NCT07249788

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for phase_4

Timeline
8mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Oct 2025Dec 2026

Study Start

First participant enrolled

October 17, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

12 months

First QC Date

November 18, 2025

Last Update Submit

November 25, 2025

Conditions

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Keywords

ResmetiromMASHSafetyEfficacy

Outcome Measures

Primary Outcomes (2)

  • FIB-4 and CAP score/LSM on fibroscan

    Changes in liver fibrosis using non invasive markers

    6 months

  • Changes in thyroid profile

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

    6 months

Study Arms (1)

MASH targeted therapy

EXPERIMENTAL

MASH fibrosis stage 2 or 3

Drug: Resmetirom

Interventions

ResmetiromDRUG

1st FDA approved MASH therapy

MASH targeted therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liver transplant center, Holy family hospital

Rawalpindi, Punjab Province, Pakistan

RECRUITING

Related Publications (4)

  • Patel RH, Parikh C, Upadhyay H, Sonaiya S, Ramnath P, Singh S, Patel U, Kothari T. Resmetirom in the Management of Metabolic Dysfunction-Associated Steatohepatitis (MASH): A Comprehensive Review of Current Evidence and Therapeutic Potential. Cureus. 2024 Nov 29;16(11):e74772. doi: 10.7759/cureus.74772. eCollection 2024 Nov.

    PMID: 39735033BACKGROUND

  • Younossi ZM, Stepanova M, Taub RA, Barbone JM, Harrison SA. Hepatic Fat Reduction Due to Resmetirom in Patients With Nonalcoholic Steatohepatitis Is Associated With Improvement of Quality of Life. Clin Gastroenterol Hepatol. 2022 Jun;20(6):1354-1361.e7. doi: 10.1016/j.cgh.2021.07.039. Epub 2021 Jul 27.

    PMID: 34329774BACKGROUND

  • Harrison SA, Bashir MR, Guy CD, Zhou R, Moylan CA, Frias JP, Alkhouri N, Bansal MB, Baum S, Neuschwander-Tetri BA, Taub R, Moussa SE. Resmetirom (MGL-3196) for the treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2019 Nov 30;394(10213):2012-2024. doi: 10.1016/S0140-6736(19)32517-6. Epub 2019 Nov 11.

    PMID: 31727409BACKGROUND

  • Harrison SA, Bedossa P, Guy CD, Schattenberg JM, Loomba R, Taub R, Labriola D, Moussa SE, Neff GW, Rinella ME, Anstee QM, Abdelmalek MF, Younossi Z, Baum SJ, Francque S, Charlton MR, Newsome PN, Lanthier N, Schiefke I, Mangia A, Pericas JM, Patil R, Sanyal AJ, Noureddin M, Bansal MB, Alkhouri N, Castera L, Rudraraju M, Ratziu V; MAESTRO-NASH Investigators. A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis. N Engl J Med. 2024 Feb 8;390(6):497-509. doi: 10.1056/NEJMoa2309000.

    PMID: 38324483RESULT

Related Links

MeSH Terms

Interventions

resmetirom

Central Study Contacts

Hussain B Abidi, MBBS, MBA, CRCP

CONTACT

+923322583236MDR.hussainabidi@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start

October 17, 2025

Primary Completion (Estimated)

October 16, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 3, 2025

Record last verified: 2025-11

Locations

PA(1)