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临床试验/CTRI/2023/03/051029
CTRI/2023/03/051029招募中2 期

17 B-Hydroxysteroid Dehydrogenase type 13 Minimization for the treatment of NASH (HORIZON): 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

GSK Research and Development Limite0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
招募中
发起方

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

入选标准

  • BMI = 25 KG per meter square (all ethnic origins) except for Asian Participants who qualify for the study with BMI =23Kg/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. Able and willing to comply with all the study assessments including a liver biopsy at week52.

排除标准

  • 1) Cirrhosis (based on screening biopsy or historical biopsy showing definitive cirrhosis).
  • 2) Current alcohol consumption =14 standard drinks (24 units, 196 g ethanol) per week for females or =21 standard drinks (37 units, 294g ethanol) per week for males.
  • 3) Weight reduction surgery (including gastric banding and intragastric balloon insertion) within 2 years of Screening 1.
  • 4) History of cancer within previous 2 years from Screening 1, except adequately resected non-melanoma skin cancer.

研究者

发起方
GSK Research and Development Limite

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