The Effect Of NS-0200 Versus Placebo On Hepatic Fat Content In Patients With Non Alcoholic Fatty Liver Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: NAFLD

In brief

The goal of this study is to determine if NS-0200 can reduce the amount of liver fat in patients diagnosed with non-alcoholic fatty liver disease (NAFLD). This study will compare two doses of NS-0200 to placebo in NAFLD patients.

Key facts

Study ID

NCT02546609

Run by

NuSirt Biopharma

People needed

91

Starts

2015-11-19

Expected to finish

2017-01-31

Last updated by the study team

2018-05-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-75 at study entry.
• Is male, or female and, if female, meets all of the following criteria:
• Not breastfeeding
• Post-menopausal or negative serum pregnancy test result (human chorionic gonadotropin, beta subunit [β-hCG]) at Screening /Visit 1 (Day-14/Week-2) (not required for hysterectomized females)
• If of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as double barrier methods [male condom with spermicide, with or without cervical cap or diaphragm], implants, injectables, oral contraceptives [must have been using for at least the last 3 months], some intrauterine contraceptive devices, tubal ligation, or in an established relationship with a vasectomized partner) during the entire duration of the study.
• Has been diagnosed with NAFLD via CT (positive for excess liver fat), ultrasound (positive for excess liver fat), MRI (PDFF showing > 15% liver fat) or via biopsy (showing >33% fat) within the past six months. If diagnosis was between 3 and 6 months prior to Screening, an ultrasound (positive for excess liver fat) is required prior to the Screening /Visit 1 (Day-14/Week-2) MRI.
• Has liver fat (as measured by PDFF via MRI) greater than 15% at Screening/Visit 2 (Day-7/Week-1)
• Has had ALT levels >30 U/L for men, >19 U/L for women measured within 8 weeks of enrollment
• Has an HbA1c equal to or less than 9% at Screening /Visit 1 (Day-14/Week-2)
• Has a BMI between 25kg/m2 and 40 kg/m2
• Otherwise stable health for preceding twelve weeks
• Clinical laboratory tests (hematology, clinical chemistry, and urinalysis) either normal or with abnormalities consistent with NAFLD.
• Is able to read, understand, and sign the informed consent forms (ICF) and, when applicable, an authorization to use and disclose protected health information form (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA] legislation), communicate with the investigator, and understand and comply with protocol requirements.

You may not qualify if…

• Clinically significant renal dysfunction defined as a serum creatinine concentration >1.4 mg/dL (females) or >1.6 mg/dL (males) or a blood urea nitrogen concentration >45 mg/dL at screening.
• Use of any of the following medications:
• Metformin
• Combination drugs that include Metformin
• Sildenafil
• Tadalafil
• Vardenafil
• Pioglitazone
• Rosiglitazone
• Short acting insulins
• An alpha blocker
• Oral nitrates
• Medications associated with increased hepatic steatosis
• Insulins
• OCT2/MATE inhibitors (e.g. cimetidine, quinidine, and pyrimethamine)
• Methotrexate
• Tamoxifen
• Corticosteroids (Nasal steroids are allowed if the subject has been on a stable dose for the past 12 weeks and the dose employed does not exceed the maximal recommended dose.)
• Estrogens
• Amiodarone
• Valproic acid
• Coumadin
• Isoniazide
• Nucleoside analogues used for the treatment of HIV infections
• Any dietary supplement other than multi-vitamins

Where it is running

• Catalina Research Institute — Chino, California, United States
• University of California San Diego — San Diego, California, United States
• Rocky Mountain Research — Wheat Ridge, Colorado, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• GI Specialists of Georgia — Marietta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States
• Sterling Research — Cincinnati, Ohio, United States
• Premier Clinical Research — Clarksville, Tennessee, United States
• Gastro One — Germantown, Tennessee, United States
• Quality Medical Research — Nashville, Tennessee, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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