[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

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Study’s contact

Call center

781-902-8840

Email address

shackett@fractyl.com

Condition

NAFLD,NASH - Nonalcoholic Steatohepatitis,Type 2 Diabetes

Treatment type

Interventional

Investigational product

Duodenal Mucosal Resurfacing (DMR)

Phase

N/A

Sponsor

Fractyl Laboratories, Inc.

ClinicalTrials.gov identifier

NCT04419779

Study number

C-00044

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About the study

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 with insulin therapy. 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 24 weeks post treatment.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. inclusive) 3. Subjects with type 2 diabetes on stable doses of metformin (maximum tolerated
  2. dose) requiring a minimum of 20 units up to a maximum of 60 units of basal insulin; OR Subjects currently on basal insulin (20-60 units/
  3. day) who meet other inclusion criteria but are on other ADAs (including GLP-1a, DPP4,
  4. etc) are eligible following an 8-week washout period and initiating on Metformin if not already on it. 4. Glycosylated Hemoglobin A1C (
  5. HbA1C) of 7.5-9.5% (both
  6. inclusive) confirmed at the end of run in period. 5. FPG ≥180 to <270 mg/dl (measured at least 24 hours after the last dose of glargine or at least 12 hours after the last dose of NPH
  7. insulin) 6. Body Mass Index (
  8. BMI) ≥ 28 and ≤ 40 kg/m2 7. Women of Child-bearing potential (
  9. WOCBP) should have negative urine beta hCG pregnancy test and must agree to use two of the established contraceptive methods throughout the study duration 8. Able to sign an informed consent form and comply with study requirements.
Exclusion criteria
  1. longer) before the screening 8. Diagnosed with Type 1 Diabetes or with a recent history of ketoacidosis 9. Ketosis-prone Type 2 Diabetes 10. History of non healing diabetic ulcers or amputations 11. History of more than 1 severe hypoglycemia episode or unawareness within past 6 months of screening 12. Known intestinal autoimmune disease, as evidenced by a positive Anti-GAD test, including Celiac disease, or pre-existing symptoms of lupus erythematosus, scleroderma or other autoimmune connective tissue disorder, which affects the small intestine 13. Secondary hypothyroidism or inadequately controlled primary hypothyroidism (TSH value outside the normal range at
  2. screening) 14. Known history of thyroid cancer or hyperthyroidism who have undergone treatment within past 12 months or inadequately controlled hyperthyroidism 15. An uncontrolled endocrine condition such as multiple endocrine neoplasia etc (except type 2
  3. diabetes) 16. Known history of a structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug-refractory esophageal reflux symptoms, active and uncontrolled GERD (grade 3 esophagitis or
  4. greater) 17. Known history of a structural or functional disorder of the stomach, including gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (> 2 cm), cancer or any other disorder of the stomach 18. 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 19. Known history of chronic pancreatitis or a recent history of acute pancreatitis within the past year 20. History Hepatitis B, C or other clinically active acute liver diseases 21. Symptomatic gallstones or symptomatic kidney stones, acute cholecystitis 22. Clinically active systemic infection 23. Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy or radiotherapy within the past 12 months, who have clinically-significant leukopenia, who are positive for the human immunodeficiency virus (
  5. HIV) or whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the Investigator 24. History of malignancy within the past 5 years 25. Known active coagulopathy, or current upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, or congenital or acquired intestinal telangiectasia 26. Subjects with active helicobacter pylori infection (Subjects may be enrolled if they had history of h pylori infection and were successfully
  6. treated) 27. Known cases of anemia, thalassemia or conditions that affect RBC turnover such as recent blood transfusion within 90 days 28. Use of anticoagulation therapy (such as
  7. warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure 29. Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled
  8. forms) for more than 10 consecutive days within 90 days prior to the Screening Visit. 30. Use of drugs known to affect GI motility (e.g.
  9. Metoclopramide) 31. History of moderate to severe chronic kidney disease (CKD), with estimated glomerular filtration rate (
  10. eGFR) <45 ml/min/1.73m2 (estimated by Modification of Diet in Renal Disease [MDRD]) or end stage renal failure or on dialysis 32. History of Myocardial Infarction, Stroke, or major event requiring hospitalization within the last 3 months prior to screening 33. History of new or worsening signs or symptoms of CHD within the last 3 months 34. Known case of severe peripheral vascular disease 35. Known case of heart failure requiring pharmacologic therapy 36. Clinically significant ECG findings such as new clinically significant arrythmia or conduction disturbances that increases risk and requires intervention as determined by the investigator 37. Fasting triglyceride value of >600 mg/dL (increases risk of
  11. pancreatitis) 38. Participating in a weight loss program and is currently not in the maintenance phase 39. General contraindications to deep sedation or general anesthesia (e.g. ASA score 3 or
  12. 4) or upper GI Endoscopy 40. History of any illicit alcohol or substance abuse 41. Use of weight loss medication such as Meridia, Xenical, or over the counterweight loss medications. 42. Use of Dietary supplements or herbal preparations that may have unknown effects on glycemic control, risk of bleeding 43. Participating in another ongoing clinical trial of an investigational drug or device 44. History of non-adherence to treatment in the previous 6 months, as determined by the investigator based on patient history, HbA1C value and/or drug accountability. 45. Any other mental or physical condition which, in the opinion of the investigator, makes the subject a poor candidate for clinical trial participation 46. Unwilling or unable to perform self-monitoring of blood glucose (SMBG), complete the patient diary, or comply with study visits and other study procedures as required per protocol.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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