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

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus, Type2diabetes, Diabetes Mellitus, Type 2, Diabetes, Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT06267391

Run by

Endogenex, Inc.

People needed

350

Starts

2024-05-01

Expected to finish

2027-10-01

Last updated by the study team

2026-08-05

Who can join

Age: 22 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

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-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.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Central Alabama Research — Birmingham, Alabama, United States
• Velocity Clinical Research, Gardena — Gardena, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• UCLA — Los Angeles, California, United States
• Hoag Memorial Hospital Presbyterian - Digestive Health Institute — Newport Beach, California, United States
• Velocity Clinical Research, Hallandale Beach — Hallandale, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Universal Axon Clinical Research LLC — Miami, Florida, United States
• University of Miami — Miami, Florida, United States
• Quantum Clinical Research — Miami Beach, Florida, United States
• West Orange Endocrinology — Ocoee, Florida, United States
• Advent Health — Orlando, Florida, United States
• Orlando Health — Orlando, Florida, United States
• Health Synergy Clinical Research — West Palm Beach, Florida, United States
• NorthShore University Health System — Evanston, Illinois, United States
• Heartland Medical Research, Inc. — Clive, Iowa, United States
• Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
• John Hopkins — Baltimore, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Cooper Health System — Camden, New Jersey, United States
• Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• The Ohio State University- Wexner Medical Center — Columbus, Ohio, United States
• Velocity Clinical Research - Austin — Austin, Texas, United States
• Dell Medical School — Austin, Texas, United States

Full record on ClinicalTrials.gov

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