jRCT2031210033进行中（未招募）不适用
The effect of semaglutide in subjects with non-cirrhotic non-alcoholic steatohepatitis(NN9931-4553) (ESSENCE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
- 主要终点
- Resolution of steatohepatitis and no worsening of liver fibrosis
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Histological evidence of NASH (non-alcoholic steatohepatitis) based on a central pathologist evaluation of the baseline liver biopsy. The baseline liver biopsy can be a historical biopsy obtained within 180 days prior to screening visit.
- •Histological evidence of fibrosis stage 2 or stage 3 according to the NASH CRN (Clinical Research Network) classification based on a central pathologist evaluation of the baseline liver biopsy.
- •A histological NAS (Non-alcoholic fatty liver disease Activity Score) above or equal to 4 with a score of 1 or more in both steatosis, lobular inflammation and hepatocyte ballooning based on a central pathologist evaluation of the baseline liver biopsy.
排除标准
- •Positive HBsAg (hepatitis B surface antigen), positive anti-HIV (human immunodeficiency virus), positive HCV-RNA (Hepatitis C virus RNA) at screening or any known presence of HCV RNA (ribonucleic acid) or HBsAg within 2 years of screening.
- •Documented causes of chronic liver disease other than Non-Alcoholic Fatty Liver Disease NAFLD.
- •Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at randomisation.
- •Known or suspected excessive consumption of alcohol (greater than 20 g/day for women or greater than 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire).
- •Treatment with vitamin E (at doses above or equal to 800 IU/day) or pioglitazone or medications approved for treatment of NASH which has not been at a stable dose in the opinion of the investigator in the period from 90 days prior to the screening visit. In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.
- •Treatment with GLP-1 RAs (glucagon-like peptide-1 receptor agonist) in the period from 90 days prior to the screening visit. In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, any treatment with GLP-1 RAs from time of biopsy until screening.
- •Treatment with glucose lowering agent(s) (other than GLP-1 RAs), lipid lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to the screening visit. In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.
结局指标
主要结局
Resolution of steatohepatitis and no worsening of liver fibrosis
Resolution of steatohepatitis and no worsening of liver fibrosis
Improvement in liver fibrosis and no worsening of steatohepatitis
Improvement in liver fibrosis and no worsening of steatohepatitis
Time to first liver-related clinical event
Time to first liver-related clinical event (composite endpoint)
次要结局
未报告次要终点
研究者
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