Clinical trial NCT05692492: A Randomized, Double-blind, Placebo-controlled Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
Official title: A Randomized, Double-blind, Placebo-controlled Phase 2b Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Nonalcoholic Steatohepatitis (NASH)
Lead sponsor: Guangdong Raynovent Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-01-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 48 weeks
Secondary outcomes:
measure: 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
timeFrame: 48 weeks
measure: Percent of patients with steatohepatitis improvement and improvement of fibrosis by at least 1 stage
timeFrame: 48 weeks
measure: Percent of patients with steatohepatitis resolution and improvement of fibrosis by at least 1 stage
timeFrame: 48 weeks
measure: Percent of patients with steatohepatitis resolution and no worsening of fibrosis
timeFrame: 48 weeks
measure: Percent of patients with steatohepatitis improvement and no worsening of fibrosis
timeFrame: 48 weeks
measure: Change from baseline in liver fat content (LFC) as measured by MRI-PDFF
timeFrame: 48 weeks
measure: Change from baseline in liver chemistry（ALT,AST,GGT）
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: NanFang Hospital
Study officials:
References: