Health Condition 1: K740- Hepatic fibrosis
Conditions
Interventions
Intervention1: Saroglitazar: Dose - 4 mg
Route - Per Oral
Frequency - once a day
Duration - 52 weeks
Control Intervention1: NIL: NIL
Sponsors
Principal Investigator
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of MASLD defined as per the recent multi-society Delphi consensus for new NAFLD nomenclature (2023) Advanced fibrosis â?? F3 (defined as LSM values from 9.7 to 13.5 kPa) Lipid profile range in the inclusion criteria â?? TG more than or equal to 150 mg per dl and LDL more than or equal to 100 mg per dl and HDL less than or equal to 40 mg per dl. Subjects who are willing and able to comply with treatment plan, laboratory tests. Subjects who are willing to provide a written informed consent
Exclusion criteria
Exclusion criteria: History of other chronic liver disease (HBV, HCV, autoimmune, cholestatic, significant alcohol) and hemochromatosis Cirrhosis ALT or AST more than 5 times ULN. Severe renal insufficiency (eGFR less than 30 mL per min per 1.73 m²) or requiring hemodialysis. Unstable cardiovascular disease or severe cardiopulmonary disease defined as NYHA class more than II, EF less than 40-45%, FEV1 by FVC less than 60% History of diabetes (HbA1c more than 6.5%). History of malignancy in past 5 years or active neoplasm. Illicit (non-alcoholic) substance use within the past 12 months. Use of other investigational agents for MASLD within prior 6 months. Pregnancy or planning conception or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hepatic fibrosis(LSM) measured by FibroscanTimepoint: Baseline, 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in hepatic steatosisTimepoint: Baseline, 52 weeks;Change in AST & ALT levelsTimepoint: Baseline, 24 weeks, 52 weeks;Changes in Serum bilirubin levelsTimepoint: Baseline, 24 weeks, 52 weeks;Changes in lipid profile levelsTimepoint: Baseline, 24 weeks, 52 weeks;Changes in fasting blood sugar & HbA1c levelsTimepoint: Baseline, 24 weeks, 52 weeks;Change in non-invasive scores like NAFLD fibrosis score, APRI & FIB-4 scoreTimepoint: Baseline, 24 weeks, 52 weeks;Incidence of adverse events/major adverse eventsTimepoint: 52 weeks | — |
Countries
India
Contacts
Public ContactIshan Garg
DMCH Ludhiana
Outcome results
None listed