NCT05464784进行中（未招募）2 期
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of MN-001 in Patients Diagnosed With Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- MediciNova
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Mean change from baseline in fasting serum triglyceride levels at Week 24
研究概览
简要总结
The design of the Phase 2 clinical trial includes the following elements:
- Multi-center, two-arm, randomized, double-blind, placebo-controlled trial to evaluate MN-001 (tipelukast) vs. placebo in approximately 40 patients in the U.S.
- Patients will be randomized 1:1 to receive either 500 mg/day of MN-001 (tipelukast) or placebo for 24 weeks.
- The co-primary endpoints are (1) change from baseline in liver fat content measured by controlled attenuation parameter (CAP) score at Week 24, and (2) change from baseline in fasting serum triglycerides at Week 24. FibroScan® is a non-invasive, quantitative, and accurate measure of liver fat content commonly used in early phase trials to measure treatment response.
- Secondary endpoints include safety and tolerability and changes in lipid profile (HDL-C, LDL-C, and total cholesterol).
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FibroScan® CAP score ≥ 248 dB/m within 8 weeks of randomization.
- •Diagnosis or history of Type 2 Diabetes mellitus with hemoglobin A1c (HbA1c) >6.5 and ≤10% at Screening.
- •Fasting serum triglycerides (TG) at Screening >150 mg/dL
- •On a stable dose of oral antidiabetic therapy for a minimum of 3 months prior to Screening.
排除标准
- •Other causes of chronic liver disease (autoimmune, primary biliary cholangitis, HBV, HCV, Wilson's, α-1-antitrypsin deficiency, hemochromatosis, biopsy-proven cirrhosis, hepatocellular carcinoma);
- •Documented history of advanced liver fibrosis
- •Evidence of cirrhosis, hepatic decompensation, portal hypertension including splenomegaly, ascites, encephalopathy and/or esophageal varices;
- •Diagnosis or history of Diabetes mellitus type 1;
- •Weight change >5% within last 3 months of Screening visit;
- •Active gastrointestinal disease or history of gastric bypass surgery which could interfere with the absorption of oral medication;
- •History of clinically significant acute cardiac event within 6 months of Screening;
研究组 & 干预措施
MN-001
Experimental
干预措施: MN-001 (Drug)
MN-001 Placebo
Placebo Comparator
The placebo comparator is a tablet identical in appearance to MN-001.
干预措施: MN-001 placebo (Drug)
结局指标
主要结局
Mean change from baseline in fasting serum triglyceride levels at Week 24
时间窗: Week 24
Mean change in controlled attenuation parameter (CAP) score by sound-based elastography at Week 24
时间窗: Week 24
次要结局
- Mean change from baseline in lipids(Baseline to Week 24)
- Safety and tolerability of MN-001(Baseline to Week 24)
研究者
研究点 (2)
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