NL-OMON47918已完成2 期
Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis. - SEMA-NASH
ovo Nordisk0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
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
- 年龄范围
- 18 至 64（—）
入选标准
- •* Informed consent obtained before any trial-related activities.
- •* Male or female, aged 18-75 years (both inclusive)
- •* Histologic evidence of NASH based on central pathologist evaluation
- •* A histological NAS * 4 with a score of 1 or more in each sub-component of the score based on central pathologist evaluation.
- •* NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation.
排除标准
- •* Known or suspected abuse of alcohol, alcohol dependence or narcotics.
- •* Diagnosis of type 1 diabetes according to medical records.
- •* HbA1c > 10% at screening.
- •* History or presence of pancreatitis (acute or chronic).
- •* Calcitonin * 50 ng/L at screening.
- •* Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- •* Body Mass Index (BMI) * 25.0 kg/m2 at the screening visit.
- •* Female who is pregnant, breast-feeding or intends to become pregnant.
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