Resmiterom Efficacy & Safety in Patients With MASH (REZMASH)

November 25, 2025 updated by: Nabiqasim Industries (Pvt) Ltd

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

165

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistan
        • Recruiting
        • Liver transplant center, Holy family hospital
        • Contact:
        • Contact:
          • Dr Anum Shakeel
        • Principal Investigator:
          • Dr. Muhammad Umar
        • Principal Investigator:
          • Dr Anum Shakeel
        • Sub-Investigator:
          • Dr. Bushra Khar
        • Sub-Investigator:
          • Dr Sadia Khan
        • Sub-Investigator:
          • Dr Tayyab Sb.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MASH targeted therapy
MASH fibrosis stage 2 or 3
Drug: Resmetirom
1st FDA approved MASH therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FIB-4 and CAP score/LSM on fibroscan
Time Frame: 6 months
Changes in liver fibrosis using non invasive markers
6 months
Changes in thyroid profile
Time Frame: 6 months
thyroid profile of each patient at baseline and at primary end point
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nabiqasim Industries (Pvt) Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2025

Primary Completion (Estimated)

October 16, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Estimated)

November 25, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NQ/HT/REZ/CT-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Its undecided for now will be updated laterwards

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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