A randomized, multi-center study evaluating MET409 (50 mg) alone or in combination with empagliflozin (10 mg) for 12 weeks. Assignment to MET409 will be double-blind and placebo-controlled. Empagliflozin will be incorporated into two of the treatment arms in an open-label manner.
Subjects assigned to receive empagliflozin will be dosed at 10 mg per day for the duration of the study. Approximately 30 subjects will be enrolled per treatment arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
MET409 Active (50mg)
MET409 Placebo (50mg)
Empagliflozin (10mg)
Metacrine Investigative Site
Fort Myers, Florida, United States
Metacrine Investigative Site
San Antonio, Texas, United States
Safety and tolerability of MET409 with or without empagliflozin (incidence of adverse events)
Incidence of Treatment-emergent adverse events, incidence of clinically significant changes in vital signs, abnormal laboratory safety tests, and abnormal ECGs.
Time frame: Up to 28 days after last dose
Pharmacological activity of MET409 alone or in combination with empagliflozin
Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)
Time frame: 16 weeks
Pharmacokinetic profile of MET409 alone or in combination with empagliflozin
Cmax
Time frame: 12 weeks
Pharmacokinetic profile of MET409 alone or in combination with empagliflozin
tmax
Time frame: 12 weeks
Pharmacokinetic profile of MET409 alone or in combination with empagliflozin
AUClast
Time frame: 12 weeks
Pharmacodynamic profile of MET409 alone or in combination with empagliflozin
Bile acid precursor : C4 (7αhydroxy-4-cholesten-3-one)
Time frame: 16 weeks
Pharmacodynamic profile of MET409 alone or in combination with empagliflozin
Bile acid precursor : Fibroblast growth factor 19 (FGF19)
Time frame: 16 weeks
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