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

Phase 2

Active, not recruiting

• Conditions: Nonalcoholic Steatohepatitis (NASH)
• Interventions: Drug: ZSP1601; Drug: Placebo

• Registration Number: NCT05692492
• Lead Sponsor: Guangdong Raynovent Biotech Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-25
• Study First Submitted QC: 2023-01-10
• Study First Posted: 2023-01-20
• Study Start: 2023-06-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-06-16
• Study Completion: 2026-12-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZSP1601 100 mg BID	ZSP1601	-
ZSP1601 50mg BID	ZSP1601	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Change from baseline in liver chemistry（ALT,AST,GGT）	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
Percent of patients with steatohepatitis improvement and improvement of fibrosis by at least 1 stage	48 weeks
Percent of patients with steatohepatitis improvement and no worsening of fibrosis	48 weeks

Trial Locations

Locations (1)

NanFang Hospital; 🇨🇳 Guangzhou, China