Health Condition 1: K77- Liver disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: Tab.Resemetirom 80 mg: Drug Name: Resmetirom
Dose: 80 mg orally
Frequency: Once daily
Duration: 180 days
Route: Oral administration
Purpose: To reduce liver fat improve liver stiffness
Sponsors
Mothishwaran
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male and female participants aged between more than 18 and less than or equal to 60 years. 2. Participants who are diagnosed with Metabolic dysfunction-associated steatotic liver disease (MASLD) defined as hepatic steatosis in adults (detected either by imaging techniques by biopsy) in addition to one of the following criteria s namely A. BMI more than or equal to 25 kg per m2 [23 kg per m2 in Asians] OR Waist circumference (WC) more than 94 cm (Male) 80 cm (Female) OR ethnicity adjusted. B. Fasting serum glucose more than 5.6 mmol per Litre [100 mg per dL] OR 2-hour post load glucose levels more than or equal to 7.8 mmol per Litre[more than or equal to 140 mg per dL] OR HbA1c more than or equal to 5.7% [39 mmol per Litre) OR type 2 diabetes OR treatment for type 2 diabetes. C. Blood pressure more than or equal to sysBP130 DysBP 85 mmHg OR specific antihypertensive drug treatment. D. Plasma triglycerides more than or equal to more than or equal to 1.70 mmol per L [150 mg per dL] OR lipid lowering treatment. E. Plasma HDL-cholesterol less than or equal to 1.0 mmol per Litre [40 mg per Deci Litre] (M) and more than or equal to 1.3 mmol per Litre [50 mg per dL] (F) OR lipid lowering treatment. 3. Non-invasive FIBROSCAN confirmed hepatic steatosis and stiffness as defined below, A. Liver Stiffness Measurement (LSM) score of more than or equal to 8 to less than or equal to 12 Kpa as per Vibration Controlled Transient Elastography (VCTE). B. Any grade of steatosis (S1-S3) as determined by Continuous Attenuation Parameter (CAP). (S1-mild: more than or equal 248 dB per m, S2-moderate:more than or equal 268 dB per m, S3- severe: more than or equal 280 dB per m). 4. Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Note: A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation or remaining celibate by choice) who meets the following criteria: a. Has not undergone a hysterectomy or bilateral oophorectomy; or b. Has not attained menopause (Women not menstruating for at least 12 consecutive months). 5. Male participants who are willing to refrain from donating sperm from first admission to the study until 90 days after the study completion.
Exclusion criteria
Exclusion criteria: 1. FibroScan LSM more than to 12.5 kPa biopsy-proven advanced fibrosis, or cirrhosis or related complications. Co-existing chronic liver diseases (e.g., viral hepatitis, autoimmune, DILI, hemochromatosis). Uncontrolled serious illnesses (e.g., severe anemia, CVD, psychiatric, malignancy), PT-INR more than 1.2. Muscle Disorders or Myopathies Bariatric surgery within 1 year, or prior participation in similar studies within 3 months. 6. Any concomitant serious disorders like chronic kidney disease, cardiovascular diseases, pulmonary disease, and use of chemotherapy agents or history of cancer. 7. Gravid women and lactating mother. 8. Heavy smoker, Chronic alcoholic, or drug abuse subjects 9. Known cases of malignancy, HIV infection, AIDS, etc. 10. Participants are not willing to sign the ICF and to attend the treatment schedule regularly.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Liver Stiffness Measurement LSM score measured by FibroScan Change in Controlled Attenuation Parameter CAP score measured by FibroScan Timepoint: Measured at Baseline and week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in body mass index Change in waist circumference Change in HDL cholesterol Change in triglyceride levels Change in HbA1C levels Change in fasting blood glucose levels Change in systolic blood pressure Change in diastolic blood pressure Change in AST levels Change in ALT levels Change in ALP levels Change in total bilirubin levels Change in quality of life score Number of adverse events during study periodTimepoint: Baseline Day 1 Day 30 plus or minus 3 days Day 60 plus or minus 3 days telephonic Day 90 plus or minus 3 days Day 135 plus or minus 3 days telephonic Day 180 plus or minus 3 days end of study | — |
Countries
India
Contacts
Public ContactMothishwaran
SRM College of Pharmacy
Outcome results
None listed