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NCT Number: NCT05692492

A Randomized, Double-blind, Placebo-controlled 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Nonalcoholic Steatohepatitis (NASH) Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NanFang Hospital

Guangzhou, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

ZSP1601

Drug

50mg BID

Placebo

Drug

Placebo

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

    Time frame: 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 outcomes

  1. 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

    Time frame: 48 weeks

  2. Percent of patients with steatohepatitis improvement and improvement of fibrosis by at least 1 stage

    Time frame: 48 weeks

  3. Percent of patients with steatohepatitis resolution and improvement of fibrosis by at least 1 stage

    Time frame: 48 weeks

  4. Percent of patients with steatohepatitis resolution and no worsening of fibrosis

    Time frame: 48 weeks

  5. Percent of patients with steatohepatitis improvement and no worsening of fibrosis

    Time frame: 48 weeks

  6. Change from baseline in liver fat content (LFC) as measured by MRI-PDFF

    Time frame: 48 weeks

  7. Change from baseline in liver chemistry（ALT,AST,GGT）

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2023
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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