CTIS2023-509912-27-00进行中（未招募）1 期
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis - BIO89-100-131
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 89bio Inc.
- 入组人数
- 1,050
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •1_Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF), 2_Biopsy-confirmed MASH with fibrosis stage F2 or F3 per NASH CRN System and NAS >=4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation (qualifying biopsy must be either within 6 months of screening visit ,with additional requirements, or obtained during screening period), 3_Body mass index (BMI) at Screening >=25.0 (>=23 for Asian subjects) and <50.0 kg/m2
排除标准
- •1_Chronic liver diseases other than MASH/NASH, 2_History or evidence of cirrhosis, 3_Have type 1 diabetes or poorly controlled type 2 diabetes, 4_Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=250 U/L, Subjects taking vitamin E (>400 IU/day) must be on stable dose for at least 6 months prior to screening
研究者
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