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)

Liver transplant center, Holy family hospital

Rawalpindi, Punjab Province, Pakistan

View Full Details on ClinicalTrials.gov

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NCT07249788


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