EUCTR2016-000685-39-FR进行中（未招募）1 期
Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis.A 72-week randomised, double-blind, placebo-controlled, six-armed parallel group, multi-centre, multinational trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 372
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
- •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. Male or female, aged 18-75 years (both inclusive) (for Japan: male or female aged 20-75 years (both inclusive) at the time of signing informed consent.
- •3. Local histological diagnosis of NASH followed by histological confirmation of NASH based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening.
- •4. A histological NAS > = 4 with a score of 1 or more in each sub-component of the score based on central pathologist evaluation.
- •5. NASH fibrosis stage 2 or 3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation.
- •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 316
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 56
排除标准
- •1. Known or suspected abuse of alcohol (> 20 g/day for women or > 30 g/day for men), alcohol dependence* or narcotics. (* = assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)).
- •2. Diagnosis of type 1 diabetes according to medical records.
- •3. HbA1c > 9% at screening.
- •4. History or presence of pancreatitis (acute or chronic).
- •5. Calcitonin = 50 ng/L at screening.
- •6. Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative.
- •7. Body Mass Index (BMI) = 25.0 or = 45.0 kg/m^2 at the screening visit.
- •8. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
研究者
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