Nonalcoholic Steatohepatitis (NASH)
Conditions
Brief summary
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.
Interventions
DRUGZSP1601
50mg BID
DRUGPlacebo
Placebo
Sponsors
Guangdong Raynovent Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. NASH histological diagnosis on a liver biopsy performed ≤ 24 weeks before randomization, and NAS≥4 (at least 1 point each in inflammation and ballooning), and fibrosis score F2 or F3, and no other chronic liver disease 2. Subjects having given her/his written informed consent 3. Good compliance with the protocol and agree to have liver biopsy performed 4. Subjects (including their partners) agreed to use effective contraception throughout the study period and up to 24 weeks after discontinuation
Exclusion criteria
1. History of cirrhosis or liver biopsy suggestive of cirrhosis 2. Metabolic surgery or new technology treatment for weight loss within 5 years prior to randomization or planned during the study period 3. Type 1 diabetes 4. HIV infection 5. Patients with severe or uncontrollable underlying diseases, unsuitable for treatment with ZSP1601, unable to complete study follow-up, or likely to affect the evaluation of trial results judged by investigator 6. Previous malignancy within 5 years 7. Treatment with hepatoprotective drugs 8. Excessive alcohol consumption for 12 or more consecutive weeks within 1 year prior to screening 9. Pregnant and lactating women or those with a positive serum pregnancy test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 48 weeks | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Percent of patients with steatohepatitis improvement and improvement of fibrosis by at least 1 stage | 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 resolution of steatohepatitis and no worsening of fibrosis or improvement of fibrosis by at least 1 stage and no worsening of steatohepatitis | 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 |
| Percent of patients with steatohepatitis improvement and no worsening of fibrosis | 48 weeks |
Countries
China
Outcome results
None listed