A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IIa Clinical Trial to Evaluate the Safety and Explore the Efficacy of J2H-1702 for Non-alcoholic Steatohepatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 12
- 主要终点
- Changes from baseline in results on MRI-PDFF at week12.
研究概览
简要总结
The study aims to evaluate the safety of J2H-1702 compared to the placebo and explore the efficacy of J2H-1702 at Week 12 timepoint after administration compared to baseline in patients with NASH.
详细描述
Subjects will be randomized to the study group 1 (J2H-1702 A mg), study group 2 (J2H-1702 B mg), study group 3 (J2H-1702 C mg), or control group (placebo of J2H-1702) in a 1:1:1:1 ratio and administered the investigational product (IP) for 12 weeks. After the IP administration, the safety and efficacy will be evaluated at V4, V8 and V12 (end of treatment, EOT).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A subject aged ≥19 years to ≤75 years
- •Meeting all of the following criteria:
- •Screening MRI-PDFF with ≥8% steatosis
- •Screening MRE with liver stiffness ≥2.5 kPa
- •ALT or AST ≤250 IU/L at screening
- •Willing to maintain the same lifestyle (exercise, alcohol consumption, diet, etc.) during the study
- •Voluntarily provide written consent to participate in the study
排除标准
- •A subject who has past or current history of liver diseases
- •A subject who has the following medical or surgical history
- •Severe cardiac diseases, Malignant tumors, Clinically significant hypersensitivity reaction to any drugs containing components of the 11β-HSD1 inhibitor or same class
- •A subject who has the following concomitant diseases
- •liver disease, uncontrolled hypertension, uncontrolled DM, etc.
- •A subject who has taken the following medications
- •Systemic glucocorticoids, NSAIDs, any medication that may induce fatty liver disease, etc.
- •A subject who has taken IP of another study
- •A subject who does not agree with appropriate methods of contraception
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
J2H-1702 C mg
干预措施: J2H-1702 (Drug)
J2H-1702 A mg
干预措施: J2H-1702 (Drug)
J2H-1702 B mg
干预措施: J2H-1702 (Drug)
结局指标
主要结局
Changes from baseline in results on MRI-PDFF at week12.
时间窗: Baseline and week12
The liver fat content(%) on MRI-PDFF at week 12 after administration of the IP are evaluated.
Changes from baseline in results on MRE at week12.
时间窗: Baseline and week12
The liver fibrosis (kPa) on MRE at week 12 after administration of the IP are evaluated.
次要结局
未报告次要终点