jRCT2011240020进行中（未招募）不适用
Effects of NNC0194-0499 alone and in combination with semaglutide, of semaglutide alone, and of cagrilintide alone and in combination with semaglutide on liver damage and alcohol use in people with alcohol-related liver disease(NN9500-7730)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 主要终点
- Change in Enhanced Liver Fibrosis (ELF)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- •Age 18 years or above, and at the legal drinking age according to local requirements at the time of signing the informed consent.
- •Patient-reported history of alcohol overuse for >=5 years with an alcohol history of a mean of >=50 grams (male)/40 grams (female) pr day for the last year leading up to the time of signing informed consent.
- •ELF >=9.8 units.
排除标准
- •Known or suspected hypersensitivity to study intervention(s) or related products.
- •Previous participation (i.e., signed informed consent) in this study. If exclusion criteria 7 is met (Vibration Controlled Transient Elastography liver stiffness measurement (LSM) is >= 25 kPa), a single rescreening is possible at the investigators discretion.
- •Documented causes of chronic liver disease other than Alcohol-related liver disease (ALD).
- •Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V1) or any known presence of HCV RNA or HBsAg within 2 years of screening (V1).
- •Presence or history of ascites more than grade 1, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or liver transplantation at screening (V1).
- •Alcohol hepatitis at randomisation (as defined by NIAAA).
- •Vibration Controlled Transient Elastography LSM >= 25 kPa at V
- •If participants meet this criterion, rescreening is allowed once.
- •Presence or history of gastro-oesophageal varices >= grade 2 at V
- •For participants with LSM >= 20 kPa as well as blood platelets count < 150,000 per uL of blood an oesophagogastroduodenoscopy performed no more than 52 weeks prior to V2 must be available at V
- •Grade 2: varices projecting by one-third of the luminal diameter that cannot be compressed with air insufflation
- •BMI <= 25 kg/m2
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method with low user-dependency.
结局指标
主要结局
Change in Enhanced Liver Fibrosis (ELF)
时间窗: From baseline (week 0) to week 28
The primary clinical question of interest is: What is the difference between means in the composite change in ELF score from baseline to week 28 in patients with alcohol-related liver disease, treated with each of the active treatments versus placebo, irrespective of adherence to investigational medicinal product and with use of ancillary therapy.
次要结局
未报告次要终点
研究者
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