Efficacy and Safety of Picroliv in Patients With Non-Alcoholic Fatty Liver Disease

Prior treatment

• Patients on drugs potentially associated with NAFLD such as amiodarone, methotrexate, perhexiline, estrogens, tamoxifen, nifedipine, diltiazem, chloroquine and other hepatotoxic agents as per the discretion of the study investigator.
• Subjects on anti TNF therapies, other biologicals and probiotics

Other illness

• Hepato-biliary disorders: Cirrhosis, biliary obstruction, chronic cholecystitis, cholelithiasis, active or chronic active Hepatitis B or hepatitis C, autoimmune liver diseases
• Medical conditions including stroke, Alzheimer's disease, tuberculosis, Ischemic Heart Disease (IHD), Deep Vein Thrombosis (DVT), pancreatitis, inflammatory rheumatic diseases, cancer or any disorder that may potentially impact the outcome measures
• Medications for disease conditions (e.g., HIV-1, HBV, or HCV infection, active cancer, transplantation are also excluded from the study.
• Any disorder or clinically significant finding that may potentially impact the outcome measures as per the discretion of the study investigator.
• Patients with a history of serious drug allergies (such as anaphylactic shock)

Lab values

• eGFR \< 60 mL/min / 1.73m2 or patients on dialysis
• Subjects on medications that may affect glucose metabolism such as corticosteroids, opiates, barbiturates and anticoagulants.

Other

• Significant alcohol consumption (\> 210 g/week in males and \> 70 g/week in females)
• Subjects on Thiazolidinediones (TZDs), Saroglitazar, Atazanavir, Indinavir, Ketoconazole, Valproic acid, Silybum marianum, Valeriana officinalis and hepatoprotective plants / Traditional medicine formulations / natural products.
• Pregnant and lactating women.
• Not willing to provide written informed consent
• Females unwilling to use any form of contraception during the trial.

• Age: 18- 60 years
• Sex: Both males and females
• Patients showing presence of hepatic fat fraction as defined by ≥ 10% on MRI-PDFF at screening.
• Liver enzymes normal or above the ULN (upper limit of normal range) but less than 3 times
• Hemoglobin ≥10 g/dL, a platelet count ≥ 100 x 109/L, and a white blood cell count ≥ 3.0 x 109/L
• HbA1c \< 7% (if participant has Type 2 diabetes mellitus (T2DM) should be controlled with appropriate treatment for the same except thiazolidinediones)
• TSH within normal limits (WNL) at screening
• If on metformin, sulfonylureas, statins, or fibrates, subjects must be on a stable dose of these drugs for at least three months prior to Screening and during the study will be allowed if on stable doses in the preceding 12 weeks and will be continued throughout the study.