EUCTR2019-004594-44-IE进行中（未招募）1 期
The effect of semaglutide in subjects with non-cirrhotic non-alcoholic steatohepatitis - ESSENCE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age above or equal to 18 years at the time of signing informed consent.
- •Histological evidence of NASH 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
- •the screening visit (V1).
- •Histological evidence of fibrosis stage 2 or stage 3 according to the NASH CRN classification
- •based on a central pathologist evaluation of the baseline liver biopsy.
- •A histological NAS = 4 with a score of 1 or more in steatosis, lobular inflammation and
- •hepatocyte ballooning based on a central pathologist evaluation of the baseline liver biopsy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 960
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •Documented causes of chronic liver disease other than non-alcoholic fatty liver disease
- •Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known
- •presence of HCV RNA or HBsAg within 2 years of screening (V2A).
- •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 greater than 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 period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in from time of biopsy until screening.
- •Treatment with GLP-1 RAs in the period from 90 days prior to the screening visit (V2A). 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 (V2A).
- •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 (V2A). 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.
研究者
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