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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Nonalcoholic Steatohepatitis (NASH)
• Intervention / Treatment: Drug: Placebo; Drug: ZSP1601; Drug: ZSP1601

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jinlin Hou; Phone Number: 02061641888; Email: jlhousmu@163.com

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • Nanfang Hospital
    • Contact: Jinlin Hou; Phone Number: 020-61641888; Email: jlhousmu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: ZSP1601 50mg BID	Drug: ZSP1601; 50mg BID; Drug: ZSP1601; 100mg BID
Experimental: ZSP1601 100 mg BID	Drug: ZSP1601; 50mg BID; Drug: ZSP1601; 100mg BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Guangdong Raynovent Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2023
• Primary Completion (Estimated): June 16, 2026
• Study Completion (Estimated): December 16, 2026

Study Registration Dates

• First Submitted: December 25, 2022
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: ZSP1601-22-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No