evaluating the pulsENDO system in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications (GLMs). The primary objective of this study is to demonstrate that pulsENDO therapy is superior to sham control for improving glycemic control in adults with type 2 diabetes.

Conditions

Diabetes Type 2; Diabetes; Diabetes (DM); Weight Change; Glycemic Control; Glycemic Control for Diabetes Mellitus

Keywords

blinded; multicenter; randomized; doudenal regeneration; type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change in HbA1c from baseline to Month 6

  From baseline to 6 months post-procedure

Secondary Outcomes (4)

• Percent Change in HbA1c from baseline to Month 12

  Baseline to Month 12

• Number o participants with HbA1c ≤7.0% at Month 6

  Measured at Month 6 post-procedure

• Time-in Tight Range (TITR) at Month 6

  Measured at 6 Months post-procedure

• Total body weight loss (%TBL)

  Measure of change from baseline to 6 months post-procedure

Study Arms (3)

pulsEndo Arm

EXPERIMENTAL

Arm to receive pulsENDO therapy

Device: pulsENDO Therapy

Sham Contorl Arm

NO INTERVENTION

Control arm receives sham procedure

Run-in Arm

EXPERIMENTAL

Initial open-label run-in cohort (n=30) generates early safety data

Device: pulsENDO Therapy

Interventions

pulsENDO Therapy DEVICE

The pulsENDO System is a catheter-based, non-thermal endoscopic therapy designed to promote controlled regeneration of the duodenal mucosa using pulsed electric field (PEF) technology. The treatment is controlled by the design of electrodes and waveform algorithm that concentrates the field to target the doudenal and jejunal cells of the small intestines.

Also known as: Endogenex

Run-in Arm; pulsEndo Arm

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age, inclusive.
• T2D diagnosis for at least 6 months.
• HbA1c of 7.5-10.5%, inclusive, for participants on 1-3 GLMs or or if on 4 glucose-lowering medications must have HbA1c between 7.5% - 9.0%, inclusive.
• BMI 27-40 kg/m2, inclusive.
• On 1-4 non-insulin glucose lowering medications, with no changes in medication or dosing for at least 12 weeks prior to the baseline visit
• If on lipid-lowering medications, the medication stable for at least 12 weeks .
• Individualized metabolic surgery (IMS) score ≤ 115.
• Weight stability (≤5% weight change) for at least 12 weeks
• Agree not to donate blood during participation in the study.
• Women of childbearing potential must not be pregnant and using an acceptable method of contraception throughout the study.
• Willing and able to comply with study visits and study requirements.
• Understand and able to provide written informed consent.

You may not qualify if:

• Diagnosed with type 1 diabetes.
• History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
• Fasting serum C-peptide \<1 ng/mL (333pmol/l).
• Current use of insulin, or previous use of any types of insulin for \>1 month at any time (except for treatment of gestational diabetes) in last 2 years.
• Hypoglycemic unawareness.
• History of ≥1 severe hypoglycemia episode in past 6 months
• Discontinuation of a GLP-1 or a GLP-1/GIP dual-agonist within 6 months of the screening visit following at least one month of treatment.
• Known autoimmune disease
• Previous GI surgery that has changed GI anatomy
• 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
• History of gastroparesis.
• Acute gastrointestinal illness in the last 7 days.
• Known history of inflammatory disease (e.g. Crohn's disease, ulcerative colitis, inflammatory bowel disease), radiation enteritis or other chronic inflammatory disorders of the bowel.
• History of chronic or acute pancreatitis.
• Active hepatitis or active liver disease, or alanine aminotransferase (ALT) level \>3.0 times the upper limit of normal (ULN)

Sponsors & Collaborators

• Endogenex, Inc.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Body Weight Changes

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel DeMarco, M.D.

  Baylor Health Care System

  STUDY CHAIR

Central Study Contacts

Marie Steinbrink Clinical Director

CONTACT

763-251-6827; msteinbrink@endogenex.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and Principal Investigators will be blinded to treatment status
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study enrolls two sequential cohorts. An initial open-label run-in cohort (n=30) generates early safety data to support FDA review of the pulsENDO system. This is followed by an adaptively designed randomized cohort of up to 320 participants (target 250), randomized 2:1 to pulsENDO therapy or a sham control procedure.

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 17, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2030
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share