AzTrials
AzTrials

Diabetes Type 2pulsENDONCT07768631

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

A study testing pulsENDO Therapy in people with Diabetes Type 2 and Diabetes, run by Endogenex, Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 22 to 75 years
Conditions the study is for
Diabetes Type 2, Diabetes, Diabetes (DM)
What is being tested?
pulsENDO Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
No sites listed yet
Study dates
1 Jan 2027to 1 Nov 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 22- 75 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 .
Show all 12Show fewer
  • 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.

Who cannot join

  • 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
Show all 53Show fewer
  • 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)
  • Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) from treatment through 4 weeks following the procedure.
  • Use of systemic glucocorticoids for more than 10 consecutive days within 12 weeks
  • Use of medications known to affect GI motility (e.g. metoclopramide/ Reglan)
  • Current use of weight loss medications or other weight loss medications including over-the-counter [OTC] medications or have discontinued weight loss medications within 6 months.
  • Participation in any structured weight loss program or endoscopic weight loss intervention within 6 months.
  • Persistent anemia, defined as hemoglobin <10 g/dL.
  • Known history of hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
  • History of blood donation or transfusion within 3 months.
  • Unstable or paroxysmal cardiac arrhythmia.
  • Any of the following cardiovascular conditions within 6-months prior to screening visit: acute myocardial infarction, unstable angina, cerebrovascular accident (stroke), hospitalization due to congestive heart failure, or history of other significant cardiovascular disease
  • Heart failure/valvular disease: NYHA Class III or IV heart failure, or clinically significant valvular heart disease associated with symptoms or increased procedural/anesthesia risk
  • Estimated glomerular filtration rate (eGFR) ≤ 45 ml/min/1.73m2
  • Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the participant a poor candidate for clinical trial participation in the opinion of the investigator.
  • History of secondary hypothyroidism or inadequately controlled primary hypothyroidism
  • Presence of any implanted electronic devices that cannot be turned off during the procedure
  • Presence of duodenal or biliary stents.
  • Not a candidate for upper GI endoscopy or general anesthesia.
  • Active illicit substance abuse or alcoholism (>2 drinks/day regularly).
  • Active malignancy within the last 5 years (excluding non-melanoma skin cancers).
  • Women who are breastfeeding.
  • Participating in another ongoing clinical trial of an investigational drug or device.
  • Current or history within the past 12 months of binge eating disorder, bulimia nervosa, anorexia nervosa, or night eating syndrome.
  • Clinically significant psychiatric illness, defined as any of the following: (a) psychiatric hospitalization within the past 24 months; (b) a history of suicide attempt, or active suicidal ideation within the past 24 months; or (c) a diagnosis of schizophrenia, other psychotic disorder, or bipolar disorder that is not clinically stable on current management
  • Critically ill or has a life expectancy <5 years.
  • Are investigator site personnel directly affiliated with this study and/or their immediate family member. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
  • Additional exclusion criteria to be evaluated during the screening process:
  • HbA1c < 7.5% or > 10.5% at baseline visit.
  • Uncontrolled hyperglycemia with a glucose level >270 mg/dl (>15 mmol/L) after an overnight fast or >360 mg/dl (>20 mmol/l) in a randomly performed measurement that is confirmed by a second measurement (not on the same day) between screening and baseline visit.
  • Active systemic infection, febrile illness, or antibiotic use within 4 weeks of the Baseline visit.
  • Vaccination within 14 days of the Baseline visit.
  • Any severe hypoglycemic event since the screening visit.
  • Poorly controlled hypertension, as evidenced by a mean of 3 separate blood pressure measurements >180 mmHg (systolic) or >100 mmHg (diastolic)
  • Women of child-bearing potential with a positive urine pregnancy test at baseline visit.
  • LA Grade C or greater esophagitis on endoscopy.
  • Abnormalities of the GI tract preventing endoscopic access to the duodenum.
  • Anatomic abnormalities in the duodenum or proximal jejunum that would preclude the completion of the treatment procedure, including tortuous anatomy.
  • Endoscopic observation of upper gastrointestinal abnormalities such as ulcers, polyps in the area to be treated, varices, strictures, congenital or intestinal telangiectasia.
  • Any other anatomical or endoscopic abnormalities/characteristics that, in the opinion of the investigator, would preclude safe use of the investigational device or procedure.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Marie Steinbrink Clinical Director contact

763-251-6827

msteinbrink@endogenex.com

About this study

Official title: A Prospective, Multicenter, Randomized, Sham-Controlled Study Evaluating the Metabolic Effects of pulsENDO Therapy in Adults With Type 2 Diabetes (pULSENDO Study)

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.

Read the detailed description

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 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. Participants in both cohorts are followed for 12 months post-procedure. The primary effectiveness endpoint is assessed at Month 6 in the randomized cohort.

Being tested
pulsENDO Therapy
Keywords
blinded, multicenter, randomized, doudenal regeneration, type 2 diabetes
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus, Body Weight Changes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pulsENDO TherapyDevice

    Also called Endogenex

    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.

Study groups in NCT07768631
Study groupRoleWhat they receive
pulsEndo ArmExperimentalArm to receive pulsENDO therapy
Receives: Device: pulsENDO Therapy
Sham Contorl ArmNo interventionControl arm receives sham procedure
Run-in ArmExperimentalInitial open-label run-in cohort (n=30) generates early safety data
Receives: Device: pulsENDO Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

    Change in HbA1c from baseline to Month 6

    Measured: From baseline to 6 months post-procedure

Secondary outcomes (4)

  1. Percent Change in HbA1c from baseline to Month 12

    Percent Change in HbA1c from baseline to Month 12 in treatment arm only

    Measured: Baseline to Month 12

  2. Number o participants with HbA1c ≤7.0% at Month 6

    Proportion of participants achieving HbA1c ≤7.0% without requiring rescue medication at Month 6

    Measured: Measured at Month 6 post-procedure

  3. Time-in Tight Range (TITR) at Month 6

    Number of participants with Time-in Tight Range (TITR) ≥50% at Month 6

    Measured: Measured at 6 Months post-procedure

  4. Total body weight loss (%TBL)

    Percent total body weight loss (%TBWL) from baseline to Month 6

    Measured: Measure of change from baseline to 6 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2026
  2. Study start1 Jan 2027 (estimated)
  3. Primary completion1 Nov 2029 (estimated)
  4. Study completion1 Nov 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07768631
Sponsor's protocol ID
1754
Acronym
pulsENDO
Status last verified
Aug 2026
First submitted
11 Aug 2026
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing pulsENDO Therapy in people with Diabetes Type 2 and Diabetes, run by Endogenex, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 53 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marie Steinbrink Clinical Director (763-251-6827, msteinbrink@endogenex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: From baseline to 6 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07768631.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in