This study is designed to establish the effect of 2 doses of vonafexor on the kidney. This will be investigated in subjects with mild or moderate reduced estimated glomerular filtration rate (eGFR) and suspected MASH. In addition, the non-invasive multiparametric magnetic resonance imaging assessment of functional and structural changes in the kidney and in the liver will be investigated.
This is a phase 2, open-label, two-dose, randomized, parallel arms, single center study where subjects are participating for up to 32 weeks: * Screening: 4 weeks * Treatment: 16 weeks * Follow-up: 12 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Oral tablets
Oral tablets
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
RECRUITINGChange from baseline of mGFRiohexol at week 16
Time frame: 16 weeks
Change from baseline of eGFRcreatinine at week 16
Time frame: 16 weeks
Vonafexor plasma concentrations
Plasma concentrations pre-dose and post-dose which will be modelled against the MASH PopPK expected values
Time frame: 16 weeks
Change from baseline mGFRiohexol off treatment at week 24
Time frame: 24 weeks
Change from baseline of eGFRcreatinine on treatment at weeks 4, 8, 12 and off treatment at weeks 20, 24 and 28
Time frame: 28 weeks
Correlation of mGFRiohexol with eGFRcreatinine at baseline, on treatment at week 16 and off treatment at week 24
Time frame: 24 weeks
Levels and change in proteinuria in morning urine samples at baseline, on treatment at weeks 4, 8, 12, 16 with off treatment at weeks 20, 24 and 28
Time frame: 28 weeks
Treatment-emergent adverse events and serious adverse events
Time frame: 28 weeks
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