MASH - Metabolic Dysfunction-Associated Steatohepatitis
Conditions
Keywords
Resmetirom, MASH, Safety, Efficacy
Brief summary
Phase 4 clinical trial study aims to further evaluate the safety and therapeutic efficacy of Resmetirom in Pakistani patients with fibroscan proven MASH.
Interventions
DRUGResmetirom
1st FDA approved MASH therapy
Sponsors
Nabiqasim Industries (Pvt) Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* • At least one metabolic comorbidity (e.g., T2DM, obesity, dyslipidemia and hypertension) * Clinical diagnosis of MASH using: * LSM ≥ 8.5kpa And/or * FAST score ≥0.67 And/or * FibroScan CAP ≥ 275 dB/m And/or * FIB-4 \> 1.3
Exclusion criteria
* • History of drug addiction and alcoholism * Cirrhosis or decompensated liver disease * Chronic viral hepatitis HBV, HCV) * MACE including MI, Stroke, PE etc. * Pregnant/lactating women * Concurrent use of other investigational drugs * History of other liver diseases (viral, autoimmune, drug-induced, alcohol) * Previous use of resmetirom in last 6 months * Significant renal impairment (eGFR \<30)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FIB-4 and CAP score/LSM on fibroscan | 6 months | Changes in liver fibrosis using non invasive markers |
| Changes in thyroid profile | 6 months | thyroid profile of each patient at baseline and at primary end point |
Countries
Pakistan
Contacts
Primary ContactHussain B Abidi, MBBS, MBA, CRCP
Outcome results
None listed