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

NCT05692492 | Active Not Recruiting Phase 2

• 1 other identifier: ZSP1601-22-03
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonalcoholic Steatohepatitis (NASH)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (3)

ZSP1601 50mg BID

EXPERIMENTAL

Drug: ZSP1601

ZSP1601 100 mg BID

EXPERIMENTAL

Drug: ZSP1601

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ZSP1601 DRUG

50mg BID

ZSP1601 50mg BID

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Subjects having given her/his written informed consent
• Good compliance with the protocol and agree to have liver biopsy performed
• Subjects (including their partners) agreed to use effective contraception throughout the study period and up to 24 weeks after discontinuation

You may not qualify if:

• History of cirrhosis or liver biopsy suggestive of cirrhosis
• Metabolic surgery or new technology treatment for weight loss within 5 years prior to randomization or planned during the study period
• Type 1 diabetes
• HIV infection
• 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
• Previous malignancy within 5 years
• Treatment with hepatoprotective drugs
• Excessive alcohol consumption for 12 or more consecutive weeks within 1 year prior to screening
• Pregnant and lactating women or those with a positive serum pregnancy test.

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

NanFang Hospital

Guangzhou, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2022
• First Posted: January 20, 2023
• Study Start: June 3, 2023
• Primary Completion (Estimated): June 16, 2026
• Study Completion (Estimated): December 16, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

CN (1)