Health Condition 1: K758- Other specified inflammatory liverdiseases
Conditions
Interventions
Intervention1: Resmetirom 60 mg Tablet
: One tablet to be taken once daily with or without food, preferably at the same time for 52 weeks (364 Days).
Intervention2: Resmetirom 80 mg Tablet: One tablet
Sponsors
Ravenbhel Biotech
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female participants greater than or equal to 18 years to less than or equal to 65 years. 2. Confirmed diagnosis of NASH fibrosis in participants who meet one of the following criteria that is consistent with NASH liver fibrosis: Historical biochemical test for fibrosis: N-terminal pro-peptide of type III collagen (PRO-C3) greater than 14 ng/mL or Enhanced liver fibrosis (ELF) greater than or equal to 9 or Fibroscan with transient elastography greater than or equal to 8.5 kPa and controlled attenuation parameter grater than or equal to 280 dB.m-1. 3. Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) greater than or equal to 8% obtained during the screening period. 4. Biopsy-proven NASH (baseline liver biopsy), based on a liver biopsy obtained within 3 months of randomization with fibrosis stage, F2 or F3 on liver biopsy and NAS of greater than or equal to 4 with a score of at least 1 in each of the following NAS components: -Steatosis (scored 0 to 3) -Ballooning degeneration (scored 0 to 2) -Lobular inflammation (scored 0 to 3) 5. Participants who are willing to give informed consent for participation in the study and willing to adhere to all protocol procedures. Cohort specific Inclusion Criteria: Cohort I: Participants with a body weight of less than 60 kg. Cohort II: Participants with a body weight between 60 to less than 100 kg. Cohort III: Participants with a body weight of greater than or equal to 100 kg.
Exclusion criteria
Exclusion criteria: 1.Participants with a history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening. 2. Participants with regular use of drugs historically associated with NAFLD. 3. Participants with presence of cirrhosis on liver biopsy defined as stage 4 fibrosis (F4). 4. Participants with diagnosis of hepatocellular carcinoma (HCC). 5. Participants with hepatic decompensation. 6. Participants with chronic liver diseases other than NASH. 7. Participants whose Serum ALT greater than 250 U/L. 8. Participants with a diagnosis of type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) greater than or equal to 11.0%. 9. Participants with Estimated glomerular filtration rate (eGFR)less than 60 mL/min/1.73 m2 [using the Modification of Diet in Renal Disease (MDRD) equation] at screening. 10. Participants with Thyroid diseases: - Active hyperthyroidism. - Untreated clinical hypothyroidism defined by thyroid stimulating hormone (TSH) greater than 7 IU/L with symptoms of hypothyroidism or greater than 10 IU/L without symptoms. - Participants who have had a thyroidectomy and are on replacement thyroxine doses greater than 75 g per day are allowed. 11. Participants with known history of HIV, Hepatitis B and Hepatitis C. 12. Participants with history of any active autoimmune disease. 13. Participants with significant cardiovascular history defined as: myocardial infarction, unstable angina pectoris, transient ischemic attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or revascularization (coronary angioplasty or bypass grafts), or cerebrovascular accident. 14. Participants with clinically relevant current or past history of severe, unstable, or uncontrolled pulmonary, hepatic and renal diseases. 15. Participants with history of bariatric surgery or intestinal bypass surgery within the 5 years prior to screening or planned during the conduct of the study. 16. Currently taking prohibited concomitant medications listed and inability/unwillingness to discontinue them for the entire study period. 17. Participants with active, serious medical disease with a likely life expectancy less than 2 years. 18. Any other health or mental condition or any significant laboratory parameters that in the investigators opinion may adversely affect the participants ability to complete the study or its measures or that may pose significant risk to the participant. 19. Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent. 20. Female participants who are pregnant or lactating or planning to become pregnant during the study period. Females or males who are not ready to use acceptable contraceptive methods during the course of study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion with resolution of NASH (ballooning 0, inflammation 0,1) associated with at least 2-point reduction in NAFLD Activity Score (NAS) without worsening of fibrosis stage from baseline to end of study visit (Week 52). Proportion with at least a 1-point improvement in fibrosis stage with no worsening of NAS from baseline to end of study visit (Week 52).Timepoint: 52 Weeks (364 Days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change in the low-density lipoprotein from baseline to end of study visit (Week 52). Timepoint: 52 Weeks (364 Days);Safety Parameter: The assessment of safety will be based on the frequency of Adverse Events and Changes in laboratory parameters.Timepoint: 52 Weeks (364 Days) | — |
Countries
India
Contacts
Public ContactDr Neeta Nargundkar
Biosphere Clinical Research Pvt Ltd
Outcome results
None listed