Oltipraz for Liver Fat Reduction in Patients With Non-alcoholic Fatty Liver Disease Except for Liver Cirrhosis

Exclusion Criteria

• •A person who has history of following disease or surgery
• •1. Malignant tumour with liver cancer
• •2. Malignant tumor excluding liver cancer, However, registration is possible in the following cases
• •1. If the investigator determines that the patient has been completely cured after maintaining the condition for at least five years
• •2. In case of basal cell or squamous cell carcinoma of the skin, the patient is able to maintain a complete condition for more than three years in the case of cainoma in the cervix (CIN) and carcinema in situ (CIS), and other areas.
• •3. autoimmune disease (e.g., inflammatory bowel disease, autoimmune hemolytic disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis, severe psoriasis, etc.)
• •4. Bariatric surgery within 24 weeks before screening
• •A Person who has comorbidity of the following diseases at the time of screening
• •1. Liver cirrhosis identified by an epidemiological or histological examination
• •2. Cumulative disease (e.g., alcohol liver disease, toxic hepatitis, autoimmune liver disease, metabolic liver disease, biliary closure, etc.) that may indicates liver abnormalities other than non-alcoholic fatty liver disease
• •3. A Person who has been infected or has Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).
• •4. Type 1 diabetes or type 2 diabetes (hemoglobin A1c (HbA1c) \> 9%)
• •5. A person who has positive result of Human immunodeficiency virus antibody (HIV Ab).
• •6. A persons with conditions that may affect the effectiveness and safety by investigator
• •A person with AST/ALT ratio of more than 2 at screening
• •The person who has the following medication history
• •1. Persons administered vitamin E (≥ 800 IU/day) or thiazolidatedione drugs or glucagon-like peptide-1 (GLP-1) agonist drugs within 12 weeks prior to screening
• •2. Persons who were given antiobestic drug within 12 weeks of screening For example; antiobestic drug with Central nervous system action: Amfepramone, bupropion and naltrexone, cathine, clobenzorex, dexfenfluramine, ephedrine combinations, etilamfetamine, fenfluramine, lorcaserin, mazindol, mefenorex, phentermine, sibutramine, Peripheral neurotic Obesity drugs: Orlistat, Rimonabant, etc
• •3. A person who received medications that could cause fatty liver disease within 8 weeks prior to screening For example; Administration of systemic glucocorticoids for more than two weeks Anabolic steroid-based drug, Estrogen-based drug, Azole-based antimicrobial agent, Nucleoside, Nucleotide reverse transcriptase inhibitor-based drug, Tetracycline-based drug, Amiodarone, tamoxifen, methotrexate, valproic acid, etc
• •4. A person who administered drugs that may affect the progress of non-alcoholic fatty liver disease within 4 weeks prior to screening or who require administration during clinical trials For example; Silymarin, biphenyl dimethyl dicarboxylate (DDB), ursodeoxycholic acid (UDCA), S-adenosyl-L-methionine (SAMe), betaine, pentoxyfylline, sodium-glucose cotransporter-2 (SGLT-2) inhibitor, omega 3 fatty acid, etc.
• •1. However, the following drugs can be registered if they are under stable dosage for at least 12 weeks and are expected to remain unchanged during clinical trials; Sulfonylurea-based drug, metformin, insulin, dipeptidyl peptidase-4 inhibitor (DPP-4 inhibitor), a-glucosidase inhibitor (a-GI), meglitinide-based drug, statin-based drug, fibrate-based drug, nicotinic acid, ezetimibe, beta-blockers based drug, thiazide based drug
• •A person who receive non-drug treatment that may affect the liver within 4 weeks prior to screening.
• •A person who administered/treated with other clinical trials/medical devices within 4 weeks prior to screening
• •Those who are not able to MRS(I)
• •A female who is pregnant, may be pregnant, or is lactating
• •A person who is not willing to use appropriate contraceptives during this clinical trial.
• •A person who is hypersensitive to the Investigational Product
• •A person who is deemed ineligible for clinical trials by the investigator