Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

The RESET System Pivotal Clinical Trial (Protocol Revision K) (STEP-1)

7 de octubre de 2026 actualizado por: Morphic Medical Inc.

Un estudio aleatorizado, multicéntrico, fundamental de eficacia y seguridad que evalúa el sistema EndoBarrier® para la mejora de la glucemia en pacientes con diabetes tipo 2 y obesidad controladas de manera inadecuada

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).

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

The objective of this study is to evaluate the safety and effectiveness of the RESET System when used with moderate intensity lifestyle and dietary counseling and medical management, in patients with baseline HbA1c ≥ 7.5% and ≤10%, and BMI ≥ 30 kg/m2 and ≤ 50kg/m2, whose diabetes medications consist of at least dual therapy for 3 months, yet have not achieved adequate HbA1c control (<7.5%).

Specific objectives of this study are:

  1. To determine if the RESET System significantly improves glycemic control
  2. To determine that the RESET System can be safely used to improve glycemic control

Tipo de estudio

Intervencionista

Inscripción (Estimado)

264

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Estados Unidos
    • Arizona
      • Gilbert, Arizona, Estados Unidos, 85234
        • Reclutamiento
        • Banner Health
        • Investigador principal:
          • Neil Sharma, MD
        • Contacto:
      • Tucson, Arizona, Estados Unidos, 85710
        • Reclutamiento
        • M3 Wake Research
        • Contacto:
        • Investigador principal:
          • David Alster, MD
    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20010
        • Reclutamiento
        • MedStar Health Research Institute
        • Investigador principal:
          • John Brebbia, MD
        • Contacto:
    • Florida
      • Boynton Beach, Florida, Estados Unidos, 33435
        • Reclutamiento
        • Imagine Research
        • Investigador principal:
          • Aaron Cohen, MD
        • Contacto:
      • Miami, Florida, Estados Unidos, 33140
        • Reclutamiento
        • HCA Health Research Institute
        • Contacto:
        • Investigador principal:
          • Nestor De La Cruz, MD
      • Miami, Florida, Estados Unidos, 33143
        • Reclutamiento
        • UMiami
        • Contacto:
          • Giana Ilarraza
          • Número de teléfono: 305-689-1910
          • Correo electrónico: gni4@med.miami.edu
        • Investigador principal:
          • Robert Cubas
      • Miami Beach, Florida, Estados Unidos, 33140
        • Reclutamiento
        • Quantum Clinical Trials
        • Investigador principal:
          • George Azar, MD
        • Contacto:
      • Orange City, Florida, Estados Unidos, 32763
        • Reclutamiento
        • Optimal Research Sites
        • Contacto:
        • Investigador principal:
          • Kristyna Paradis, MD
      • Orlando, Florida, Estados Unidos, 32806
        • Reclutamiento
        • Orlando Health
        • Contacto:
        • Investigador principal:
          • Andre Texeira, MD
      • Plant City, Florida, Estados Unidos, 33563
        • Reclutamiento
        • Denali Health Plant City
        • Contacto:
        • Investigador principal:
          • Luis Aponte, MD
      • Pompano Beach, Florida, Estados Unidos, 33060
        • Reclutamiento
        • Clinical Research Center of Florida
        • Investigador principal:
          • Howard Koch, MD
        • Contacto:
      • West Palm Beach, Florida, Estados Unidos, 33407
        • Aún no reclutando
        • Health Synergy Clinical Research
        • Investigador principal:
          • Robert Dudley, MD
        • Contacto:
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30083
        • Reclutamiento
        • Denali Health Atlanta
        • Contacto:
          • Maria Johnson
        • Contacto:
      • Marietta, Georgia, Estados Unidos, 30060
        • Reclutamiento
        • Drug Studies America
        • Contacto:
        • Investigador principal:
          • Glenn Gatipon, MD
      • Snellville, Georgia, Estados Unidos, 30078
    • Louisiana
      • Lake Charles, Louisiana, Estados Unidos, 70605
        • Reclutamiento
        • Elevate Clinical Research, Lake Charles
        • Contacto:
        • Investigador principal:
          • Francisco Marrero, MD
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02115
        • Reclutamiento
        • Brigham and Women's Hospital
        • Investigador principal:
          • Christopher C Thompson, MD
        • Contacto:
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109
        • Reclutamiento
        • Michigan Medicine, Division of Gastroenterology and Hepatology
        • Investigador principal:
          • Allison R Schulman, MD
        • Contacto:
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
        • Reclutamiento
        • Mayo Clinic
        • Contacto:
        • Investigador principal:
          • Dan Maselli, MD
    • New York
      • New York, New York, Estados Unidos, 10021
        • Reclutamiento
        • Weill Cornell Medicine
        • Investigador principal:
          • Reem Sharaiha, MD
        • Contacto:
    • Texas
      • Atascocita, Texas, Estados Unidos, 77346
        • Reclutamiento
        • Elevate Clinical Research, Atascocita
        • Contacto:
        • Investigador principal:
          • Maria Berdayes, MD
      • Dallas, Texas, Estados Unidos, 75224
        • Reclutamiento
        • M3 Wake Research
        • Contacto:
        • Investigador principal:
          • Carlos Arauz-Pacheco, MD
      • DeSoto, Texas, Estados Unidos, 75115
        • Reclutamiento
        • Epic Medical Research
        • Investigador principal:
          • Haresh Boghara, MD
        • Contacto:
      • Forney, Texas, Estados Unidos, 75126
        • Reclutamiento
        • Care United Research
        • Contacto:
        • Investigador principal:
          • Shilpi Mittal, MD
      • Houston, Texas, Estados Unidos, 77030
        • Reclutamiento
        • Baylor College of Medicine
        • Investigador principal:
          • Wasif M Abidi, MD
        • Contacto:
          • Haydee Rochits
          • Número de teléfono: 713-798-0950
          • Correo electrónico: BCM-RESET@bcm.edu
      • Houston, Texas, Estados Unidos, 78504
        • Reclutamiento
        • Elevate Clinical Research, Houston
        • Investigador principal:
          • Joe Pouzar, MD
        • Contacto:
      • Prosper, Texas, Estados Unidos, 75078

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

22 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Age ≥22 years and ≤ 65 years
  2. Have understood and signed the approved informed consent form
  3. Diagnosis of type 2 diabetes
  4. HbA1c ≥ 7.5% and ≤10%
  5. BMI ≥30kg/m2 and ≤ 50kg/m2
  6. Willing and able to comply with study requirements
  7. Documented negative pregnancy test in women of childbearing potential
  8. 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
  9. At least one year of medical records available, including detailed medical therapy and dosing information
  10. 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.

Exclusion Criteria:

  1. Previous treatment with the RESET System
  2. 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
  3. Hypoglycemia and/or DKA/HHNK in the last 6 months requiring 3rd party assistance.
  4. 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)
  5. eGFR of less than 45 ml/min/1.73 m2
  6. Prior history of an abscess requiring hospitalization, intravenous antibiotics or drainage
  7. Previous treatment for severe liver disease and/or biliary tract disease, including but not limited to, surgery, bile duct dilatation, and stent placement
  8. Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis
  9. Fasting C-peptide < 1.0 ng/mL
  10. Triglyceride level > 600 mg/dL
  11. Vitamin D deficiency (<20ng/ml)
  12. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy
  13. Height < 5 feet (152.4 cm)
  14. Current alcohol addiction, current drug addiction or usage, of drugs such as, narcotics, opiates, or benzodiazepines and other addictive tranquilizers
  15. History of pancreatitis, including gallstone related pancreatitis (subsequent to which patient has cholecystectomy)
  16. Diagnosis of osteopenia or osteoporosis or currently taking denosumab, romosozumab-aqqg, bisphosphonates or teriparatide
  17. Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma)
  18. Active or recent (less than 12 months) gastroesophageal reflux disease (GERD), unless treated with H2Ras not PPI.
  19. 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)
  20. 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
  21. 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
  22. Active H. pylori
  23. History of Crohn's disease, atresias or untreated stenoses
  24. Abnormal pathologies or conditions of the gastrointestinal tract, including ulcers or upper gastrointestinal bleeding conditions within 3 months of randomization
  25. Patients may be disqualified for study inclusion for any condition determined by the PI that places patient at undue risk.
  26. Poor dentition not allowing complete chewing of food
  27. Enrolled in another investigational study within 3 months of screening for this study (enrollment in observational studies is permitted)
  28. Residing in a location without ready access to study site medical resources
  29. Documented weight loss of 5% total body weight (TBW) anytime during the 3 months preceding randomization
  30. Positive Fecal Immunochemical Test (FIT)
  31. History or observation of psychological disorder or behavior which could preclude compliance to the treatment and follow up plan
  32. No access to an active telephone and internet service for provision of Follow Up Schedule calls and electronic diary
  33. Having donated blood or received a blood transfusion in the 90 days prior to baseline labs. Patients should agree not to donate blood during the study
  34. Any condition that increases red cell turnover, such as thalassemia
  35. Existence of (>5 cm string test) Pseudomonas aeruginosa, Stenotrophomonas maltophilia and/or Klebsiella pneumoniae serotype K1 and K36. A known sensitivity to nickel or titanium

37. Do not meet the screening criteria for Fibroscan (i.e., Fibroscan unsafe, or Fibroscan conditional but not appropriate for the region of interest 38. History of myocardial infarction, stroke, or hospitalization for heart failure 39. History Afib and/or cardiac arrythmias 40. History of unstable angina 41.History of new or worsening signs or symptoms of CAD within the last 3 months 42.Any contraindication to general anesthesia or high risk for general anesthesia as determined by anesthesiologist (e.g., ASA score 4 or higher)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: RESET Treatment Arm

Patients in ARM 1, will receive an upper endoscopy and will be treated with the RESET Liner
Dispositivo: RESET Liner

The RESET System is provided as a single-use, sterile device and consists of an RESET Liner preloaded, packaged and sterilized within the RESET Delivery System. The RESET Delivery System is utilized to deliver the RESET Liner to the proximal small intestine. The RESET Liner is removed using the RESET Retrieval System. The RESET System incorporates no pharmacological, biological tissue or blood products.

Otros nombres:
  • Revestimiento de derivación duodenal-yeyunal (DJBL)
  • EndoBarrier
  • RESET Manga
Comparador falso: Sham Control Arm

Patients in Arm 2 will receive an upper endoscopy, but will not be treated with the RESET Liner.
Otro: Sham

Patient receives upper endoscopy but no treatment

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in HbA1c
Periodo de tiempo: 9 Months

Change in HbA1c value from baseline to 9 months.
9 Months
SAE Rate
Periodo de tiempo: 9 months

Incidence of serious adverse events
9 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
HbA1c Reduction
Periodo de tiempo: 9 and 21 months

Proportion of patients who achieve an HbA1c reduction ≥0.5%
9 and 21 months
Weight Loss
Periodo de tiempo: 9 and 21 months

Proportion of patients who achieve percent total body weight loss ≥ 5% from baseline
9 and 21 months
Insulin use
Periodo de tiempo: 9 and 21 months

Reduction in percentage insulin units per day
9 and 21 months
Fasting blood glucose level
Periodo de tiempo: 9 and 21 months

Reduction in fasting blood glucose values
9 and 21 months
Diabetes Treatment Satisfaction Questionnaire
Periodo de tiempo: 9 and 21 months

Change from baseline in treatment satisfaction using Diabetes Treatment Satisfaction Questionnaire (DTSQ) (0-6, 0=Very dissatified, 6=Very satisfied)
9 and 21 months
Impact of Weight on Quality of Life
Periodo de tiempo: 9 and 21 months

Impact of weight on quality of life (IWQOL) questionnaire change from baseline (0-100, 0=Worst, 100=Best quality of life)
9 and 21 months
EQ-5D
Periodo de tiempo: 9 and 21 months

Change from baseline in treatment satisfaction using EuroQol-5D (1-5, 1=No problem, 5=Extreme problems)
9 and 21 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
% HbA1c reduction
Periodo de tiempo: 9 and 21 months

Proportion of patients who achieve an HbA1c reduction of ≥0.5%, ≥1%, ≥1.5% and ≥2%
9 and 21 months
Total Body Weight
Periodo de tiempo: 9 and 21 months

Proportion of patients who achieve a % total body weight loss of ≥5%, ≥10%, and ≥15%
9 and 21 months
Insulin Units
Periodo de tiempo: 9 and 21 months

Proportion of patients who achieve a reduction in total number of insulin units per day of ≥25%, ≥50%, ≥75% and ≥100%
9 and 21 months
HbA1c Value
Periodo de tiempo: 9 and 21 months

Proportion of patients who achieve an HbA1c of <7%
9 and 21 months
Insulin Dosage
Periodo de tiempo: 9 and 21 months

Proportion of patients reducing insulin dosage
9 and 21 months
Non-insulin Medication use
Periodo de tiempo: 9 and 21 months

Proportion of patients reducing dosage of non-insulin diabetes medications
9 and 21 months
Cholesterol
Periodo de tiempo: 9 and 21 months

Reduction in LDL cholesterol
9 and 21 months
Triglycerides
Periodo de tiempo: 9 and 21 months

Reduction in triglycerides
9 and 21 months
Blood Pressure
Periodo de tiempo: 9 and 21 months

Reduction in systolic blood pressure values
9 and 21 months
Vitamin D Levels
Periodo de tiempo: 9 and 21 months

Changes in vitamin D levels
9 and 21 months
Vitamin D Supplementation
Periodo de tiempo: 9 and 21 months

Average vitamin D supplementation levels required to maintain normal vitamin D levels
9 and 21 months
Vitamin D Refraction
Periodo de tiempo: 9 and 21 months

Proportion of patients refractory to vitamin D supplementation
9 and 21 months
Serum Creatinine
Periodo de tiempo: 9 and 21 months

Change in serum creatinine levels
9 and 21 months
eGFR
Periodo de tiempo: 9 and 21 months

Change in eGFR levels
9 and 21 months
Serum Creatinine Levels
Periodo de tiempo: 9 and 21 months

Proportion of patients with doubling of serum creatinine levels
9 and 21 months
MAFLD - Fatty Liver
Periodo de tiempo: 9 and 21 months

Absolute and magnitude reductions in hepatic fat fraction
9 and 21 months
MASH - Liver Stiffness
Periodo de tiempo: 9 and 21 months

Reduction in liver stiffness
9 and 21 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Morphic Medical Inc.

Colaboradores

Biostatistical Consulting, Inc.

Investigadores

  • Investigador principal: Christopher C Thompson, MD, Brigham and Women's Hospital

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

9 de septiembre de 2019

Finalización primaria (Estimado)

30 de diciembre de 2027

Finalización del estudio (Estimado)

30 de septiembre de 2029

Fechas de registro del estudio

Enviado por primera vez

20 de septiembre de 2019

Primero enviado que cumplió con los criterios de control de calidad

23 de septiembre de 2019

Publicado por primera vez (Actual)

24 de septiembre de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 18-1

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir