A Randomized, Double-blind, Placebo-controlled Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)

Nonalcoholic Steatohepatitis (NASH) Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Phase 2b Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05692492
• Other study ID #: ZSP1601-22-03
• Status: Recruiting
• Phase: Phase 2
• Start date: June 3, 2023
• Est. completion date: December 16, 2026

Study information

• Verified date: June 2023
• Source: Guangdong Raynovent Biotech Co., Ltd
• Contact: Jinlin Hou
• Phone: 02061641888
• Email: jlhousmu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 16, 2026
• Est. primary completion date: June 16, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis (NASH)

Intervention

Drug:
• ZSP1601
50mg BID
• ZSP1601
100mg BID
• Placebo
Placebo

Locations

Country	Name	City	State
China	NanFang Hospital	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Raynovent Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Percent of patients with steatohepatitis improvement and improvement of fibrosis by at least 1 stage		48 weeks
Secondary	Percent of patients with steatohepatitis resolution and improvement of fibrosis by at least 1 stage		48 weeks
Secondary	Percent of patients with steatohepatitis resolution and no worsening of fibrosis		48 weeks
Secondary	Percent of patients with steatohepatitis improvement and no worsening of fibrosis		48 weeks
Secondary	Change from baseline in liver fat content (LFC) as measured by MRI-PDFF		48 weeks
Secondary	Change from baseline in liver chemistry(ALT,AST,GGT)		48 weeks