A randomized, double-blind, placebo-controlled study to evaluate MET642 in NASH patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
215
Pinnacle Research
San Antonio, Texas, United States
Adverse Events
Incidences of treatment-emergent adverse events
Time frame: Up to 28 days after last dose
Vital Signs
Incidences of clinically significant changes in vital signs
Time frame: Up to 28 days after last dose
Laboratory tests
Incidences of clinically significant changes in laboratory tests
Time frame: Up to 28 days after last dose
ECG
Incidences of clinically significant changes in ECGs
Time frame: Up to 28 days after last dose
Pharmacokinetic Profile of MET642
Cmax
Time frame: 16 weeks
Pharmacodynamic Profile of MET642
C4 concentrations
Time frame: 16 weeks
Pharmacological Activity of MET642
Measure of changes in liver fat using MRI-PDFF
Time frame: 20 weeks
Pharmacokinetic Profile of MET642
Tmax
Time frame: 16 weeks
Pharmacokinetic Profile of MET642
T1/2
Time frame: 16 weeks
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Pharmacokinetic Profile of MET642
AUC0-inf
Time frame: 16 weeks
Pharmacodynamic Profile of MET642
FGF19 concentrations
Time frame: 16 weeks
Pharmacodynamic Profile of MET642
Bile Acids concentrations
Time frame: 16 weeks