NL-OMON54111招募中3 期
The effect of semaglutide in non-cirrhotic non-alcoholic steatohepatitis - ESSENCE
ovo Nordisk0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
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 99（—）
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 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 both steatosis, lobular
- •inflammation and hepatocyte ballooning based on a central pathologist
- •evaluation of the baseline liver biopsy.
排除标准
- •- Positive HBsAg, positive anti-HIV, positive HCV-RNA at screening or any known
- •presence of HCV RNA or HBsAg within 2 years of screening (V2A).
- •- 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 (>20 g/day for women or
- •>30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders
- •Identification Test (AUDIT questionnaire).
- •- Treatment with vitamin E (at doses >=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 (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.
- •- 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.
- •- 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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