The purpose of this research is to evaluate the efficacy and the safety of two doses of ZSP1601 for 48 weeks versus placebo in adult NASH patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
NanFang Hospital
Guangzhou, China
Percent of patients with improvement of steatohepatitis and no worsening of liver fibrosis or improvement in liver fibrosis greater than or equal to one stage and no worsening of the steatohepatitis
Percent of patients with improvement of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis on NASH-CRN Fibrosis Score or improvement in liver fibrosis greater than or equal to one stage and no worsening of the steatohepatitis
Time frame: 48 weeks
Percent of patients with resolution of steatohepatitis and no worsening of fibrosis or improvement of fibrosis by at least 1 stage and no worsening of steatohepatitis
Time frame: 48 weeks
Percent of patients with steatohepatitis improvement and improvement of fibrosis by at least 1 stage
Time frame: 48 weeks
Percent of patients with steatohepatitis resolution and improvement of fibrosis by at least 1 stage
Time frame: 48 weeks
Percent of patients with steatohepatitis resolution and no worsening of fibrosis
Time frame: 48 weeks
Percent of patients with steatohepatitis improvement and no worsening of fibrosis
Time frame: 48 weeks
Change from baseline in liver fat content (LFC) as measured by MRI-PDFF
Time frame: 48 weeks
Change from baseline in liver chemistry(ALT,AST,GGT)
Time frame: 48 weeks
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