NCT05591079已完成2 期
A Phase II, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of CS0159 in the Treatment of Patients With Nonalcoholic Steatohepatitis (NASH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 17
- 主要终点
- MRI-PDFF
研究概览
简要总结
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of CS0159 in subjects with Non-Alcoholic Steatohepatitis (NASH)
详细描述
This will be a multicenter, double-blind, randomized, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, PKs, and efficacy of CS0159 in the treatment of patients with NASH over 12 weeks.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the diagnosis of NASH.
- •Evidence of metabolic syndrome, except for those patients with biopsy-proven NASH.
- •Body mass index (BMI) >25 kg/m2, NOTE: for Asian-Americans BMI >23 kg/m
- •Stable use of other antidiabetic, weight loss, or lipid-modifying medications for at least 12 weeks prior to randomization.
排除标准
- •Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
- •Previous exposure to farnesoid X receptor (FXR) agonists 3 months prior to the first dosing.
- •Current or within 6 months of screening use of drugs associated with steatosis, including but not limited to eg, methotrexate, amiodarone, high-dose estrogen, tamoxifen, long term systemic steroids, anabolic steroids, valproic acid.
- •Prothrombin time international normalized ratio >1.3, unless due to therapeutic anticoagulation.
- •Total bilirubin >upper limit of normal (ULN; except for patients with Gilbert's syndrome with a normal direct bilirubin value and normal reticulocyte count).
- •Platelet count <140 000/mm³, absolute neutrophil count <1500 cells/mm3, or total
- •white blood cells <3000 cells/mm
- •Alanine aminotransferase and aspartate aminotransferase (AST) >5 × ULN, or alkaline phosphatase (ALP) >1.5 × ULN.
- •Weight changes >10% in 6 months prior to screening, or weight changes >5% from the screening MRI-PDFF to randomization or from the time of the diagnostic liver biopsy to randomization, whichever is longer.
- •Poorly controlled hypertension (systolic >160 mm Hg, or diastolic blood pressure >100 mm Hg - mean of 3 measurements).
- •Uncontrolled diabetes mellitus (hemoglobin A1c >10.0% during screening).
研究组 & 干预措施
1.4mg CS0159
Experimental
One tablet daily for 12 weeks
干预措施: CS0159 (Linafexor) (Drug)
2mg CS0159
Experimental
One tablet daily for 12 weeks
干预措施: CS0159 (Linafexor) (Drug)
PLACEBO
Placebo Comparator
One tablet daily for 12 weeks
干预措施: CS0159 (Linafexor) (Drug)
结局指标
主要结局
MRI-PDFF
时间窗: Week 12
To assess the changes in liver steatosis through magnetic resonance imaging (MRI) proton density fat fraction (PDFF) from baseline to Week 12
Adverse events
时间窗: Week 12
To evaluate the safety and tolerability of CS0159 in patients with NASH treated over 12 weeks
次要结局
- Pharmacodynamics (PD)(week 6, week 12)
- tmax(week 6, week 12)
- AUC(week 6, week 12)
- Cmax(week 6, week 12)
- t1/2(week 6, week 12)
研究者
研究点 (17)
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