Resmiterom Efficacy & Safety in Patients With MASH (REZMASH)

Nabiqasim Industries

Status and phase: Enrolling; Phase 4

Conditions: MASH - Metabolic Dysfunction-Associated Steatohepatitis

Treatments: Drug: Resmetirom

Study type: Interventional

Funder types: Industry

Identifiers

NCT07249788

NQ/HT/REZ/CT-003

Details and patient eligibility

About

Phase 4 clinical trial study aims to further evaluate the safety and therapeutic efficacy of Resmetirom in Pakistani patients with fibroscan proven MASH.

Enrollment: 165 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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165 participants in 1 patient group

MASH targeted therapy

Experimental group

Description:

MASH fibrosis stage 2 or 3

Treatment:

Drug: Resmetirom