NCT05397379已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Orally Administered HEC96719 Tablets in Adult Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis
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
- 68
- 试验地点
- 9
- 主要终点
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics of HEC96719 in non-cirrhotic NASH patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An informed consent document must be signed and dated by the subject
- •Male or female, 18 to 65 years of age
- •Body mass index (BMI)≥18.0 and≤35.0 kg/m2, and Weight≥40 kg;
- •Presumed NASH based on clinical characteristics or prior liver biopsy
- •MRI PDFF liver fat content ≥ 10 %
排除标准
- •previous diagnosis of other forms of chronic liver disease
- •Laboratory Screening Results:
- •AST > 5 x ULN
- •ALP > 3 x ULN
- •Total bilirubin > 1.5 x ULN
- •Albumin < 3.2 g/dL
- •INR > 1.3
- •Platelet count < 100,000 /mm3
- •creatinine clearance <60 ml/min (based on Cockroft Gault method)
- •previous exposure to OCA
- •uncontrolled diabetes mellitus
- •presence of cirrhosis
- •patients with contraindications to MRI imaging
研究组 & 干预措施
HEC96719 0.25 mg bid
Experimental
Oral dose twice daily for 12 weeks
干预措施: HEC96719 (Drug)
HEC96719 0.25 mg
Experimental
Oral dose once daily for 12 weeks
干预措施: HEC96719 (Drug)
HEC96719 0.35 mg
Experimental
Oral dose once daily for 12 weeks
干预措施: HEC96719 (Drug)
HEC96719 0.5 mg
Experimental
Oral dose once daily for 12 weeks
干预措施: HEC96719 (Drug)
Placebo
Placebo Comparator
Oral dose once or twice daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: 12 weeks
次要结局
- Mean Change From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 12(Baseline and Week 12)
- Plasma concentration of HEC96719 - t1/2(4 weeks)
- Plasma concentration of HEC96719 - Tmax(4 weeks)
- Plasma concentration of HEC96719 - AUC(4 weeks)
- Plasma concentration of HEC96719 - Cmax(4 weeks)
研究者
研究点 (9)
Loading locations...
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