A Study of Resmetirom Tablets in People with NASH and Moderate to Severe Liver Scarring

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Resmetirom tablets 60 80 100 mg: Once daily orally can be taken with or without food for 52 weeks Control Intervention1: Matching Placebo: Once daily, orally can be taken with or without food for 52 weeks. CONDITION: Health Condition 1: K768‐ Other specified diseases of liver PRIMARY OUTCOME: Mean percentage change in liver fat content as measured by non invasive Magnetic Resonance Imaging Proton Density Fat Fraction MRI PDFF from baseline to week 24Timepoint: from baseline to week 24 SECONDARY OUTCOME: Mean percentage change in liver fat content as measured by MRI PDFF ; Proportion of participants with at least a 1 point improvement in fibrosis stage with no worsening of steatohepatitis as assessed by liver biopsy as agreed by participant ; Mean absolute change in liver fat as measured by MRI PDFF ; Mean change in liver stiffness kPa & controlled attenuation parameter CAP as measured by Fibro scan ; Mean change in alanine transaminase aspartate transaminase alkaline phosphatase gamma glutamyl transpeptidase MELD score & total bilirubin ; Mean change in Body weight body mass inde XHbA1c & fasting blood glucose ; Mean change in lipid profile total cholesterol low density lipoprotein cholesterol high density lipoproteins cholesterol triglycerides ; Mean changes in thyroid function tests ; Mean change from baseline on N terminal type 3 collagen pro peptide PRO C3 & enhanced liver function ELF testTimepoint: baseline to 52 ; at week 52 ; baseline to weeks 12 24 & 52 ; baseline to weeks 12 24 & 52 ; baseline to weeks 4 12 24 & 52 ; baseline to weeks 4 12 24 & 52 ; baseline to weeks 12 24 & week 52 ; baseline to weeks 12 24 & week 52 ; to weeks 24 & 52 ; at week 52 ; INCLUSION CRITERIA: Have a biopsyconfirmed diagnosis of NASH with fibrosis stage F2 or F3 and a NASH activity score NAS grater than or equal to 4 with at least 1 point in inflammation and ballooning Meet at least one of these indicators of NASH‐related fibrosis Metabolic risk factors at least 3 of 5 obesity abnormal blood lipids high blood pressure type 2 diabetes or elevated liver enzymes Biochemical test PROC3 grater than 14 ng per mL or ELF Grater than equal to 9. FibroScan liver stiffness between 8.5 to 14 kPa and fat content CAP Grater than equal 280 dB per m. Have MRI PDFF liver fat fraction Grater than equal 8 percentage at screeningKidney function GFR Grater than equal 45 ml per min per 1.73m square On stable treatment for diabetes blood pressure or cholesterol if applicable Willing to keep consistent lifestyle habits during study Women of childbearing potential Must have a negative pregna
Epistemonikos ID: 0e811123d3dc82c9209c77b35d5966f1c74483ce
First added on: Oct 08, 2026