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Type 2 Diabetes MellitusNCT06267391

Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes

A study testing Endogenex Treatment in people with Type 2 Diabetes Mellitus and Type2diabetes, run by Endogenex, Inc. at 44 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications. Read more about this study

Who is it for?
Ages 22 to 70 years
What is being tested?
Endogenex Treatment
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
350 participants
Where
44 sitesin 2 countries
Study dates
1 May 2024to 1 Oct 2027
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 22- 70 years of age, inclusive.
  • T2D diagnosis for at least 6 months.
  • HbA1C of 7.5-10.5%, inclusive, determined by the central laboratory.
  • BMI 27-40 kg/m2, inclusive.
  • On 2-4 non-insulin glucose lowering mediations or on monotherapy with either GLP-1 or GLP-1/GIP medications, with no changes in medication or dosing for at least 12 weeks prior to the baseline visit.
  • Individualized metabolic surgery (IMS) score ≤ 95.
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  • Weight stability (≤5% weight change) 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 not pregnant and using an acceptable method of contraception throughout the study.
  • Willing and able to comply with study visits and study tasks as required per protocol.

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 41Show fewer
  • Discontinuation of a GLP-1RA or a GLP-1/GIP dual-agonist within 6 months of the screening visit following at least one month of treatment.
  • Known autoimmune disease, including but not limited to, celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder, or as evidenced by a positive anti-glutamic acid decarboxylase (GAD) test.
  • 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 eosinophilic esophagitis, stricture/stenosis, varices, diverticula, or other disorder of the esophagus, stomach and duodenum.
  • History of gastroparesis.
  • Acute gastrointestinal illness in the last 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.
  • Active hepatitis or active liver disease, or alanine aminotransferase (ALT) level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory at screening visit. Patients with NAFLD are eligible if their ALT level is ≤3.0 times the ULN.
  • Current use of vitamin K antagonists, such as warfarin, or current use of direct-action oral anticoagulants (DOCAs) that cannot be safely discontinued periprocedurally.
  • Current use of P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued for 7 days before the procedure.
  • Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) from treatment through 4 weeks following the procedure. Alternative use of acetaminophen and low dose aspirin is allowed.
  • Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 12 weeks prior to the screening visit.
  • Use of medications known to affect GI motility (e.g. metoclopramide/ Reglan)
  • Current use of weight loss medications such as Saxenda [liraglutide ], Xenical® [orlistat], Acutrim® [phenylpropanolamine], Sanorex® [mazindol], Adipex® [phentermine], BELVIQ® [lorcaserin], Qsymia® [phentermine/topiramate combination], Contrave® [naltrexone/bupropion], or other weight loss medications including over-the-counter [OTC] medications [for example, Allī®]) or have discontinued weight loss medications within 6 months.
  • Participation in any structured weight loss program or endoscopic weight loss intervention within 6 months of the screen visit.
  • 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 prior to the Screening Visit.
  • Unstable or paroxysmal cardiac arrhythmia.
  • Any of the following cardiovascular conditions within 6-months prior to screening visit: acute myocardial infarction, cerebrovascular accident (stroke), hospitalization due to congestive heart failure.
  • History of valvular heart disease or chronic heart failure (NYHA III or IV).
  • Estimated glomerular filtration rate (eGFR) ≤ 45 ml/min/1.73m2 calculated by CKD-EPI Creatinine Equation as determined by the central laboratory.
  • 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 (TSH value outside the normal range at screening).
  • 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.
  • Binge eating disorder, or any other mental or physical condition which, in the opinion of the study investigator, makes the participant a poor candidate for clinical trial participation.
  • 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.

Trial locations and contacts

44 sites in 2 countries.

44 sites in 2 countries

United States37 sites

  • Velocity Clinical Research - Austin

    Austin, Texas, 78613

  • Dell Medical School

    Austin, Texas, 78712

  • IMA Clinical Research - Austin

    Austin, Texas, 78745

  • John Hopkins

    Baltimore, Maryland, 21287

  • The University of Texas Health Science Center at Houston

    Bellaire, Texas, 77401

  • University of Alabama

    Birmingham, Alabama, 35205

  • Central Alabama Research

    Birmingham, Alabama, 35209

  • Cooper Health System

    Camden, New Jersey, 08103

  • Heartland Medical Research, Inc.

    Clive, Iowa, 50325

  • The Ohio State University- Wexner Medical Center

    Columbus, Ohio, 43210

  • Velocity Clinical Research, Dallas

    Dallas, Texas, 75230

  • Southwest Medical Center

    Dallas, Texas, 75235

  • University of Texas Southwestern Medical School - William P. Clements Jr. University Hospital

    Dallas, Texas, 75235

  • Epic Medical Research

    DeSoto, Texas, 75115

  • NorthShore University Health System

    Evanston, Illinois, 60201

  • Velocity Clinical Research, Gardena

    Gardena, California, 90247

  • Velocity Clinical Research, Hallandale Beach

    Hallandale, Florida, 33009

  • Houston Methodist Research Institute

    Houston, Texas, 77030

  • Juno Research, LLC

    Houston, Texas, 77054

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • UCLA

    Los Angeles, California, 90065

  • Universal Axon Clinical Research LLC

    Miami, Florida, 33166

  • University of Miami

    Miami, Florida, 33166

  • Quantum Clinical Research

    Miami Beach, Florida, 33140

  • Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

  • Hoag Memorial Hospital Presbyterian - Digestive Health Institute

    Newport Beach, California, 92663

  • West Orange Endocrinology

    Ocoee, Florida, 34761

  • Advent Health

    Orlando, Florida, 32804

  • Orlando Health

    Orlando, Florida, 32806

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Texas Diabetes & Endocrinology, P.A.

    Round Rock, Texas, 78681

  • Diabetes & Glandular Disease Clinic, P.A.

    San Antonio, Texas, 78229

  • IMA Clinical Research - San Antonio

    San Antonio, Texas, 78229

  • Mt. Olympus Medical Research

    Sugar Land, Texas, 77479

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50266

  • Health Synergy Clinical Research

    West Palm Beach, Florida, 33407

Other trials in United States

Australia7 sites

  • Eastern Health - Box Hill Hospital

    Box Hill, Victoria, 3128

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2006

  • The BMI Clinic

    Double Bay, New South Wales, 2028

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Austin Health

    Heidelberg, Victoria

  • Baker Heart and Diabetes Institute

    Melbourne, Victoria, 3004

  • Royal North Shore Hospital

    Saint Leonards, New South Wales, 2065

Other trials in Australia

About this study

Official title: A Multicenter, Randomized, Double-blind, Sham-controlled Study for Assessing the Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes (ReCET Study)

This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications.

Read the detailed description

This is a prospective, multi-center, randomized, double-blind, sham-controlled, adaptive study enrolling individuals with type 2 diabetes inadequately controlled on non-insulin glucose-lowering medications. Participants will be randomized to receive the Endogenex therapy or sham procedure consisting of device insertion without treatment. Participants will be followed for 6 months for the primary endpoint and 12 months in total. After 12 months, participants randomized to the sham arm may cross-over to receive the Endogenex procedure.

Being tested
Endogenex Treatment, Sham Procedure
Keywords
Diabetes, Type 2 Diabetes, Duodenal Mucosal Resurfacing
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

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

  • Endogenex TreatmentDevice

    Also called duodenal mucosal resurfacing

    Treatment arm will receive the Endogenex therapy. The procedure utilizes the Endogenex catheter to deliver non-thermal pulsed electric field to the first portion of the small intestine (duodenum) to induce cell regeneration. The catheter is introduced to the duodenum through the mouth using a guide wire and the therapy is applied to treat the duodenum. Participants will be followed for 12 months post procedure.

  • Sham ProcedureDevice

    The Control arm will receive a sham procedure. The sham procedure consists of placing the Endogenex catheter as described above without therapy applied. Participants will be followed for 12 months post procedure. They will be offered the Endogenex therapy after 12 months.

Study groups in NCT06267391
Study groupRoleWhat they receive
Endogenex ArmExperimentalTreatment Arm will receive the Endogenex procedure.
Receives: Device: Endogenex Treatment
Control ArmSham comparatorControl Arm will receive a sham procedure.
Receives: Device: Sham Procedure

What is being measured

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

  1. HbA1c

    Change in HbA1c (%) from baseline to Month 6

    Measured: 6 months post-procedure

Secondary outcomes (5)

  1. HbA1c

    Change in HbA1c (%) from baseline to Month 12

    Measured: 12 months post-procedure

  2. HbA1c ≤7.0% without requiring rescue medication

    Proportion of participants with HbA1c ≤7.0% without requiring rescue medication

    Measured: 6 months post-procedure

  3. Time-in Range (TIR)

    Proportion of participants with TIR ≥70%

    Measured: 6 months post-procedure

  4. Total body weight loss (%TBWL)

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

    Measured: 6 months post-procedure

  5. Incidence of adverse events

    Incidence of adverse events, device- and/or procedure-related adverse events, and serious device- and/or procedure-related adverse events, and adverse events of special interest.

    Measured: 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 posted20 Feb 2024
  2. Study start1 May 2024
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Oct 2027 (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 participants randomized in a 2:1 ratio to the treatment arm or the sham control arm.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06267391
Sponsor's protocol ID
898
Status last verified
Aug 2026
First submitted
5 Feb 2024
Last updated
5 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 Endogenex Treatment in people with Type 2 Diabetes Mellitus and Type2diabetes, run by Endogenex, Inc. at 44 sites in 2 countries.

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 11 inclusion and 41 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: 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 NCT06267391.

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 5 Aug 2026.

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