Recruiting NCT07249788
Resmiterom Efficacy & Safety in Patients With MASH
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Resmetirom.
- Who it may be relevant to
- Registry conditions: MASH - Metabolic Dysfunction-Associated Steatohepatitis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Evaluation of Safety and Efficacy of Resmiterom in Patients With MASH (Metabolic Dysfunction-Associated Steato-Hepatitis) A Prospective, Open-label, Interventional Study
Overview
Phase 4 clinical trial study aims to further evaluate the safety and therapeutic efficacy of Resmetirom in Pakistani patients with fibroscan proven MASH.
Interventions
- Drug Resmetirom
1st FDA approved MASH therapy
Primary outcome measures
- FIB-4 and CAP score/LSM on fibroscan [Time frame: 6 months]
- Changes in thyroid profile [Time frame: 6 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Liver transplant center, Holy family hospital — Rawalpindi
Publications
- 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 39735033
- 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 34329774
- 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 31727409
- 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 o PMID 38324483
Identifiers
NCT: NCT07249788 · NQ/HT/REZ/CT-003