MASH - Metabolic Dysfunction-Associated SteatohepatitisPhase 4REZMASHNCT07249788
Resmiterom Efficacy & Safety in Patients With MASH
A Phase 4 study testing Resmetirom in people with MASH - Metabolic Dysfunction-Associated Steatohepatitis, run by Nabiqasim Industries (Pvt) Ltd at 1 site in Pakistan.
Trial summary
Phase 4 clinical trial study aims to further evaluate the safety and therapeutic efficacy of Resmetirom in Pakistani patients with fibroscan proven MASH. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- MASH - Metabolic Dysfunction-Associated Steatohepatitis
- What is being tested?
- Resmetirom
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Oct 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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
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- History of other liver diseases (viral, autoimmune, drug-induced, alcohol)
- Previous use of resmetirom in last 6 months
- Significant renal impairment (eGFR <30)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Liver transplant center, Holy family hospital
Rawalpindi, Punjab Province
Shanila Akhter, +92 307 6738460, 'shanilaakhter105@gmail.com'
Dr Anum Shakeel
About this study
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
Phase 4 clinical trial study aims to further evaluate the safety and therapeutic efficacy of Resmetirom in Pakistani patients with fibroscan proven MASH.
- Being tested
- Resmetirom
- Keywords
- Resmetirom, MASH, Safety, Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResmetiromDrug
1st FDA approved MASH therapy
| Study group | Role | What they receive |
|---|---|---|
| MASH targeted therapy | Experimental | MASH fibrosis stage 2 or 3 Receives: Drug: Resmetirom |
What is being measured
The primary outcome is the main question the study is designed to answer.
FIB-4 and CAP score/LSM on fibroscan
Changes in liver fibrosis using non invasive markers
Measured: 6 months
Changes in thyroid profile
thyroid profile of each patient at baseline and at primary end point
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start17 Oct 2025
- Primary completion16 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MASH - Metabolic Dysfunction-Associated SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nabiqasim Industries (Pvt) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249788
- Sponsor's protocol ID
- NQ/HT/REZ/CT-003
- Acronym
- REZMASH
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Its undecided for now will be updated laterwards
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.
PubMed 39735033Younossi 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.
PubMed 34329774Harrison 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.
PubMed 31727409Harrison 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.
PubMed 38324483
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07249788
- Acronym / sponsor ID
- REZMASH / NQ/HT/REZ/CT-003
- Keywords
- Resmetirom, MASH, Safety, Efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Nabiqasim Industries (Pvt) LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- 16 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MASH targeted therapy | Experimental | Drug: ResmetiromMASH fibrosis stage 2 or 3 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • At least one metabolic comorbidity (e.g., T2DM, obesity, dyslipidemia and hypertension)
Key exclusion criteria (9 listed)
- • History of drug addiction and alcoholism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resmetirom1st FDA approved MASH therapy | Drug | MASH targeted therapy |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Background: PubMed 39735033Patel 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.
- Background: PubMed 34329774Younossi 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.
- Background: PubMed 31727409Harrison 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.
- Results publication: PubMed 38324483Harrison 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Its undecided for now will be updated laterwards
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Resmetirom in people with MASH - Metabolic Dysfunction-Associated Steatohepatitis, run by Nabiqasim Industries (Pvt) Ltd at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hussain B Abidi, MBBS, MBA, CRCP (+923322583236, MDR.hussainabidi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FIB-4 and CAP score/LSM on fibroscan (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07249788, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.