Resmetirom for MASH in Pakistani patients
Clinical Evaluation of Safety and Efficacy of Resmiterom in Patients With MASH (Metabolic Dysfunction-Associated Steato-Hepatitis) A Prospective, Open-label, Interventional Study
This trial will test whether resmetirom is safe and helps adults in Pakistan with MASH who also have metabolic risk factors.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 165 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nabiqasim Industries (Pvt) Ltd Industry-sponsored |
| Locations | 1 site (Rawalpindi, Punjab Province) |
| Trial ID | NCT07249788 on ClinicalTrials.gov |
What this trial studies
This is a Phase 4 interventional trial conducted at the Liver Transplant Center, Holy Family Hospital in Rawalpindi that gives resmetirom to patients with fibroscan‑proven MASH and metabolic comorbidities. Eligibility requires objective liver stiffness or steatosis measures (e.g., LSM ≥ 8.5 kPa, FAST ≥ 0.67, CAP ≥ 275 dB/m, or FIB‑4 > 1.3) and at least one metabolic condition such as type 2 diabetes, obesity, dyslipidemia, or hypertension. Key exclusions include cirrhosis, decompensated liver disease, chronic viral or other non‑MASH liver disease, recent resmetirom use, significant renal impairment, pregnancy, active substance abuse, and recent major cardiovascular events. Participants will be monitored for safety and changes in liver biomarkers and noninvasive fibrosis/steatosis measures while receiving resmetirom.
Who should consider this trial
Good fit: Adults in Pakistan with fibroscan‑proven MASH and at least one metabolic comorbidity (e.g., T2DM, obesity, dyslipidemia, hypertension) who do not have cirrhosis or significant renal impairment are ideal candidates.
Not a fit: Patients with cirrhosis, decompensated liver disease, chronic viral or other non‑MASH liver disease, recent major cardiovascular events, pregnancy, or severe renal impairment are unlikely to benefit from joining this trial.
Why it matters
Potential benefit: If successful, resmetirom could reduce liver fat and inflammation and improve liver-related biomarkers in patients with MASH.
How similar studies have performed: Previous clinical studies of resmetirom, including phase 2 and later-stage programs, have shown reductions in liver fat and improvements in some liver biomarkers, so this approach has supporting clinical data.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Rawalpindi, Punjab Province
- Liver transplant center, Holy family hospital — Rawalpindi, Punjab Province, Pakistan (Recruiting)
Study contacts
- Study coordinator: Hussain B Abidi, MBBS, MBA, CRCP
- Email: MDR.hussainabidi@gmail.com
- Phone: +923322583236
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.