Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZSP1601 50mg BID | Experimental |
| |
| ZSP1601 100 mg BID | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZSP1601 | Drug | 50mg BID |
| |
| ZSP1601 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 48 weeks | |
| Percent of patients with steatohepatitis improvement and improvement of fibrosis by at least 1 stage |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NanFang Hospital | Guangzhou | China |
Not provided
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
100mg BID |
|
| Placebo | Drug | Placebo |
|
| 48 weeks |
| Percent of patients with steatohepatitis resolution and improvement of fibrosis by at least 1 stage | 48 weeks |
| Percent of patients with steatohepatitis resolution and no worsening of fibrosis | 48 weeks |
| Percent of patients with steatohepatitis improvement and no worsening of fibrosis | 48 weeks |
| Change from baseline in liver fat content (LFC) as measured by MRI-PDFF | 48 weeks |
| Change from baseline in liver chemistry(ALT,AST,GGT) | 48 weeks |