Resmiterom Efficacy & Safety in Patients With MASH
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNabiqasim Industries (Pvt) Ltd
About this trial
Phase 4 clinical trial study aims to further evaluate the safety and therapeutic efficacy of Resmetirom in Pakistani patients with fibroscan proven MASH.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• At least one metabolic comorbidity (e.g., T2DM, obesity, dyslipidemia and hypertension)
LSM ≥ 8.5kpa And/or
FAST score ≥0.67 And/or
FibroScan CAP ≥ 275 dB/m And/or
Disqualifiers
• History of drug addiction and alcoholism
Cirrhosis or decompensated liver disease
Chronic viral hepatitis HBV, HCV)
MACE including MI, Stroke, PE etc.
Trial design
Design model
Single group
Treatments tested in this trial
Resmetirom
Drug1st FDA approved MASH therapy
Treatment groups
165 Participants
are divided into 1 treatment groupGroup A: MASH targeted therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
FIB-4 and CAP score/LSM on fibroscan
Changes in liver fibrosis using non invasive markers
Time frame
6 months2
Changes in thyroid profile
thyroid profile of each patient at baseline and at primary end point
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov