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Clinical Trials/NCT07249788
NCT07249788RecruitingPhase 4

Clinical Evaluation of Safety and Efficacy of Resmiterom in Patients With MASH (Metabolic Dysfunction-Associated Steato-Hepatitis) A Prospective, Open-label, Interventional Study

Nabiqasim Industries (Pvt) Ltd1 site in 1 country165 target enrollmentStarted: October 17, 2025Last updated:
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Interventions

Trial Snapshot

Phase
Phase 4
Status
Recruiting
Enrollment
165
Locations
1
Primary Endpoint
FIB-4 and CAP score/LSM on fibroscan
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts 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)

Arms & Interventions

MASH targeted therapy

Experimental

MASH fibrosis stage 2 or 3

Intervention: Resmetirom (Drug)

Outcomes

Primary Outcomes

FIB-4 and CAP score/LSM on fibroscan

Time Frame: 6 months

Changes in liver fibrosis using non invasive markers

Changes in thyroid profile

Time Frame: 6 months

thyroid profile of each patient at baseline and at primary end point

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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