RecruitingPhase 4NCT07249788
Resmiterom Efficacy & Safety in Patients With MASH
Clinical Evaluation of Safety and Efficacy of Resmiterom in Patients With MASH (Metabolic Dysfunction-Associated Steato-Hepatitis) A Prospective, Open-label, Interventional Study
Sponsor
Nabiqasim Industries (Pvt) Ltd
Enrollment
165 participants
Start Date
Oct 17, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
Phase 4 clinical trial study aims to further evaluate the safety and therapeutic efficacy of Resmetirom in Pakistani patients with fibroscan proven MASH.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria6
- • 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 Criteria9
- • 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)
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Interventions
DRUGResmetirom
1st FDA approved MASH therapy
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07249788
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