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Type 2 DiabetesREVITALIZE 1NCT04419779

Evaluation of the Efficacy and Safety of DMR Using the Revita® in Subjects With Inadequately Controlled Type 2 Diabetes

A study testing Duodenal Mucosal Resurfacing (DMR) in people with Type 2 Diabetes, run by Fractyl Health Inc. at 58 sites in 7 countries.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

The Revita® system is being investigated to assess the efficacy of DMR versus Sham on improvement in Glycemic, Hepatic and Cardiovascular endpoints for patients with Type 2 Diabetes who are inadequately controlled on one or more glucose lowering agents. Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Duodenal Mucosal Resurfacing (DMR)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
320 participants
Where
58 sitesin 7 countries
Study dates
8 Mar 2021to Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

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 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following criteria for inclusion in the study:
  • Males and non-pregnant non-lactating females
  • Age between 21 and 70 years (both inclusive)
  • Subjects on at least one glucose lowering agent (GLA) with no changes in GLA medications or dosing for at least 12 weeks prior to the screening visit
  • Permitted GLAs include:
  • Metformin,
Show all 17Show fewer
  • GLP-1 RA including dual peptide agonists and related molecules (e.g., GLP-1/GIP RA),
  • DPP-4i,
  • TZDs,
  • SGLT2is,
  • SUs,
  • Meglitinides,
  • Insulin (basal or basal combined with short-acting), up to a total of 100 units daily
  • HbA1c of 7.5%-10% (both inclusive)
  • BMI >24 to ≤40 kg/m2
  • WOCBP should have a negative urine beta hCG pregnancy test and must agree to use two of the established contraceptive methods throughout the study duration
  • Able to sign an ICF and comply with study requirements

Who cannot join

  • Subjects who meet any of the following exclusion criteria are not allowed to be included in the study:
  • FPG ≥270 mg/dL
  • Known case of absolute insulin deficiency as indicated by clinical assessment or a fasting plasma C-peptide of <0.6 ng/mL
  • Subjects on any other class of glucose-lowering agents other than GLAs listed in inclusion criteria Any drugs or concomitant medications (e.g., psychoactive drugs such as carbamazepine phenobarbital; sympathomimetics such as ephedrine corticosteroids; anabolic steroids and male sex hormones such as testosterone) that can interfere with glucose metabolism (refer to prohibited medication on Appendix D: Eligibility Criteria Checklist)
  • Recurrent or severe urinary tract or genital mycotic infections or history of GU infection within 4 weeks prior to informed consent, for those subjects on SGLT-2
  • ALT or AST >3 times upper limit of normal (ULN) for the reference range, as determined by the central laboratory at screening visit. Patients with NAFLD are eligible if their ALT level is ≤3.0 times the ULN.
Show all 52Show fewer
  • Use of an investigational drug within 1 month or 5 half-lives (whichever is longer) before screening
  • Diagnosed with type 1 diabetes or with a recent history of DKA within one year prior to screening
  • Ketosis-prone T2D
  • Known diabetes related non-healing ulcers or amputations (with the exception of a finger or toe amputation occurring > 1 year prior to screening.
  • History of more than 1 severe hypoglycemia episode or hypoglycemia unawareness within the last 6 months
  • Clinically significant hypoglycemia occurring during the run-in period, defined as a) 2 or more glucose alert values of ≤70 mg/dL (3.9 mmol/L) unless a clear, correctable, precipitating factor can be identified; b) clinically significant hypoglycemia with self-monitored or laboratory plasma glucose level <54 mg/dL (3.0 mmol/L); or c) severe hypoglycemic episode requiring third party assistance
  • Known intestinal autoimmune disease including celiac disease, ulcerative colitis, Crohn's disease, lupus erythematosus, scleroderma, or other autoimmune connective tissue disorder that affects the small intestine
  • Secondary hypothyroidism or inadequately controlled primary hypothyroidism (thyroid stimulating hormone [TSH] value outside the normal range at screening as determined by the central laboratory).
  • Known thyroid cancer or hyperthyroidism with treatment within the past 12 months or inadequately controlled hyperthyroidism (TSH value outside the normal range at screening as determined by the central laboratory).
  • An uncontrolled endocrine condition such as multiple endocrine neoplasia (except T2D)
  • Known structural or functional disorder of the esophagus including any swallowing disorder, esophageal chest pain disorders, drug-refractory esophageal reflux symptoms, or active and uncontrolled gastroesophageal reflux disease (GERD) (defined as Los Angeles Grade C or D esophagitis)
  • Known structural or functional disorder of the stomach including active gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (a large hiatal hernia or type II and higher paraoesophageal hernia), cancer, or any other disorder of the stomach
  • Previous GI surgery that could affect the ability to treat the duodenum such as subjects who have had a Billroth 2, Roux-en-Y gastric bypass, gastric sleeve, or other similar procedures or conditions
  • Known history of chronic pancreatitis or a recent history of acute pancreatitis within the past year
  • Presence of acute or chronic active hepatitis B or C (except if hepatitis C is cured) or cirrhosis, hepatic decompensation/acute liver disease during the last 6 months, or alcoholic or autoimmune chronic hepatitis
  • Symptomatic gallstones, symptomatic kidney stones, or acute cholecystitis
  • Clinically active systemic infection
  • Known immunocompromised status including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months; have clinically significant leukopenia; are positive for the human immunodeficiency virus (HIV); are on potential immunosuppressants; or individuals whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the investigator
  • Known active malignancy or partial remission from clinically significant malignancy within the past 5 years (except basal or squamous cell skin cancer, carcinoma in situ, those who received curative treatment and are in complete remission for 5 years, or if the subject is confirmed as cancer free)
  • Known active coagulopathy or current upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, or congenital or acquired intestinal telangiectasia
  • Known cases of sickle cell anemia, thalassemia, or conditions that affect red blood cell (RBC) turnover such as a recent blood transfusion within 90 days. Current persistent anemia, defined as hemoglobin <10g/dL
  • Use of anticoagulation therapy (e.g., warfarin, coumadin, or novel oral anticoagulants [NOACs]) or anti-platelet agents (e.g., thienopyridine) which cannot be discontinued for 5-7 days or 2 drug half-lives before the procedure
  • Use of systemic glucocorticoids (excluding topical or ophthalmic applications or inhaled forms) for more than 10 consecutive days within 90 days prior to screening
  • Use of non-GLA drugs known to affect GI motility (e.g., metoclopramide)
  • Known moderate to severe chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) of <45 mL/min/1.73m2 (estimated by Modification of Diet in Renal Disease [MDRD]), end-stage renal failure, or on dialysis
  • History of myocardial infarction, stroke, transient ischemic attack, coronary artery intervention, CHF exacerbation, or any other major cardiac event requiring hospitalization within the last 6 months prior to screening or any cardiac history that would deem subject not eligible for anesthesia (unless documented clearance by cardiologist and/or treating endoscopy team)
  • History of new or worsening signs or symptoms of coronary heart disease (CHD) within the last 3 months
  • Known case of severe peripheral vascular disease, defined as AMA Criteria Class 1 or greater75 (Appendix 19.8)
  • Known case of symptomatic heart failure with reduced ejection fraction (NYHA Class II-IV) requiring pharmacologic therapy to control symptoms
  • Clinically significant electrocardiogram (ECG) findings such as new clinically significant arrhythmia, ST segment changes, or other conduction disturbances that increase risk of heart disease and require intervention as determined by the investigator
  • Subjects who are at risk of pancreatitis, particularly those with a recent fasting triglyceride value of >600 mg/dL within the past 3 months
  • Actively participating in a weight-loss program and currently not in the maintenance phase
  • General contraindications to deep or conscious sedation, general anesthesia, high risk as determined by anesthesiologist (e.g., ASA score 4 or higher), or contraindications to upper GI endoscopy
  • History of substance use disorder based on the DSM-5 criteria76 within the last 12 months (American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition).
  • Use of weight loss medication such as Meridia, Xenical, over-the-counter weight-loss medications, or other prescribed medications used specifically for the purpose of weight loss
  • Use of dietary supplements or herbal preparations that may have unknown effects on glycemic control or risk of bleeding
  • Participating in another ongoing clinical trial of an investigational drug or device
  • History of non-adherence to treatment in the previous 6 months, as determined by the investigator based on patient history, HbA1c value, or drug accountability
  • Any other mental or physical condition which, in the opinion of the investigator, makes the subject a poor candidate for clinical-trial participation. Physical conditions assessed via endoscopy prior to participant study enrollment at visit 4 include, but not limited to:
  • Active and uncontrolled gastroesophageal reflux disease (GERD) defined as Los Angeles Grade C or D esophagitis
  • Abnormalities of the GI tract preventing endoscopic access to the duodenum
  • Anatomic abnormalities in the duodenum that would preclude the completion of the DMR procedure, including tortuous anatomy
  • Malignancy newly diagnosed by endoscopy
  • Upper GI conditions (esophageal, gastric, or intestinal) such as clinically significant ulcers, polyps, varices, strictures, congenital or acquired intestinal telangiectasia, or other conditions listed under exclusion criteria
  • Unwilling or unable to comply with study visits and other study procedures as required per protocol
  • Recovered from severe COVID-19 infection (requiring hospitalization) but with persistent long COVID-19 symptoms (i.e., the individual has not recovered for several weeks or months since the start of symptoms that were suggestive of COVID-19, irrespective if the individual was tested or not)

Trial locations and contacts

58 sites in 7 countries.

58 sites in 7 countries

United States51 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • AHN - Avon

    Avon, Indiana, 46123

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Investigators Research Group

    Brownsburg, Indiana, 46112

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Northwestern Unviersity

    Evanston, Illinois, 60611

  • Northeast Research Institute, Llc

    Fleming Island, Florida, 32003

  • AHN- Franklin

    Franklin, Indiana, 46131

  • AHN - Greenfield

    Greenfield, Indiana, 46140

  • Baylor St. Luke's Medical Center

    Houston, Texas, 77030

  • Biopharma Informatic, Llc

    Houston, Texas, 77089

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Jefferson City Medical Group

    Jefferson City, Missouri, 65109

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Endocrine Associates of West Village

    Long Island City, New York, 77089

  • Angel City Research , Inc.

    Los Angeles, California, 90010

  • UCLA Health

    Los Angeles, California, 90095

  • University of Louisville

    Louisville, Kentucky, 40202

  • Alcanza Clinical Research, LLC

    Methuen, Massachusetts, 01844

  • University of Miami

    Miami, Florida, 33136

  • West Virginia University

    Morgantown, West Virginia, 26506

  • AHN - Muncie

    Muncie, Indiana, 47304

  • Tulane University

    New Orleans, Louisiana, 70112

  • NYU Langone Gastroenterology Associates

    New York, New York, 10016

  • Synexus Clinical Research, New York

    New York, New York, 10017

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Weill Cornell Medicine

    New York, New York, 10065

  • Care Access Santa Clarita

    Newhall, California, 91321

  • Hoag Hospital

    Newport Beach, California, 92663

  • West Orange Endocrinology

    Ocoee, Florida, 34761

  • Advent Health Orlando

    Orlando, Florida, 32804

  • Synexus Research

    Orlando, Florida, 32806

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Helios CR, Inc

    Phoenix, Arizona, 85028

  • Preferred PCP - Pittsburgh

    Pittsburgh, Pennsylvania, 15201

  • Preferred Primary Care Physicians

    Pittsburgh, Pennsylvania, 15236

  • M3 Wake Research

    Raleigh, North Carolina, 27612

  • Stanford University Medical Center

    Redwood City, California, 94063

  • AcellaCare Salisbury

    Salisbury, North Carolina, 28144

  • Mills Peninsula Health Center

    San Mateo, California, 94401

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98104

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • IMA Clinical Research St. Louis

    St Louis, Missouri, 63117

  • AcellaCare Piedmont

    Statesville, North Carolina, 28625

  • Simcare Medical Research, Llc.

    Sugar Land, Texas, 77478

  • Care Access Warwick

    Warwick, Rhode Island, 02886-4463

  • AcellaCare Wilmington

    Wilmington, North Carolina, 28401

Other trials in United States

United Kingdom2 sites

  • Cleveland Clinic London

    London, England, SW1X &AW

  • King's College Hospital

    London

Other trials in United Kingdom

Belgium1 site

  • Cliniques Universitaires de Bruxelles Hopital Erasme

    Brussels

Other trials in Belgium

Ireland1 site

  • University College Dublin

    Dublin

Other trials in Ireland

Italy1 site

  • Italy Gemelli

    Roma

Other trials in Italy

Netherlands1 site

  • Universiteit Van Amsterdam Academisch Medisch Centrum

    Amsterdam

Other trials in Netherlands

Switzerland1 site

  • University Hospital Zurich

    Zurich, CH-8091

Other trials in Switzerland

About this study

Official title: A Prospective, Randomized, Double-Blind, Sham-Controlled, Multi-Center, Pivotal Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes With Inadequate Glycemic Control

The Revita® system is being investigated to assess the efficacy of DMR versus Sham on improvement in Glycemic, Hepatic and Cardiovascular endpoints for patients with Type 2 Diabetes who are inadequately controlled on one or more glucose lowering agents. The purpose of this study is to demonstrate the efficacy and safety of the Fractyl DMR Procedure using the Revita® System compared to a sham. Subjects randomized to the DMR procedure will be followed per protocol till 48 weeks post treatment. Subjects in the Sham treatment arm will be offered cross over to receive the DMR treatment at 48 weeks and will be followed per protocol for 48 weeks post treatment.

Conditions
Type 2 Diabetes
Being tested
Duodenal Mucosal Resurfacing (DMR), Duodenal Mucosal Resurfacing (Sham)
Keywords
Type 2 Diabetes, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Revita System, Duodenal Mucosal Resurfacing, Insulin-Dependent Diabetes Mellitus
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Diabetes Mellitus, Type 1

What participants receive

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

  • Duodenal Mucosal Resurfacing (DMR)Device

    The Fractyl DMR Procedure utilizes the Revita® Catheter to perform hydrothermal ablation of the duodenum. The Catheter is delivered trans-orally over a guide-wire to first inject saline to lift the sub-mucosal space, followed by an ablation of the duodenal mucosa. Subjects who receive the DMR treatment are followed for 48 weeks post treatment.

  • Duodenal Mucosal Resurfacing (Sham)Device

    The Sham procedure consists of placing the Revita® Catheter as described above into the duodenum for a minimum of 30 minutes and then removing it from the patient. Subjects who receive the Sham procedure are followed for 48 weeks post treatment and are offered cross over to undergo the DMR procedure at 48 weeks and are followed for further 48 weeks post treatment. Sham subjects who choose not to cross over are discontinued from the study.

Study groups in NCT04419779
Study groupRoleWhat they receive
Duodenal Mucosal Resurfacing (DMR)Active comparatorDuodenal Mucosal Resurfacing (DMR) treatment will include hydrothermal ablation of the duodenal muscosa in an upper endoscopic procedure in patients with inadequately controlled type 2 diabetes.
Receives: Device: Duodenal Mucosal Resurfacing (DMR)
Duodenal Mucosal Resurfacing Sham (Sham)Sham comparatorDuodenal Mucosal Resurfacing Sham (Sham) treatment will include an upper endoscopic procedure similar to DMR treatment without hydrothermal ablation of the duodenal mucosa in patients with inadequately controlled type 2 diabetes.
Receives: Device: Duodenal Mucosal Resurfacing (Sham)

What is being measured

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

  1. Demonstrate superiority of Revita DMR to sham in improving glycemic control

    Change from baseline in HbA1c at Week 24

    Measured: Baseline to Week 24

Secondary outcomes (4)

  1. Demonstrate superiority of Revita DMR to sham in achieving target HbA1c at 24 weeks

    The proportion of subjects who achieve an HbA1c of ≤7.0% at Week 24

    Measured: Baseline to Week 24

  2. Demonstrate superiority of Revita DMR to sham in fasting glucose at 24 weeks

    Change from baseline in fasting plasma glucose (FPG) at Week 24

    Measured: Baseline to Week 24

  3. Demonstrate superiority of Revita DMR to sham in weight loss at 24 weeks

    Percentage of total body weight loss (%TBWL) from baseline at Week 24

    Measured: Baseline to Week 24

  4. To demonstrate superiority of Revita DMR to sham in elimination of insulin use at 24 weeks in those subjects on insulin at baseline

    1. The proportion of subjects who discontinued insulin at Week 24 in those subjects on insulin at baseline

    Measured: Baseline to Week 24

Timeline

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

  1. First posted5 Jun 2020
  2. Study start8 Mar 2021
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2026 (estimated)

Why it stopped: Enrollment pause

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04419779
Sponsor's protocol ID
C-00044
Acronym
REVITALIZE 1
Status last verified
Nov 2025
First submitted
3 Jun 2020
Last updated
13 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Duodenal Mucosal Resurfacing (DMR) in people with Type 2 Diabetes, run by Fractyl Health Inc. at 58 sites in 7 countries.

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 17 inclusion and 52 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: paused, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, United Kingdom, Belgium, Ireland, Italy and 2 more countries. 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?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demonstrate superiority of Revita DMR to sham in improving glycemic control (time frame: Baseline to Week 24). 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 NCT04419779.

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 Nov 2025.

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