Health Condition 1: K740- Hepatic fibrosis
Conditions
Interventions
Intervention1: Resmetirom Tablet: Resmetirom Tablets 60 mg, 80 mg or 100 mg, Once Daily for 52 Weeks
Control Intervention1: Placebo of Resmetirom Tablets: Placebo of Resmetirom Tablets 60 mg, 80 mg, 1
Sponsors
Sun Pharma Laboratories Limited (SPLL)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender with age between 18 to 65 years (both inclusive) and willing to provide written informed consent. 2. Who do not have any history of significant alcohol consumption 3. Have at least 3 metabolic risk factors 4. Biopsy-proven Diagnosis of NASH based on a liver biopsy with fibrosis stage 2, or 3 on liver biopsy and NAS of greater than or equal to 4 5. Women of childbearing potential must have a negative urine pregnancy test at Screening and Randomization and agree to use highly effective methods of contraception to prevent pregnancy from study entry till end of study 6. Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners should be practicing highly effective contraception throughout the study period.
Exclusion criteria
Exclusion criteria: 1) History of significant alcohol consumption 2) Regular use of drugs historically associated with NAFLD 3) Thyroid diseases 4) History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study. 5) Weight gain or loss of greater than or equal to 5% total body weight within 12 weeks prior to randomization. 6) Type 2 diabetes patients with HbA1c greater than or equal to 9.0%. 7) Glucagon-like peptide 1 [GLP-1] agonist therapy. 8) Use of high dose vitamin E 9) Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis. 10) Diagnosis of hepatocellular carcinoma (HCC). 11) Hepatic decompensation 12) Patients with other chronic liver diseases 13) Patients having an active autoimmune disease, 14) Inability to safely obtain a liver biopsy. 15) Hypersensitivity to Resmetirom or to any of the excipients in study medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving NASH resolution with no worsening of fibrosis Timepoint: [Timeframe: Week 52] week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Proportion of MRI-PDFF Responders (patients achieving greater than or equal to 30% relative reduction in hepatic fat content) Timepoint: [Timeframe: Week 24, 52];Additional NAS and Fibrosis endpoints on Liver biopsyTimepoint: ;Change from baseline in Serum ALT, AST, GGT and ALPTimepoint: [Timeframe: Baseline, Weeks 24,52];Change from baseline in Serum total cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL cholesterol and triglyceridesTimepoint: [Timeframe: Baseline, Weeks 24, 52];Change from baseline in FibroScan LSM scoreTimepoint: [Timeframe: Baseline, Weeks 24 and 52];Change from baseline in FibroScan CAP scoreTimepoint: [Timeframe: Baseline, Weeks 24 and 52];Proportion of patients with a greater than or equal to30% reduction in FibroScan LSM scoreTimepoint: [Timeframe: Weeks 24 and 52];Change from baseline in SF-36 scoreTimepoint: [Timeframe: Baseline, Weeks 24 and 52];Safety: Number and proportion of patients with treatment emergent adverse events (TEAEs) and Serious Adverse Events (SAEs) Timepoint: [Timeframe: Throughout study duration] | — |
Countries
India
Contacts
Public ContactDr Rajiv Yadav
Sun Pharma Laboratories Limited
Outcome results
None listed