This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel group, multiple arm, multicenter study of 3 different doses of HPG1860 versus placebo in subjects with biopsy-confirmed or phenotypic NASH.
This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel group, multiple arm, multicenter study of 3 different doses of HPG1860 versus placebo in subjects with biopsy-confirmed or phenotypic NASH. Screening will occur up to 5 weeks prior to randomization; all eligible subjects will have baseline hepatic imaging during Screening, prior to randomization. Approximately 80 eligible subjects will be randomized 1:1:1:1 on Day 1/Week 0 (T1) to receive either HPG1860 3 mg (n = 20), or 5 mg (n = 20), or 8 mg (n = 20), or placebo (n = 20) for 12 weeks. Following a preplanned interim analysis, a dose cohort may be dropped and/or added.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
89
South Texas Research Institute (STRI)
Texas City, Texas, United States
Safety and tolerability of treatment
Number of participants Treatment-emergent adverse events (TEAEs)
Time frame: 12 weeks
liver fat content
Change from baseline (CFB) in liver fat content (LFC) measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at Week 12
Time frame: 12 week
Percentage of subjects with ≥30% reduction in LFC from baseline
measured by MRI-PDFF at Week 4 and Week 12
Time frame: 4 week and 12 week
Change from baseline (CFB) in liver fat content (LFC) at 4 week
measured by MRI-PDFF at Week 4
Time frame: 4 week
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