A Randomized, Investigator and Subject Blinded, Multicenter, Parallel-arm Study to Determine the Safety and Tolerability of Tropifexor.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Change from baseline in fasting circulating LDL-C levels after 2 weeks of tropifexor treatment
研究概览
简要总结
The purpose of this study is to determine whether dosing tropifexor is safe and tolerable.
详细描述
This was a randomized, subject and investigator blinded, multicenter, parallel-arm study to assess the safety and tolerability of tropifexor dosed in the evening as compared to dosing in the morning in subjects with non-alcoholic steatohepatitis (NASH). Subjects whose eligibility was confirmed were randomized with stratification by domicile status at Day 1 of the treatment period into tropifexor (200 μg) AM dose group (hereafter referred to as AM dose group) or tropifexor (200 μg) PM dose group (hereafter referred to as PM dose group) in a 1:1 ratio. Subjects in the AM dose group took tropifexor in the morning and placebo in the evening while subjects in the PM dose group took placebo in the morning and tropifexor in the evening for 4 weeks in a blinded manner.
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
- Double (Participant, Investigator)
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
- •Presence of Liver Disease
排除标准
- •Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations.
- •Subjects taking the following medicines UNLESS on a stable dose (within 25% of baseline dose) for at least 3 months before randomization:
- •Type 1 diabetes and Uncontrolled Type 2 diabetes defined as Glycated hemoglobin (HbAlc) ≥ 9.5% at screening
- •Calculated estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73m2 (using the Modification of diet in renal disease (MDRD) formula) Subjects with contraindications to Magnetic resonance imaging (MRI) imaging.
研究组 & 干预措施
tropifexor AM 200 micrograms and Placebo (PM)
Tropifexor 200 μg (AM) and Placebo (PM) once daily each
干预措施: triopifexor (Drug)
tropifexor AM 200 micrograms and Placebo (PM)
Tropifexor 200 μg (AM) and Placebo (PM) once daily each
干预措施: Placebo (Drug)
tropifexor PM 200 micrograms and Placebo (AM)
Tropifexor 200 μg (PM) and Placebo (AM) once daily each
干预措施: triopifexor (Drug)
tropifexor PM 200 micrograms and Placebo (AM)
Tropifexor 200 μg (PM) and Placebo (AM) once daily each
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in fasting circulating LDL-C levels after 2 weeks of tropifexor treatment
时间窗: week 2
次要结局
- PK parameters include but not limited to area under the curve (AUC) will be assessed in the domiciled patients(4 weeks)
- Change in fasting circulating High density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C) levels over 4 weeks of treatment(week 4)
- PK parameters include but not limited to Cmax (ng/ml) will be assessed in the domiciled patients(week 4)
- Change in ALT, AST and GGT over 4 weeks of treatment(week 4)