Condition: Diabetes type2 · Obesity · Sponsor: Morphic Medical Inc.
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).
This description comes directly from the study's public registry record.
Stephen J Linhares, BS · 774-454-3259 · slinhares@gidynamics.com
Aoife Devery, BS · 617-528-8880 · adevery@gidynamics.com
Always discuss trial participation with your own doctor first.
| MedStar Health Research Institute | Washington D.C., District of Columbia, United States | Recruiting |
| University of Miami Hospital | Miami, Florida, United States | Recruiting |
| Brigham and Women's Hospital | Boston, Massachusetts, United States | Recruiting |
| Michigan Medicine, Division of Gastroenterology and Hepatology | Ann Arbor, Michigan, United States | Recruiting |
| Weill Cornell Medicine | New York, New York, United States | Recruiting |
| Cleveland Clinic | Cleveland, Ohio, United States | Recruiting |
| Baylor College of Medicine | Houston, Texas, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04101669