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

What this Trial Is About

Researchers are evaluating the safety and therapeutic effects of Resmetirom in Pakistani patients diagnosed with Metabolic Dysfunction-Associated Steatohepatitis (MASH) confirmed by fibroscan. This Phase 4 clinical trial focuses on patients with stage 2 or 3 liver fibrosis due to MASH, aiming to gather further evidence about Resmetirom's impact and safety in this population. Participants will receive Resmetirom, the first FDA-approved drug for MASH therapy, in an open-label, non-randomized setting. The study is prospective and interventional, targeting patients with metabolic comorbidities such as type 2 diabetes, obesity, dyslipidemia, or hypertension. The treatment period and follow-up last for six months during which key liver-related scores and thyroid function will be monitored. During the trial, participants will undergo assessments including Fibroscan measurements (FIB-4 and CAP score/LSM) and thyroid profile tests at the six-month mark. Researchers will track changes in these liver and thyroid parameters to evaluate the drug's effects. The study excludes people with certain liver diseases, recent use of Resmetirom, or significant kidney impairment. Participant safety and treatment effects will be closely monitored throughout the study period, which runs until the end of 2026.

Resmiterom Efficacy & Safety in Patients With MASH