The RESET System Pivotal Clinical Trial (Protocol Revision K)
NCT04101669
This study is recruiting at 26 US sites in 10 states, according to its ClinicalTrials.gov record last updated .
Summary
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Diabetes type2
- Obesity
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Not applicable
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Morphic Medical Inc.
- Last updated on ClinicalTrials.gov
- October 13, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Arizona · 2
- Banner Health · Gilbert, AZ
- M3 Wake Research · Tucson, AZ
District of Columbia · 1
- MedStar Health Research Institute · Washington D.C., DC
Florida · 8
- Imagine Research · Boynton Beach, FL
- HCA Health Research Institute · Miami, FL
- UMiami · Miami, FL
- Quantum Clinical Trials · Miami Beach, FL
- Optimal Research Sites · Orange City, FL
- Orlando Health · Orlando, FL
- Denali Health Plant City · Plant City, FL
- Clinical Research Center of Florida · Pompano Beach, FL
Georgia · 3
- Denali Health Atlanta · Atlanta, GA
- Drug Studies America · Marietta, GA
- EBGS Clinical Research · Snellville, GA
Louisiana · 1
- Elevate Clinical Research, Lake Charles · Lake Charles, LA
Massachusetts · 1
- Brigham and Women's Hospital · Boston, MA
Michigan · 1
- Michigan Medicine, Division of Gastroenterology and Hepatology · Ann Arbor, MI
Minnesota · 1
- Mayo Clinic · Rochester, MN
New York · 1
- Weill Cornell Medicine · New York, NY
Texas · 7
- Elevate Clinical Research, Atascocita · Atascocita, TX
- M3 Wake Research · Dallas, TX
- Epic Medical Research · DeSoto, TX
- Care United Research · Forney, TX
- Baylor College of Medicine · Houston, TX
- Elevate Clinical Research, Houston · Houston, TX
- VAST Clinical Research · Prosper, TX
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.