NCT05692492进行中（未招募）2 期
A Randomized, Double-blind, Placebo-controlled Phase 2b Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
Guangdong Raynovent Biotech Co., Ltd1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2023年6月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
ZSP1601 50mg BID
Experimental
干预措施: ZSP1601 (Drug)
ZSP1601 100 mg BID
Experimental
干预措施: ZSP1601 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
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
时间窗: 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
次要结局
- 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)
研究者
研究点 (1)
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