NCT02491905已完成2 期
Phase 2 Study to Assess Safety and Efficacy of HL Tablet on Reducing Hepatic Fat in Non-alcoholic Fatty Liver Disease Patients
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
- 69
- 试验地点
- 1
- 主要终点
- To assess the change of hepatic fat by Magnetic Resonance spectroscopy (MRS) after administration of HL tablet compared with baseline
研究概览
简要总结
This study evaluates the safety and efficacy of HL tablet on reducing hepatic fat in non-alcoholic fatty liver disease patients. The patients are allocated to three groups; low dose, high dose, and placebo control group.
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 19 and 75
- •Non-alcoholic fatty liver disease patient
- •Diagnosed by abdomen ultrasonic examination
- •Non-drinker (alcohol intake per week : female-under 140g, male-under 210g)
- •ALT or AST higher than normal range (not over 4 times normal range)
- •Voluntary agreement and enrollment
排除标准
- •The ratio of AST/ALT over 2
- •Type I diabetes mellitus patient
- •Any dysfunction of liver besides non-alcoholic fatty liver disease
- •Alcoholic fatty liver disease patient or heavy drinker
- •Prior treatment with any medicine which affects the treatment of non-alcoholic fatty liver disease within 3 months
- •Patient taking any product which affects the BMI or hyperlipidemia
- •Any dyscrasia that investigator considers not to appropriate for this study
- •Bariatric surgery within 6 months
- •Any disease which is able to change the distribution of cytokines
- •Any treatment that affects liver functions within 1 month
- •Participation in other clinical trials within 3 months
- •Person who can not use MRS
- •Pregnancy or breast-feeding
- •Fertile women who do not use contraception
- •Sensitive to the investigational product
- •Any conditions that the investigator considers not to appropriate for this study
研究组 & 干预措施
low dose HL tablet
Experimental
HL tablet which contains 66.7mg of active compound by oral administration, twice daily in an hour after meal
干预措施: HL tablet (Drug)
high dose HL tablet
Experimental
HL tablet which contains 200mg of active compound by oral administration, twice daily in an hour after meal
干预措施: HL tablet (Drug)
placebo group
Placebo Comparator
Placebo by oral administration, twice daily in an hour after meal
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the change of hepatic fat by Magnetic Resonance spectroscopy (MRS) after administration of HL tablet compared with baseline
时间窗: 12 weeks
次要结局
- Changes in insulin resistance(8 and 12 week)
- Changes in Alanine Transaminase (ALT)(8 and 12 week)
- Changes in triglyceride(8 and 12 week)
- Changes in free fatty acid(8 and 12 week)
- Changes in Asparate Transaminase (AST)(8 and 12 week)
- Changes in cholesterol(8 and 12 week)
- Changes in Body Mass Index (BMI)(8 and 12 week)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy SubjectsNon-alcoholic Fatty Liver DiseaseNon-alcoholic SteatohepatitisNCT04422496Sunshine Lake Pharma Co., Ltd.73
进行中（未招募）
不适用
Phase II study to evaluate hepatic function and clinical aspects in patients with severe hepatic cirrhosis treated with multiple cycle of stem cells mobilisation by G-CSF administration. - NDHepatic cirrhosis with severe liver dysfunctionMedDRA version: 6.1Level: PTClassification code 10019663EUCTR2007-001705-21-ITAZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO
已完成
2 期
Phase 2 Study of HL-009 Liposomal Gel to Treat Mild to Moderate Atopic DermatitisMild to Moderate Atopic DermatitisNCT01568489HanAll BioPharma Co., Ltd.120
进行中（未招募）
2 期
A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)Non-alcoholic Fatty Liver DiseaseNonalcoholic SteatohepatitisNAFLDMetabolic Dysfunction-associated Steatotic Liver DiseaseMetabolic Dysfunction-associated SteatohepatitisNCT06465186Merck Sharp & Dohme LLC80
已完成
1 期
Hepatic Impairment Study With MDV3100 in Subjects With Mild and Moderate Hepatic Impairment Compared to a Healthy Control GroupPharmacokinetics of MDV3100Healthy SubjectsKidney DiseasesNCT01901133Astellas Pharma Europe B.V.33