RESET System Pivotal Trial (Rev F)
Eligible age
22–65 yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
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About this study
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).
Sponsor: Morphic Medical Inc.
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Washington D.C.
Miami
Boston
Ann Arbor
New York
Cleveland
Houston
Source: ClinicalTrials.gov · NCT04101669 · last updated 2024-07-18