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

Exclusion Criteria

• •1. 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.
• •2. Use of any of the following medications:
• •1. Metformin
• •2. Combination drugs that include Metformin
• •3. Sildenafil
• •4. Tadalafil
• •5. Vardenafil
• •6. Pioglitazone
• •7. Rosiglitazone
• •8. Short acting insulins
• •9. An alpha blocker
• •10. Oral nitrates
• •11. Medications associated with increased hepatic steatosis
• •12. Insulins
• •13. 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
• •14. Any dietary supplement other than multi-vitamins
• •3. Evidence of significant alcohol consumption (defined as \>7 drinks/week for females and \>14 drinks/week for males) within 6 months prior to randomization or presence or suspicion of other forms of chronic liver disease (e.g., cirrhosis, autoimmune hepatitis (\>1:160 ANA), Wilson's disease, Hemochromatosis (Ferritin \>1000 ug/L and percent iron saturation \>45%), hepatitis A, B or C)
• •4. Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions:
• •1. Unable to undergo MRI or contraindications for MRI procedure
• •2. History of cardio- or cerebro-vascular disease event within the previous 6 months
• •3. Requires anti-coagulation therapy
• •4. Gastrointestinal disorders including, but not limited to, the following: pancreatitis, inflammatory bowel disease, or other diseases associated with malabsorption or persistent abdominal discomfort
• •5. Endocrine disorders other than type 2 diabetes and hypothyroidism on stable replacement therapy
• •6. Chronic infection (e.g., tuberculosis, human immunodeficiency virus infection, hepatitis A virus, hepatitis B virus, or hepatitis C virus)
• •7. Neurological or psychiatric diseases that preclude valid execution of informed consent or may interfere with the subject's compliance with study procedures (e.g., major depressive disorder within the last 2 years, a history of suicidal behavior in the last 3 months)
• •8. History of other psychiatric disorders including schizophrenia and bipolar disorder)
• •5. Participation in a weight loss program within the past 3 months.
• •6. Weight change ≥5% during the past month.
• •7. History of substance abuse (including alcohol abuse as defined above) in the past 3 months or a positive screen for drugs of abuse or alcohol at screening.
• •8. Has received any investigational drug within 3 months of Screening.
• •9. Has donated blood within 3 months before Screening or is planning to donate blood during the study.
• •10. Has had a serious infection, such as pneumonia in the previous 12 weeks
• •11. Has known allergies or hypersensitivity to metformin, sildenafil or leucine
• •12. Is an immediate family member (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the clinical study site, or NuSirt Biopharma.
• •13. Is employed by NuSirt Biopharma (defined as an employee, temporary contract worker, or designee responsible for the conduct of the study).
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