Resmiterom Efficacy & Safety in Patients With MASH

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-17

Study Completion Date

2026-12-31

Brief Summary

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Phase 4 clinical trial study aims to further evaluate the safety and therapeutic efficacy of Resmetirom in Pakistani patients with fibroscan proven MASH.

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Detailed Description

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Conditions

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MASH - Metabolic Dysfunction-Associated Steatohepatitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MASH targeted therapy

MASH fibrosis stage 2 or 3

Group Type EXPERIMENTAL

Resmetirom

Intervention Type DRUG

1st FDA approved MASH therapy

Interventions

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Resmetirom

1st FDA approved MASH therapy

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No