NCT03723252已完成3 期
Efficacy and Safety of Dapagliflozin in Non-alcoholic Steatohepatitis: a Multicentre, Randomized, Placebo-controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Improvement in scored liver histological improvement over 12 months
研究概览
简要总结
This is a multicentre, randomized, placebo-controlled trial to assess the efficacy and safety of dapagliflozin on improving non-alcoholic steatohepatitis as determined by liver biopsies and metabolic risk factors.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged≥18 years;
- •Non-alcoholic steatohepatitis as determined by liver biopsies within 6 months;
- •Patients with T2DM at screening had to have stable glycaemic control (HbA1c <9.5%) .
排除标准
- •Significant alcohol consumption in the past six months (Consumed more than 20 g/day for women or 30 g/day for men);
- •A history of alcoholic liver disease, chronic viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, cirrhosis, and liver cancer;
- •Obstructive biliary disease;
- •Having any medical condition that would affect metabolism (i.e. Cushing syndrome, known hyperthyroidism or hypothyroidism);
- •Poor glucose control (defined as HbA1C≤ 9.5% within 3 months) if diagnosed with T2DM, or taking any antidiabetic medication that would affect metabolism or weight loss (i.e. TZD, GLP-1, DPP-4i or initially using insulin in the past 3 months);
- •Taking any medication (i.e. cortisol, methotrexate)that would affect steatohepatitis for more than two weeks in the past year;
- •Chronic kidney disease or severe impaired renal function (serum creatinine≥ 2.0mg/dl);
- •Serum alanine aminotransferase (ALT) greater than 300U/L
- •A history of Type 1 diabetes;
- •A history of bladder cancer;
- •Women who are pregnant or plan to become pregnant;
- •Serious medical disease with likely life expectancy less than 5 years;
- •Patients who cannot be followed for 24 months (due to a health situation or migration);
- •Participation in other clinical trial in the 30 days before randomization;
- •Patients who are unwilling or unable to give informed consent.
研究组 & 干预措施
Dapagliflozin group
Experimental
Participants will receive dapagliflozin 10mg po qd.
干预措施: Dapagliflozin (Drug)
Placebo group
Placebo Comparator
Participants will receive placebo po qd.
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in scored liver histological improvement over 12 months
时间窗: Baseline to 12 months
次要结局
- Change in waist circumference(Baseline to 12 months)
- Change in fibrosis score(Baseline to 12 months)
- Change in liver fat(Baseline to 12 months)
- Change in inflammatory markers of NASH(Baseline to 12 months)
- Change in health related quality of life scores (SF-36)(Baseline to 12 months)
- Improvement of fibrosis(Baseline to 12 months)
- Resolution of NASH(Baseline to 12 months)
- Change in each component score in the NAS(Baseline to 12 months)
- Change in body weight(Baseline to 12 months)
- Change in visceral fat(Baseline to 12 months)
- Change in HbA1C(Baseline to 12 months)
- Change in blood pressure(Baseline to 12 months)
- Change in insulin resistance(Baseline to 12 months)
- Change in serum lipids(Baseline to 12 months)
研究者
Huijie Zhang
Clinical Professor
Nanfang Hospital, Southern Medical University
研究点 (1)
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