RESET System Pivotal Trial (Rev F)

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Diabetes type2, Obesity

In brief

A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the RESET System for Glycemic Improvement in Patients with Inadequately Controlled Type 2 Diabetes and Obesity, the STEP-1 Study. A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the RESET System plus moderate intensity lifestyle and dietary counseling compliant with 2024 ADA Standard of Care as compared to a sham control receiving moderate intensity lifestyle and dietary counseling. Both the treatment and sham group will practice medical management compliant with STEP-1 Study Guidelines. Patients will be randomized 3 (RESET):1 (Sham).

Key facts

Study ID

NCT04101669

Run by

Morphic Medical Inc.

People needed

264

Starts

2019-09-09

Expected to finish

2026-12-01

Last updated by the study team

2024-07-18

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥22 years and ≤ 65 years
• Have understood and signed the approved informed consent form
• Diagnosis of type 2 diabetes
• HbA1c ≥ 7.5% and ≤10%
• BMI ≥30kg/m2 and ≤ 50kg/m2
• Willing and able to comply with study requirements
• Documented negative pregnancy test in women of childbearing potential
• Women of childbearing potential not intending to become pregnant (continue to be on an approved form of birth control) for the duration of their trial participation, including post explant period. Women of child-bearing age without known sterilization will be placed on 1 form of birth-control to prevent unwanted pregnancies
• At least one year of medical records available, including detailed medical therapy and dosing information
• Failed to achieve adequate HbA1c reduction (<7.5%) after dual therapy for at least 3-month stable dosage of diabetes medication(s), including insulin, metformin, SGLT-2 inhibitor, GLP-1 RA, Dual GLP-1/GIPR agonist or, other medications including meglitinides, sulfonylureas, thiazolidinediones, or DPP-4s.

You may not qualify if…

• Previous treatment with the RESET System
• Previous GI surgery that could preclude the ability to place the RESET Liner or affect the function of the RESET Liner, or abnormal GI anatomical finding that could preclude the ability to place the RESET Liner or affect the function of the RESET Liner
• Hypoglycemia and/or DKA/HHNK in the last 6 months requiring 3rd party assistance
• Known history of liver disease (e.g., viral or autoimmune etiology, METAVIR grade 2 or higher fibrosis/cirrhosis from a biopsy within the past 6 months, but not including incidental fatty liver)
• eGFR of less than 45 ml/min/1.73 m2
• Prior history of an abscess requiring hospitalization, intravenous antibiotics or drainage
• Previous treatment for severe liver disease and/or biliary tract disease, including but not limited to, surgery, bile duct dilatation, and stent placement
• Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis
• Fasting C-peptide < 1.0 ng/mL
• Triglyceride level > 600 mg/dL
• Vitamin D deficiency (<20ng/ml)
• Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy
• Height < 5 feet (152.4 cm)
• Current alcohol addiction, current drug addiction or usage, of drugs such as, narcotics, opiates, or benzodiazepines and other addictive tranquilizers
• History of pancreatitis, including gallstone related pancreatitis (subsequent to which patient has cholecystectomy)
• Diagnosis of osteopenia or osteoporosis or currently taking denosumab, romosozumab-aqqg, bisphosphonates or teriparatide
• Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma)
• Active or recent (less than 12 months) gastroesophageal reflux disease (GERD) unless treated with H2RAs not PPI.
• Uncontrolled thyroid disease, including a history of thyroid cancer, hyperthyroidism, or taking thyroid hormone for any reason other than primary hypothyroidism (TSH level must be between 0.4-4)
• Currently taking prescription antithrombotic therapy (e.g. anticoagulant or antiplatelet agent) within 10 days prior to randomization and/or there is a need or expected need to use during the trial 9 months post implant procedure
• Currently taking the following medications (within 30 days prior to randomization) and/or there is a need or expected need to use these medications during the trial 12 months post index procedure:
• Restricted Medications/Supplements Systemic corticosteroids Proton Pump Inhibitor (PPI) Drugs known to affect GI motility (e.g.metoclopramide) Prescription or over-the-counter weight loss medication(s) Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), aspirin, ibuprofen, and other anti-inflammatory medication for study duration Medications known to cause significant weight gain or weight loss (e.g. chemotherapeutics)
• Supplements that are known or suspected to increase bleeding risk including but not limited to:
• Gingko biloba Ginseng Vitamins C \& E Turmeric St. John's wort Evening primrose oil Feverfew Green Tea Extract
• Active H. pylori

Where it is running

• MedStar Health Research Institute — Washington D.C., District of Columbia, United States (enrolling)
• University of Miami Hospital — Miami, Florida, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Michigan Medicine, Division of Gastroenterology and Hepatology — Ann Arbor, Michigan, United States (enrolling)
• Weill Cornell Medicine — New York, New York, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Baylor College of Medicine — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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