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

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and LXRg-SREBP-1c pathway in liver.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PharmaKing
• Treatments: Oltipraz

Criteria

Inclusion Criteria:

• A person the ages of 19 and 75 years old

• Patients with non-alcoholic fatty liver disease other than cirrhosis that meets all of the following criteria:

1. Abdominal ultrasonography of Screening indicates that the liver is brighter than the spleen or kidneys, causing suspected fatty liver

2. Persons with liver fat content is 20% or more on the MRS

3. Those who do not have significant alcohol intake within two years before screening (men: no more than 210 g per week; women: no more than 140 g per week)

4. Those who with an alcohol use disorder identification test (AUDIT) result point is no more than 7, during screening.

• Persons with body mass index (BMI) more than 23 kg/m2 during screening

• A person who satisfies the following laboratory test results when screening

1. Platelet ≥ 130,000/㎣

2. White blood cell (WBC) ≥ 3,000/㎣

3. Absolute neutrophil count (ANC) ≥ 1,500/㎣

4. Albumin ≥ 3.5 g/dL

5. Serum creatinine ≤ 1.5 X upper limit of normal (ULN)

6. ULN < Alanine transaminase (ALT) or aspartate transaminase (AST) ≤ 250 IU/L

• A person who is willing to maintain the same lifestyle (exercise, alcohol intake, diet, etc.) maintained for at least four weeks before screening during the clinical trial period.

• A person who voluntarily agrees to participate in this clinical trial

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