Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: AD 64: This is a 4-arm randomized, double-blind, placebo-controlled design, with patients receiving either AD64 500 mg, AD64 1000 mg or matching placebo twice daily of subjects to study
Sponsors
Bioplus Life Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 to 75 years 2. Diagnosis of MASH as per EASL guidelines 3. MRI PDFF fat fraction more than 8 percent obtained during the screening period (baseline MRI-PDFF) or a historic MRI PDFF less than or equal to 8 weeks old at the time of randomization. 4. Liver enzymes: Alanine transaminase and Aspartate transaminase levels less than or equal to 5 times upper limit of normal 5. Body mass index BMI 25 to 45 kg per meter square 6. Stable dyslipidemia therapy for more than 30 days prior to randomization. 7. Stable body weight: 5 percent for at least 3 months prior to screening
Exclusion criteria
Exclusion criteria: 1. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening 2. Regular use of drugs historically associated with NAFLD 3. History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study. 4. Weight gain or loss more than total body weight within 12 weeks prior to randomization 5. HbA1c more than 9.0percent 6. Presence or history of hepatic decompensation eg ascites, variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis) or liver transplantation; hepatocellular carcinoma; and gastro-esophageal varices within the past 360 days before screening. Model for End-stage Liver Disease score more than or equal to 12, as determined at Screening unless due to therapeutic anti coagulation or Gilbert syndrome 7. Chronic liver diseases 8. Has an active autoimmune disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving more than 30 percent relative reduction in hepatic fat on MRI PDFF at 12 and 36 weeksTimepoint: The proportion of patients achieving more than 30 percent relative reduction in hepatic fat on MRI PDFF at 12 and 36 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety & tolerability of the investigational medicinal productTimepoint: 52 weeks | — |
Countries
India
Contacts
Public ContactDr Shiran Shetty
KMC Manipal
Outcome results
None listed