NCT04505436已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) Treatment for 12 Months in Subjects With Biopsy Confirmed NASH
Hanmi Pharmaceutical Company Limited112 个研究点 分布在 2 个国家目标入组 215 人开始时间: 2020年7月31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
- 已完成
- 发起方
- 入组人数
- 215
- 试验地点
- 112
- 主要终点
- pharmacodynamic (PD) effect of HM15211
研究概览
简要总结
This study is a phase 2 study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects with Biopsy Confirmed NASH
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •United States Sites: Adults ≥ 18 to ≤ 70 years.
- •Korean Sites: Adults ≥ 19 to ≤ 70 years.
- •BMI ≥ 18 kg/m2, with stable body weight (defined as change < 5%) by history for 3 months prior to screening or since baseline liver biopsy, whichever is earlier.
- •Subjects have a diagnosis of non-cirrhotic NASH with liver fibrosis (Fibrosis stage F1-F3) confirmed by liver biopsy within 6 months of Day -
- •MRI-PDFF performed at screening with ≥ 8% steatosis.
排除标准
- •Subjects with a history of active or chronic liver disease, including alcoholic liver disease, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, human immunodeficiency virus (HIV).
- •Any history of clinically significant chronic liver disease including esophageal varices, ascites, hepatic encephalopathy, splenomegaly, or any hospitalization for treatment of chronic liver disease; or Model for End Stage Liver Disease >
- •Recent (within 3 months of baseline biopsy) use of therapies associated with development of NAFLD (e.g., systemic corticosteroids, methotrexate, tamoxifen, aromatase inhibitors, amiodarone, or long-term use of tetracyclines).
- •Type 1 diabetes subjects, or T2DM subjects on GLP-1 receptor agonist therapy, or other therapies not allowed for this study
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo of HM15211 (Drug)
HM15211
Experimental
干预措施: HM15211 (Drug)
结局指标
主要结局
pharmacodynamic (PD) effect of HM15211
时间窗: 12 months
Proportion of subjects who achieve resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis
次要结局
未报告次要终点
研究者
研究点 (112)
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