CTRI/2021/03/032022进行中（未招募）3 期
The effect of semaglutide in subjects with non-cirrhotic non-alcoholic steatohepatitis - ESSENCE
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试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 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
- •Subjects are eligible to be included in the trial only if all of the following criteria apply:
- •1. Informed consent obtained before any trial-related activities. Trial-related activities are any
- •procedures that are carried out as part of the trial, including activities to determine suitability for
- •the trial except for protocol-defined pre-screening activities, which require a separate informed
- •consent. Ireland: See local requirements in Appendix 9 (Section 10.9).
- •2. Age above or equal to 18 years at the time of signing informed consent. Japan, South Korea
- •and Taiwan: See local requirements in Appendix 9 (Section 10.9).
- •3. 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).
- •4. 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.
- •5. 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.
- •China: See local requirements in Appendix 9 (Section 10.9).
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
- •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 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 (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.
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