NCT05193916已完成2 期
A Multi-Center, Randomised, Double-blind, Placebo Controlled Phase II Clinical Study of Chiglitazar in Patients With Nonalcoholic Steatohepatitis Accompanied by Elevated Triglycerides and Insulin Resistance
Chipscreen Biosciences, Ltd.15 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2022年3月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 15
- 主要终点
- Percentage change from baseline to week 18 in liver fat content as measured by MRI using the proton density fat fraction (MRI-PDFF)
研究概览
简要总结
The study is to evaluate the efficacy and safety of chiglitazar monotherapy in patients with non-clcoholic steatohepatitis (NASH).
详细描述
The study is a non-invasive exploratory phase II trial in patients who were clinically diagnosed as non-alcoholic steatohepatitis (NASH) with liver fibrosis accompanied by elevated triglycerides (TG) and insulin resistance. The efficacy and safety of chiglitazar tablets 48mg and 64mg will be compared with placebo in the 18-week-treament.
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
- •Before any evaluation, an informed consent form voluntarily signed by the patient must be obtained;
- •18 -75 years old (at the time of screening visit V1), male or female;
- •MRI-PDFF ≥ 8% ;
- •Liver stiffness value ( LSM ) 7.0-11.0kPa ;
- •Triglyceride ( TG ) ≥1.7mmol/L and ≤5.6 mmol/L;
- •HOMA-IR ≥ 2.5 ;
- •Serum Alanine aminotransferease (ALT) ≥ the upper limit of normal during screening.
排除标准
- •Type 1 diabetes;
- •Any of the following for type 2 diabetes:
- •HbA1c ≥ 8.5% during screening
- •At the time of screening, ≥ 2 oral hypoglycemic drugs combinations
- •Receiving any of the following medications at screening: Thiazolidinediones (TZD) drugs, fibrates, glucagon-like peptide-1 (GLP-1) receptor agonists, insulin
- •Existing other liver diseases or history of liver diseases
- •History of transient ischemic attack or cerebrovascular accident;
- •History of myocardial infarction, or coronary angioplasty or coronary artery bypass surgery, unstable angina, heart failure (New York Heart Association NYHA grade III / IV ), or ECG signs of left ventricular hypertrophy, or serious arrhythmias ；
- •During screening, blood pressure ≥ 160/100 mmHg ;
- •Previous or planned ( during the study period) bariatric surgery;
- •Liver transplantation history or planned liver transplantation;
- •Liver biopsy show liver cirrhosis or clinically diagnosed as cirrhosis;
- •Weight loss of more than 5% in 6 months before screening;
- •History of edema of lower limbs or whole body;
- •diagnosed as osteoporosis or any other known bone disease;
- •Donated blood or lost blood >400 ml within 8 weeks before the first medication;
- •With MRI scan contraindications;
- •In the past 5 years, there was a history of malignant tumors of any organ system;
- •Human immunodeficiency virus ( HIV ) test is positive;
- •Heavy drinking of alcohol for more than 3 months in a year;
- •Heavy smoking >30 per day within 1 year;
- •History of drug abuse in 12 months;
- •Drugs cumulatively for more than 1 month in the previous 3 months before screening, such as obeticholic acid ( OCA ), berberine;
- •Drugs that may cause liver damage for more than 2 weeks within 1 year before screening;
- •Patients received the following medications unless they have received a stable dose for at least 1 month before screening :Beta-blockers, thiazide diuretics, statins, niacin, ezetimibe, thyroid hormone;
- •The calculated eGFR < 60 mL/(min*1.73m^2 );
- •There is clinical evidence of liver decompensation or severe liver damage;
- •Low density lipoprotein cholesterol (LDL-C) ≥ 3.4 mmol/L during screening ;
- •Platelet < 100×10^9 /L ;
- •Patient participating in other clinical trials of drugs or medical devices within 3 months prior to screening ;
- •Pregnant or breastfeeding women.
研究组 & 干预措施
Chiglitazar high dose
Experimental
4 tablets p.o. per day
干预措施: chiglitazar sodium tablets (Drug)
Chiglitazar low dose
Experimental
3 tablets of drug and 1 tablet of placebo p.o. per day
干预措施: chiglitazar sodium tablets (Drug)
control group
Placebo Comparator
4 placebo tablets p.o. per day
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage change from baseline to week 18 in liver fat content as measured by MRI using the proton density fat fraction (MRI-PDFF)
时间窗: 18 weeks
center reading for the primary endpoint
次要结局
- ALT changes from baseline(6,12,18 weeks)
- the change in liver fat content from baseline as shown by MRI-PDFF after 18 weeks treatment(18 weeks)
- insulin resistance changes(6,12,18 weeks)
- Changes from baseline in TG(6,12,18 weeks)
- change from baseline in Liver stiffness measurement (LSM) with Fibroscan(6,12,18 weeks)
- change from baseline in Cytokeratin18 (CK-18)(6,12,18 weeks)
- Maximum Plasma Concentration [Cmax] of chiglitazar after 1 dose, 6 weeks and 12 weeks of treatment(0, 6,12 weeks)
- The area under the plasma drug concentration-time curve [AUC] of chiglitazar after 1 dose, 6 weeks and 12 weeks of treatment(0, 6,12 weeks)
- FIB-4 changes from baseline(6,12,18 weeks)
研究者
研究点 (15)
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