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

Paused · Not applicable · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT04419779

Run by

Fractyl Health Inc.

People needed

320

Starts

2021-03-08

Expected to finish

2026-01-01

Last updated by the study team

2025-11-13

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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,
• 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

You may not qualify if…

• 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.
• 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)

Where it is running

• HonorHealth Research Institute — Scottsdale, Arizona, United States
• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• Angel City Research , Inc. — Los Angeles, California, United States
• UCLA Health — Los Angeles, California, United States
• Care Access Santa Clarita — Newhall, California, United States
• Hoag Hospital — Newport Beach, California, United States
• Stanford University Medical Center — Redwood City, California, United States
• Mills Peninsula Health Center — San Mateo, California, United States
• Northeast Research Institute, Llc — Fleming Island, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• West Orange Endocrinology — Ocoee, Florida, United States
• Advent Health Orlando — Orlando, Florida, United States
• Synexus Research — Orlando, Florida, United States
• Northwestern Unviersity — Evanston, Illinois, United States
• AHN - Avon — Avon, Indiana, United States
• Investigators Research Group — Brownsburg, Indiana, United States
• AHN- Franklin — Franklin, Indiana, United States
• AHN - Greenfield — Greenfield, Indiana, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• AHN - Muncie — Muncie, Indiana, United States
• University of Louisville — Louisville, Kentucky, United States
• Tulane University — New Orleans, Louisiana, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Helios CR, Inc — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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