NCT01277094已完成1 期
Multi-center, Double-blind, Randomized, Placebo-controlled Study of Selective 11 Beta-HSD1 Inhibition With RO5093151 for 12 Weeks to Investigate Efficacy, Safety and Pharmacokinetics of RO5093151 in Non-alcoholic Fatty Liver Disease and Its Metabolic Consequences.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
- 主要终点
- Change of liver fat content measured by magnetic resonance spectroscopy (MRS)
研究概览
简要总结
This multi-center, double-blind, randomized, placebo-controlled study will evaluate the change in liver fat content, pharmacokinetics and safety of RO5093151 in patients with non-alcoholic fatty liver disease. Patients will be randomized to receive either daily oral doses of RO5093151 or matching placebo. The anticipated time on study treatment is 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, 35-65 years of age
- •Hepatic steatosis assessed by magnetic resonance spectroscopy (MRS) with liver fat >5.56% at screening
- •Body mass index (BMI) >27 kg/m2 at screening
- •Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR) > 2.5 at screening
- •Agreement to maintain prior diet and exercise habits during the full course of study
排除标准
- •History of diabetes mellitus based on World Health Organization (WHO) criteria
- •Known polycystic ovary syndrome
- •Other liver disease e.g. chronic viral hepatitis, alcoholic liver disease, hemachromatosis, cirrhosis
- •Known autoimmune disease or chronic inflammatory disease
- •Myocardial infarction or stroke within 6 months prior to screening
- •Patients taking any anti-diabetic and/or weight-lowering medication currently or within the previous 3 months before screening
研究组 & 干预措施
1
Experimental
干预措施: RO5093151 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change of liver fat content measured by magnetic resonance spectroscopy (MRS)
时间窗: Week 12
次要结局
- Change in insulin resistance assessed by hyperinsulinemic euglycemic clamp(Week 12)
- Change in endogenous glucose production assessed by hyperinsulinemic euglycemic clamp(Week 12)
- Pharmacokinetic measures (max and min concentration, clearance, half-life, etc)(Week 12)
- Safety (incidence and nature of adverse events)(Week 12)
研究者
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