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NCT Number: NCT07249788

Resmiterom Efficacy & Safety in Patients With MASH

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

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Key information

Conditions

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Liver transplant center, Holy family hospital

Rawalpindi, Punjab Province, Pakistan

Location status: Recruiting

Location contact

Dr Anum Shakeel

CONTACT

Dr Anum Shakeel

PRINCIPAL_INVESTIGATOR

Dr Sadia Khan

SUB_INVESTIGATOR

Dr Tayyab Sb.

SUB_INVESTIGATOR

Dr. Bushra Khar

SUB_INVESTIGATOR

Dr. Muhammad Umar

PRINCIPAL_INVESTIGATOR

Shanila Akhter

CONTACT

'[email protected]'

+92 307 6738460

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Resmetirom

Drug

1st FDA approved MASH therapy

Primary outcomes

  1. FIB-4 and CAP score/LSM on fibroscan

    Time frame: 6 months

    Changes in liver fibrosis using non invasive markers

  2. Changes in thyroid profile

    Time frame: 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Hussain B Abidi, MBBS, MBA, CRCP

CONTACT

[email protected]

+923322583236

Sponsors and collaborators

Lead sponsor

Nabiqasim Industries (Pvt) Ltd

Industry

Registry information

Official study title

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

Acronym: REZMASH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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