JPRN-jRCT2041220100招募中2 期
A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of GSK4532990 in Adults With Pre-Cirrhotic Non-Alcoholic Steatohepatitis - HORIZO
Okawa Yasutoshi0 个研究点目标入组 246 人开始时间: 2022年11月28日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 246
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •Body Mass Index (BMI) >-25 kilogram per meter square (kg/m2) (all ethnic origins) except for Asian participants who qualify for the study with BMI >-23 kg/m2 at Screening.
- •- In the opinion of the investigator, there are features of metabolic syndrome and NAFLD is the most likely cause of liver disease.
- •- A liver biopsy at baseline showing NAFLD Activity Score (NAS) >-4 with at least 1 point each in steatosis, inflammation and ballooning and Fibrosis CRN score of 3.
- •- Able and willing to comply with all study assessments, including a liver biopsy at Week 52.
排除标准
- •- Cirrhosis (based on screening biopsy or historical biopsy showing definitive cirrhosis).
- •- Current alcohol consumption >-14 standard drinks (24 units, 196 g ethanol) per week for females or >-21 standard drinks (37 units, 294 g ethanol) per week for males.
- •- Weight reduction surgery (including gastric banding and intragastric balloon insertion) within 2 years of Screening 1.
- •- History of cancer within previous 2 years from Screening 1, except adequately resected non-melanoma skin cancer.
研究者
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