A Single Center, Randomized, Open Label, Parallel Group, Phase 3 Study to Evaluate the Efficacy of Dapagliflozin in Subjects With Nonalcoholic Fatty Liver Disease
试验速览
- 阶段
- 3 期
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Safety Outcome Measure
研究概览
简要总结
This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. This is a principal investigator initiate study. This study is supported by Liver Disease Prevention & Treatment Research Foundation. Dapagliflozin will be provided free of charge by AstraZeneca.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dapagliflozin
This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease.
干预措施: Dapagliflozin 10Mg Tab (Drug)
Non-used drug
This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety Outcome Measure
时间窗: 6 months
Patients who meet all inclusion criteria and none of the exclusion criteria and are not screen failures for reasons listed above will be randomized in a 1:1 ratio to either receive 10 mg per day dapagliflozin or enter control group at Visit 2.
次要结局
未报告次要终点