AzTrials
AzTrials

Diabetes type2STEP-1NCT04101669

The RESET System Pivotal Clinical Trial (Protocol Revision K)

A study testing RESET Liner in people with Diabetes type2 and Obesity, run by Morphic Medical Inc. at 27 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 22 to 65 years
Conditions the study is for
Diabetes type2, Obesity
What is being tested?
RESET Liner
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
264 participants
Where
27 sitesUnited States
Study dates
9 Sep 2019to 30 Sep 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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
Show all 36Show fewer
  • 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
  • History of Crohn's disease, atresias or untreated stenoses
  • Abnormal pathologies or conditions of the gastrointestinal tract, including ulcers or upper gastrointestinal bleeding conditions within 3 months of randomization
  • Patients may be disqualified for study inclusion for any condition determined by the PI that places patient at undue risk.
  • Poor dentition not allowing complete chewing of food
  • Enrolled in another investigational study within 3 months of screening for this study (enrollment in observational studies is permitted)
  • Residing in a location without ready access to study site medical resources
  • Documented weight loss of 5% total body weight (TBW) anytime during the 3 months preceding randomization
  • Positive Fecal Immunochemical Test (FIT)
  • History or observation of psychological disorder or behavior which could preclude compliance to the treatment and follow up plan
  • No access to an active telephone and internet service for provision of Follow Up Schedule calls and electronic diary
  • 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
  • Any condition that increases red cell turnover, such as thalassemia
  • 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)

Trial locations and contacts

27 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Aoife Devery, MA contact

617.528.8880

adevery@morphicmed.com

Lina Ginneti, BS contact

617.216.6699

lginnetti@morphicmed.com

27 sites in 1 country

United States27 sites, 27 recruiting

  • Michigan Medicine, Division of Gastroenterology and Hepatology

    Ann Arbor, Michigan, 48109

    Spring Stonebraker, 734-615-6258, sprstone@med.umich.edu

    Allison R Schulman, MD

    Recruiting

  • Elevate Clinical Research, Atascocita

    Atascocita, Texas, 77346

    Shalina Wells, 4693401433, Shalina.Wells@elevateclinical.com

    Maria Berdayes, MD

    Recruiting

  • Denali Health Atlanta

    Atlanta, Georgia, 30083

    Maryam Bintumar, (404) 999-2734, maryam@denali-health.com

    Maria Johnson

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Delaney Mahan, MS, 617-525-8266, dmanahan@bwh.harvard.edu

    Christopher C Thompson, MD

    Recruiting

  • Imagine Research

    Boynton Beach, Florida, 33435

    Zachary M Weiss, Zachary@imagineresearch.com

    Aaron Cohen, MD

    Recruiting

  • M3 Wake Research

    Dallas, Texas, 75224

    Vicki Martinez, vmartinez@wakeresearch.com

    Carlos Arauz-Pacheco, MD

    Recruiting

  • Epic Medical Research

    DeSoto, Texas, 75115

    Josie Propheter, 9302324376, jquemado@epicmedresearch.com

    Haresh Boghara, MD

    Recruiting

  • Care United Research

    Forney, Texas, 75126

    Caroline Woodruff, 972-564-0044, caroline.woodruff@careunitedresearch.com

    Shilpi Mittal, MD

    Recruiting

  • Banner Health

    Gilbert, Arizona, 85234

    Bethany Kerr, (480) 649-6600, Bethany.Kerr2@bannerhealth.com

    Neil Sharma, MD

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Haydee Rochits, 713-798-0950, BCM-RESET@bcm.edu

    Wasif M Abidi, MD

    Recruiting

  • Elevate Clinical Research, Houston

    Houston, Texas, 78504

    Jennifer Keane, (832) 240-9765, jennifer.keane@elevateclinical.com

    Joe Pouzar, MD

    Recruiting

  • Elevate Clinical Research, Lake Charles

    Lake Charles, Louisiana, 70605

    Ashley Pennington, 4693401433, ashley.pennington@elevateclinical.com

    Francisco Marrero, MD

    Recruiting

  • Drug Studies America

    Marietta, Georgia, 30060

    Tanya Astorga, 470-535-9379, tastorga@drugstudies.net

    Glenn Gatipon, MD

    Recruiting

  • HCA Health Research Institute

    Miami, Florida, 33140

    Ana Portela, 786-457-7672, ana.portela@hcahealthcare.com

    Nestor De La Cruz, MD

    Recruiting

  • UMiami

    Miami, Florida, 33143

    Giana Ilarraza, 305-689-1910, gni4@med.miami.edu

    Robert Cubas

    Recruiting

  • Quantum Clinical Trials

    Miami Beach, Florida, 33140

    Nicole Burgos, 955-375-2235, nicole@qctrials.com

    George Azar, MD

    Recruiting

  • Weill Cornell Medicine

    New York, New York, 10021

    Veronika Solomon, ves4012@med.cornell.edu

    Reem Sharaiha, MD

    Recruiting

  • Optimal Research Sites

    Orange City, Florida, 32763

    Claxton Copeland, (386) 218-5911, claxton.copeland@optimalresearchsites.net

    Kristyna Paradis, MD

    Recruiting

  • Orlando Health

    Orlando, Florida, 32806

    Leticia Morales, 321-843-8910, Leticia.Morales@orlandohealth.com

    Andre Texeira, MD

    Recruiting

  • Denali Health Plant City

    Plant City, Florida, 33563

    Maryam Bintumar, (217) 933-2108, maryam.bintumar@orlandohealth.com

    Luis Aponte, MD

    Recruiting

  • Clinical Research Center of Florida

    Pompano Beach, Florida, 33060

    Cassandra Bravo, 954-372-2209, cassandra@floridacrc.com

    Howard Koch, MD

    Recruiting

  • VAST Clinical Research

    Prosper, Texas, 75078

    Bukola Adaramola, bukolaa@vastclinicalresearch.com

    Uchenna Ozuah

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Abigail Stromme, (507) 284-2511, Stromme.Abigail@mayo.edu

    Dan Maselli, MD

    Recruiting

  • EBGS Clinical Research

    Snellville, Georgia, 30078

    Cheyenne Head, cheyenne@esbariatricandgeneralsurgery.com

    Aliu Sanni, MD

    Recruiting

  • M3 Wake Research

    Tucson, Arizona, 85710

    Namrata Oza, 520-230-1372, noza@wakeresearch.com

    David Alster, MD

    Recruiting

  • MedStar Health Research Institute

    Washington D.C., District of Columbia, 20010

    Temesgen Atew, 202-877-5819, Temesgen.A.Atew@medstar.net

    John Brebbia, MD

    Recruiting

  • Health Synergy Clinical Research

    West Palm Beach, Florida, 33407

    Michael Maresca, mmaresca@hscresearch.com

    Robert Dudley, MD

    Not yet recruiting

Other trials in United States

About this study

Official title: 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

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).

Read the detailed description

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
Being tested
RESET Liner, Sham
Keywords
Type 2 Diabetes, Obesity
Medical subject headings
Obesity, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RESET LinerDevice

    Also called RESET Sleeve, Duodenal-jejunal Bypass Liner (DJBL), EndoBarrier

    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.

  • ShamOther

    Patient receives upper endoscopy but no treatment

Study groups in NCT04101669
Study groupRoleWhat they receive
RESET Treatment ArmExperimentalPatients in ARM 1, will receive an upper endoscopy and will be treated with the RESET Liner
Receives: Device: RESET Liner
Sham Control ArmSham comparatorPatients in Arm 2 will receive an upper endoscopy, but will not be treated with the RESET Liner.
Receives: Other: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

    Change in HbA1c value from baseline to 9 months.

    Measured: 9 Months

  2. SAE Rate

    Incidence of serious adverse events

    Measured: 9 months

Secondary outcomes (7)

  1. HbA1c Reduction

    Proportion of patients who achieve an HbA1c reduction ≥0.5%

    Measured: 9 and 21 months

  2. Weight Loss

    Proportion of patients who achieve percent total body weight loss ≥ 5% from baseline

    Measured: 9 and 21 months

  3. Insulin use

    Reduction in percentage insulin units per day

    Measured: 9 and 21 months

  4. Fasting blood glucose level

    Reduction in fasting blood glucose values

    Measured: 9 and 21 months

  5. Diabetes Treatment Satisfaction Questionnaire

    Change from baseline in treatment satisfaction using Diabetes Treatment Satisfaction Questionnaire (DTSQ) (0-6, 0=Very dissatified, 6=Very satisfied)

    Measured: 9 and 21 months

  6. Impact of Weight on Quality of Life

    Impact of weight on quality of life (IWQOL) questionnaire change from baseline (0-100, 0=Worst, 100=Best quality of life)

    Measured: 9 and 21 months

  7. EQ-5D

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

    Measured: 9 and 21 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2019
  2. Study start9 Sep 2019
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the RESET System. Patients will be randomized 3 (RESET):1 (Sham).
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
264 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04101669
Sponsor's protocol ID
18-1
Acronym
STEP-1
Status last verified
Oct 2026
First submitted
20 Sep 2019
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008 Oct 9;359(15):1577-89. doi: 10.1056/NEJMoa0806470. Epub 2008 Sep 10.

    PubMed 18784090

  • Rodbard D. Interpretation of continuous glucose monitoring data: glycemic variability and quality of glycemic control. Diabetes Technol Ther. 2009 Jun;11 Suppl 1:S55-67. doi: 10.1089/dia.2008.0132.

    PubMed 19469679

  • Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, Hadden D, Turner RC, Holman RR. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000 Aug 12;321(7258):405-12. doi: 10.1136/bmj.321.7258.405.

    PubMed 10938048

  • Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):854-65.

    PubMed 9742977

  • Ford ES, Li C, Little RR, Mokdad AH. Trends in A1C concentrations among U.S. adults with diagnosed diabetes from 1999 to 2004. Diabetes Care. 2008 Jan;31(1):102-4. doi: 10.2337/dc07-0565. Epub 2007 Oct 12. No abstract available.

    PubMed 17934146

  • Detournay B, Cros S, Charbonnel B, Grimaldi A, Liard F, Cogneau J, Fagnani F, Eschwege E. Managing type 2 diabetes in France: the ECODIA survey. Diabetes Metab. 2000 Nov;26(5):363-9.

    PubMed 11119015

  • Mokdad AH, Ford ES, Bowman BA, Dietz WH, Vinicor F, Bales VS, Marks JS. Prevalence of obesity, diabetes, and obesity-related health risk factors, 2001. JAMA. 2003 Jan 1;289(1):76-9. doi: 10.1001/jama.289.1.76.

    PubMed 12503980

  • Torquati A, Lutfi R, Abumrad N, Richards WO. Is Roux-en-Y gastric bypass surgery the most effective treatment for type 2 diabetes mellitus in morbidly obese patients? J Gastrointest Surg. 2005 Nov;9(8):1112-6; discussion 1117-8. doi: 10.1016/j.gassur.2005.07.016.

    PubMed 16269382

  • Rubino F, Gagner M. Potential of surgery for curing type 2 diabetes mellitus. Ann Surg. 2002 Nov;236(5):554-9. doi: 10.1097/00000658-200211000-00003.

    PubMed 12409659

  • Colditz GA, Willett WC, Rotnitzky A, Manson JE. Weight gain as a risk factor for clinical diabetes mellitus in women. Ann Intern Med. 1995 Apr 1;122(7):481-6. doi: 10.7326/0003-4819-122-7-199504010-00001.

    PubMed 7872581

  • Koh-Banerjee P, Wang Y, Hu FB, Spiegelman D, Willett WC, Rimm EB. Changes in body weight and body fat distribution as risk factors for clinical diabetes in US men. Am J Epidemiol. 2004 Jun 15;159(12):1150-9. doi: 10.1093/aje/kwh167.

    PubMed 15191932

  • Ritz E. Limitations and future treatment options in type 2 diabetes with renal impairment. Diabetes Care. 2011 May;34 Suppl 2(Suppl 2):S330-4. doi: 10.2337/dc11-s242. No abstract available.

    PubMed 21525478

  • Aschner P, Kipnes MS, Lunceford JK, Sanchez M, Mickel C, Williams-Herman DE; Sitagliptin Study 021 Group. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care. 2006 Dec;29(12):2632-7. doi: 10.2337/dc06-0703.

    PubMed 17130196

  • Bennett MC, Badillo R, Sullivan S. Endoscopic Management. Gastroenterol Clin North Am. 2016 Dec;45(4):673-688. doi: 10.1016/j.gtc.2016.07.005.

    PubMed 27837781

  • Brethauer SA, Chang J, Galvao Neto M, Greve JW. Gastrointestinal devices for the treatment of type 2 diabetes. Surg Obes Relat Dis. 2016 Jul;12(6):1256-61. doi: 10.1016/j.soard.2016.02.031. Epub 2016 Mar 2.

    PubMed 27568475

Questions about this trial

What is this clinical trial studying?

A study testing RESET Liner in people with Diabetes type2 and Obesity, run by Morphic Medical Inc. at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aoife Devery, MA (617.528.8880, adevery@morphicmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: 9 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04101669, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in