A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Assess the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Poxel SA
- 入组人数
- 121
- 试验地点
- 15
- 主要终点
- Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Unstratified Wilcoxon Sensitivity Analysis)
研究概览
简要总结
This study will assess the efficacy and safety of 3 doses of PXL770 versus placebo after 12 weeks of treatment.
详细描述
The study will be performed in patients with Nonalcoholic Fatty Liver Disease. The primary endpoint will be the assessment of the change in the percentage of liver fat mass (assessed by MRI-PDFF).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have given written informed consent
- •Body mass index (BMI) ≥ 25 to ≤ 50 kg/m²
- •For patients with type 2 diabetes mellitus: either naive of glucose lowering drug or under stable oral glucose lowering drug
- •Estimated glomerular filtration rate (eGFR) ≥ 60 mL/[min*1.73m²]
- •Alanine amino transferase (ALT) > 20 IU/L in females and > 30 IU/L in males
- •Hepatic steatosis (MRI-PDFF ≥ 10%)
- •Effective contraception for women of child bearing potential
排除标准
- •Evidence of another form of liver disease
- •Evidence of liver cirrhosis
- •Evidence of hepatic impairment
- •Positive serologic evidence of current infectious liver disease
- •History of excessive alcohol intake
- •Acute cardiovascular disease with 24 weeks prior to screening
- •Uncontrolled high blood pressure
- •Any disease which in the Investigator's opinion which in the Investigator's opinion would exclude the patient from the study
- •Use of non-permitted concomitant medication
- •Pregnancy or lactation
研究组 & 干预措施
Group 1
PXL770 Dose 1
干预措施: PXL770 (Drug)
Group 2
PXL770 Dose 2
干预措施: PXL770 (Drug)
Group 3
PXL770 Dose 3
干预措施: PXL770 (Drug)
Group 4
Placebo oral capsule
干预措施: Placebo Oral Capsule (Drug)
结局指标
主要结局
Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Unstratified Wilcoxon Sensitivity Analysis)
时间窗: Baseline to Week 12
MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
Relative Change in the Percentage of Liver Fat Mass (Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction [MRI-PDFF]) From Baseline to Week 12/End of Treatment (EOT)
时间窗: Baseline to Week 12
MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 region of interest (ROI) was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Per Protocol Sensitivity Analysis)
时间窗: Baseline to Week 12
MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Subgroup Analysis - Type 2 Diabetes Mellitus [T2DM])
时间窗: Baseline to Week 12
MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
次要结局
- Percentage of Responders (Relative Reduction of at Least 30% in Liver Fat Mass) at Week 12/End of Treatment(Baseline to Week 12)
- Change in Alanine Amino Transferase (ALT) From Baseline to Week 12/End of Treatment(Baseline to Week 12)
- Change in Body Weight From Baseline to Week 12/End of Treatment(Baseline to Week 12)
- Change in Aspartate Amino Transferase (AST) From Baseline to Week 12/End of Treatment(Baseline to Week 12)
- Absolute Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment(Baseline to Week 12)
- Change in Fibrosis-4 (Fib-4) Score From Baseline to Week 12/End of Treatment(Baseline to Week 12)
- Change in Fasting Plasma Glucose (FPG) From Baseline to Week12/End of Treatment(Baseline to Week 12)
- Change in High Density Lipoprotein-Cholesterol (HDL-C) From Baseline to Week12/End of Treatment(Baseline to Week 12)
- Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Week12/End of Treatment(Baseline to Week 12)
- Change in Triglycerides From Baseline to Week12/End of Treatment(Baseline to Week 12)
- Change in Glycated Hemoglobin (HbA1c) From Baseline to Week12/End of Treatment(Baseline to Week 12)
- Change in Total Cholesterol From Baseline to Week12/End of Treatment(Baseline to Week 12)