CTRI/2021/10/037678进行中（未招募）2 期
Efficacy and safety investigation of NNC0194-0499 co-administered withsemaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging,placebo-controlled trial
ovo Nordisk AS0 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
- 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.
- •2. Aged = 18 years at the time of signing informed consent. Japan, Republic of Korea and
- •Singapore: Please 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 V1.
- •4. Histological evidence of fibrosis stage 2, 3 or 4 according to the NASH CRN classification
- •based on a central pathologist evaluation of the baseline liver biopsy.
- •5. Histological NAFLD activity score (NAS) = 4 for subjects with F2/F3 or = 3 for subjects with
- •F4 based on a central pathologist evaluation of the baseline liver biopsy. All subjects must have
- •a score of 1 or more in steatosis, lobular inflammation and hepatocyte ballooning.
排除标准
- •Documented causes of chronic liver disease other than NAFLD.
- •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 more than grade 1, variceal bleeding, hepatic encephalopathy,
- •spontaneous bacterial peritonitis or liver transplantation at V2A.
- •Presence or history of gastro-oesophageal varices = grade 2 at V2A. For subjects with F4, an
- •oesophagogastroduodenoscopy performed no more than 52 weeks prior to V2A must be
- •available at V2A.
- •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
- •the 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 V2A. In addition, for subjects with a historical liver biopsy
- •taken more than 90 days prior to V2A, treatment should be at a stable dose in the opinion of the
- •investigator from time of biopsy until V2A.
- •Treatment with GLP-1 RAs within 90 days prior to V2A. Subjects with a historical liver biopsy
- •taken more than 90 days prior to V2A are excluded if they receive treatment with GLP-1 RAs
- •from time of biopsy until 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 V2A. In addition, for subjects with a historical liver biopsy taken more than 90 days
- •prior to V2A, treatment should be at a stable dose in the opinion of the investigator from time of
- •biopsy until V2A.
研究者
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