EUCTR2020-003566-39-IT进行中（未招募）1 期
Efficacy and safety investigation of NNC0194-0499 co-administered withsemaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging,placebo-controlled trial - N/A
OVO NORDISK. S.P.A.0 个研究点目标入组 672 人开始时间: 2021年6月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 672
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
- •- Aged greater than or equal to 18 years at the time of signing informed consent.
- •- Histological evidence of non-alcoholic steatohepatitis (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 visit 1.
- •- Histological evidence of fibrosis stage 2, 3 or 4 according to the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) classification based on a central pathologist evaluation of the baseline liver biopsy.
- •- Histological non-alcoholic fatty liver disease (NAFLD) activity score (NAS) greater than or equal to 4 for subjects with F2/F3 or greater than or equal to 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.
- •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 504
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 168
排除标准
- •- Documented causes of chronic liver disease other than NAFLD.
- •- Positive Hepatitis B surface antigen (HBsAg), positive anti-human immunodeficiency virus (HIV), positive hepatitis C virus ribonucleic acid (HCV RNA) at screening visit 2A (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 greater than or equal to 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 (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 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 glucagon-like peptide-1 receptor agonist (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.
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